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Re: Vertex Protease Inhibitor

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Still has to go through the dreaded FDA, and trust me, I am not

the only one waiting, we are many.. :)

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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well please dont be holding your breath thenJackie

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Vx-950 was put on the fda fast track list last year ,,,,,, so I think it will not be that long before we can both give it a shot (pun) lol

[Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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I hope so,, what was that one new drug that they used that the monkeys started dying from?Jackie

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Not that I am aware of , but ya never know . I will do some diggin but I don't think this is the drug .

[Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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I dont think it was either,, I just cannot remember what the name of that other one was..btw, how is your job going? You still able to keep up?'s been having more belly pains but in a different area,, more in her transverse colon area,, we see the doc again on thurs.. say a prayer that its nothing serious..Jackie

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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After a particlularly long night I received a message to go to the hospital . My legs and feet had +5 pitting pedal edemal . More than likely from CHF ,so I was put on lasix and potassium . Then I went to work and put in notice until my problems are better .

[Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Not encouraging, however I am sure it is not the same.

The drug I am referring to is in Phase 3 clinical trials

and used along with Interferon and Ribavirin.

Sheena

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Actually, I am more than anxious to treat again, but not before

I am sure I can reach SVR.. Thanks, I won't hold

my breath, though, I do know these things take time.

I just have Faith that they will happen..

Sheena

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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I know honey.. its really too bad that last time you tried to treat that inspite of becoming undetctible, you were not able to get your doc to treat your sides as he promised and your dear hubby had such medical issues,, all in that same time frame...I DO believe you will become SVR as you did respond so well to tx.... Jackie

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Thanks, I really believe so, too..Life, it has a way of

happening, have to roll with the punches..then pick

up the pieces and move on..

Sheena

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Im sure you're right...Jackie

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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I can only hope, time will tell, but I do like to remain positive

when I can..

Sheena

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Honey, you're one of the most positive people I've ever known,,Jackie

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Oh Liz, Im so sorry hon,, maybe being on your feet right now is not the best thing for you. Were you having trouble breathing (chf)? Any Pulmonary edema? PLEASE take care of yourself,,,,, we love you!Jackie

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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oh you got that right Sheena... life does roll onJackie

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 ( Telaprvir)

Press announcement distributed by Vertex. CAMBRIDGE, Mass., Dec. 8 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor for the treatment of HCV infection. The FDA granted Fast Track designation to VX-950 for the following reasons: - Chronic hepatitis C virus infection is a serious and life-threatening disease. - VX-950 has the potential to shorten the duration of therapy compared to the standard of care, which may result in improved sustained virologic response rates and a more favorable adverse event profile. Vertex is currently conducting a clinical development program to assess whether VX-950 will address these unmet medical needs in HCV therapy. Under the FDA Modernization Act of 1997, Fast Track designation indicates that the FDA will facilitate the development and may expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. VX-950 Clinical Status Earlier in 2005, Vertex concluded a 14-day, Phase Ib study of VX-950 that showed a rapid and dramatic reduction in HCV RNA in HCV patients when VX-950 was administered as a single agent. Overall in the Phase Ib study, adverse events observed in patients receiving VX-950 that were considered possibly related to the drug were mild, and generally similar in frequency to events in the placebo group. The most common adverse events reported in both placebo and VX-950 patients were headache, frequent urination and gastrointestinal symptoms. Based on these encouraging Phase Ib clinical results, Vertex recently initiated two additional clinical studies with VX-950. In October 2005, Vertex initiated in Europe a 20-patient Phase Ib study of VX-950 dosed in combination with pegylated interferon. In December 2005, Vertex initiated in the United States the first Phase II study of VX-950, which will evaluate the safety, tolerability and pharmacodynamics of VX-950 when dosed with pegylated interferon and ribavirin. Vertex expects to obtain results from both these Phase Ib and Phase II studies of VX-950 in early 2006. Vertex also expects to initiate multiple additional Phase II studies in the United States in 2006, including a three-month study in more than 200 treatment-naive patients.

[Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Luv to Sheena but I am right the fda granted fast track to this drug and should be available sometime before the end of the yr .

[Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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More than likely its chf , there was some sob but after they gave me iv lasix it went away and little by little the swelling has gone away . My ekg was abnormal and so I do need to follow up with my cardiologist .

[Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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well it does sound like you had some pulmonary edema then.. Im glad its getting better,, Jackie

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Yup definately some pe but now soooo much better . I just have to find the time to see my heart doc . I just dont have the time with all my other doctor visits lol

[Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Love to you, too sweetie, wahoo, here we go!

Everybody get in line!

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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I was referring to not thinking it was the same drug that Jackie

thought was killing off the monkeys, that's what I meant when

I spoke of it not thinking it was the same..

There is another drug in phase 3, however, I will have to look for

it, thought sure it was Vertex, too.. It is good to know that the FDA is

fast tracking something, many waiting..

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg

telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus

ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new

agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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well hon, dont neglect your heart,, remember, if it dont beat, you dont live,, Jackie

From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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Way back in 2005 there was another drug in clinical trials that had to discontinued because of cardiac issues . But this is the one that came after and I have had my eyes on it ever since lol

[Hepatitis_C_ Central] Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and ITo: Hepatitis_C_ Central@yahoogro ups.comDate: Tuesday, July 22, 2008, 1:06 PM

Telaprevir plus Pegylated Interferon and Ribavirin Produces Rapid Response and Is Well Tolerated in 28-day Study By Liz HighleymanGiven the limited efficacy and difficult side effects of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers are studying a variety of oral antiviral agents that directly target different steps of the viral lifecycle. One of the most promising is telaprevir (previously known as VX-950), an experimental HCV NS34A protease inhibitor being developed by Vertex Pharmaceuticals and Tibotec. As reported in the August 2008 Journal of Hepatology, Lawitz and colleagues conducted a small trial to assess the safety and antiviral activity of telaprevir added to standard combination therapy for chronic hepatitis C. The study included 12 treatment-naive patients with chronic genotype 1 HCV infection. All received 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin for 28 days. At the discretion of the investigator and patient, participants could then commence off-study treatment with Pegasys plus ribavirin without telaprevir for up to 44 weeks (for a total of 48 weeks, the standard duration of therapy for genotype 1). Results• The combination of telaprevir, pegylated interferon, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. • Rash or pruritus (itching) occurred in 5 of the 12 patients; all cases resolved either during or after completion of telaprevir treatment. • All 12 patients experienced rapid viral response (RVR), or undetectable HCV RNA levels by day 28. • 8 of the participants underwent 44 weeks of off-study pegylated interferon plus ribavirin after finishing the telaprevir phase.• All 8 achieved sustained viral response (SVR), or undetectable HCV RNA 24 weeks after completion of therapy.• 1 individual who received only 22 weeks of treatment achieved SVR. In conclusion, the study authors wrote, "The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR."While this is one of the first studies of telaprevir to be published in a peer-reviewed journal, data from the larger and longer PROVE-1, PROVE-2, and PROVE-3 trials have been reported at recent scientific meetings.A majority of experts expect that directly targeted anti-HCV agents such as telaprevir will have to be used in combination with interferon for the foreseeable future, but addition of the new agents may allow for shorter therapy.Alamo Medical Research, San , TX; Fundacion de Investigacion de Diego San , Puerto Rico; Duke Clinical Research Institute, Duke University, Durham, NC; Vertex Pharmaceuticals Incorporated, Cambridge, MA.7/22/08References

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