PEGASYS and COPEGUS Now Offers Benefits in a Wider Range of Hepatitis C Patients

[Guest guest]

http://www.hcvadvocate.org/news/newsRev/2004/NewsRev-44.html

PEGASYS and COPEGUS Now Offers Benefits in a Wider Range of Hepatitis C

Patients

Source: Roche Press Release

New Data Presented At European Liver Meeting On Two Multinational Trials

Basel, Switzerland –– New data from two pioneering hepatitis C (HCV) studies

with PEGASYS® plus COPEGUS® will be presented this week at the 39th Annual

Meeting of the European Association for the Study of the Liver (EASL) in

Berlin. The multinational trials – one in patients with HIV-HCV co-infection

and the other in HCV patients with persistently normal levels of alanine

aminotransferase (ALT) –demonstrate that PEGASYS plus COPEGUS is an

effective, safe and predictable treatment option.

Final results of APRICOT report highest ever treatment response in

co-infected patients

The final results of APRICOT (AIDS PEGASYS— Ribavirin International

CO-infection Trial) – the largest and only multinational study evaluating

the efficacy and safety of pegylated interferon combination therapy in

people co-infected with HIV and HCV – found that the combination of PEGASYS

and COPEGUS achieved a 40% sustained virological response (SVR) – the

highest ever reported in a trial of co-infected patients.

“APRICOT provides the guidance that we have wanted on how best to treat

co-infected patients and there is no doubt that the combination of PEGASYS

and COPEGUS represents the best we can currently offer this patient

population,” said Dr. Francesca Torriani, Associate Professor of Medicine,

Antiviral Research Centre, University of California at San Diego and one of

the APRICOT lead investigators. “What’s more, we now have data from this

trial on our ability to confidently predict as early as week 12 of therapy

which patients are likely to achieve a sustained virological response.”

The key APRICOT findings that Dr. Torriani will present on Sunday, April

18th are:

• 40% of patients treated with PEGASYS plus COPEGUS achieved an SVR compared

to 20% of patients treated with PEGASYS monotherapy and 12% of patients

treated with conventional interferon/ribavirin.

• Genotype 1 patients treated with PEGASYS plus COPEGUS achieved a four-fold

increase in SVR compared to conventional interferon/ribavirin (29% vs 7%).

• 62% of genotype 2/3 patients treated with PEGASYS plus COPEGUS combination

therapy achieved an SVR compared to 20% with conventional

interferon/ribavirin.

New APRICOT data identifies patients most likely to respond

New data will be presented on APRICOT that will help physicians identify

those patients with the best chance of achieving an SVR. 71% of co-infected

patients achieved an EVR following 12 weeks of a fixed 180µg/week dose of

PEGASYS and 800mg daily of COPEGUS (ribavirin), and of those, more than half

(56%) achieved an SVR. Among patients with the more difficult-to-treat HCV

genotype 1, 45% who had an EVR went on to achieve a sustained virological

response. The ability to tell patients at week 12 if their treatment is

likely to generate an SVR, is now recognized as having an important role in

the motivation of patients to start with, and stay on, therapy.

Real world patient population in APRICOT

The patients in this landmark study were predominantly male, middle-aged

with stable HIV disease. However, patients had a wide range of HIV status;

the majority were on anti-retroviral therapy and they had very high HCV

viral loads (10-15 million copies/ml). The very low (12%) response achieved

by patients to the arm receiving conventional interferon combination therapy

is illustrative of the challenging nature of the co-infection present in

these patients.

European Union contributes nearly half the patients

422 of the 868 patients randomized in APRICOT came from 11 European Union

countries – a total of 19 countries participated. These patients were

randomized to receive either PEGASYS 180µg once weekly plus COPEGUS 800mg

daily; PEGASYS 180µg monotherapy once weekly (plus placebo COPEGUS tablets),

or conventional interferon alfa-2a 3MIU three times a week in combination

with ribavirin 800mg daily, all for 48 weeks.

New data on quality of life from second landmark trial in patients with

normal ALT

A substantial proportion of hepatitis C patients have ‘normal’ levels of ALT

(an enzyme present in the blood used historically as a marker for liver

injury and disease). Because these levels are ‘normal’, these patients were

traditionally considered to have ‘mild’ hepatitis and therefore did not need

to be treated. More recently, however, there has been a growing awareness

that ALT is actually a poor marker of liver disease. Indeed, all patients in

this trial had evidence of liver inflammation and nearly one third had some

degree of fibrosis.

In the only global trial in this group of patients, 514 patients were

randomized to receive either PEGASYS 180µg once weekly plus COPEGUS 800mg

daily for either 24 or 48 weeks, followed by a 24-week treatment-free

follow-up period. A third arm was an untreated control group, since no

treatment was considered the standard of care at the time the study was

designed.

The key trial findings were:

• Overall 52% of hepatitis C patients with ‘normal’ ALT levels achieved an

SVR while none in the control arm did. These results are consistent with the

excellent results seen in other patient populations treated with PEGASYS

plus COPEGUS.

• 72% of PEGASYS patients infected with genotypes 2 or 3 who were treated

for 24 weeks and 40% of PEGASYS patients infected with the

‘difficult-to-treat’ genotype 1 who were treated for 48 weeks achieved an

SVR.

New data presented at EASL noted that:

• Those who achieved an SVR reported a better QoL including reduced fatigue

than both the untreated control group and those who failed to achieve an

SVR.

• Those patients who failed to achieve an EVR following 12 weeks of therapy

were highly unlikely to achieve an SVR. As in other HCV patient groups, this

provides an early and meaningful time point for physicians and patients to

discuss the benefits of continuing with treatment if viral eradication may

not be achieved.

“The results of this trial are very important because until now it was not

clear if there were benefits to treating these patients – which account for

about 30% of patients with chronic hepatitis C,” said Professor Stefan

Zeuzem, from Saarland University, Homburg, Germany. “Now, we know these

patients can be effectively treated like other patients with hepatitis C and

experience improvements in their quality of life.”

New trial underway by Roche in another difficult-to-treat group of patients

Recently Roche announced the launch of the first global trial to study the

efficacy of PEGASYS plus COPEGUS in another difficult-to-treat patient

population: hepatitis C patients who failed to respond to peginterferon

alfa-2b plus ribavirin combination therapy. This trial is known as REPEAT,

which stands for " Retreatment with PEGASYS in patients not responding to

prior peginterferon alfa-2b/ribavirin combination therapy " . The REPEAT study

will evaluate the efficacy and safety of the combination of PEGASYS and

COPEGUS given for a longer, 72-week period, as well as examining the role of

an induction regimen in this treatment- resistant population.

Close to 1,000 patients will participate in this study from Europe, North

America and Latin America.

About PEGASYS

PEGASYS, a new generation hepatitis C therapy that is different by design,

provides significant benefit over conventional interferon therapy in

patients infected with HBV and HCV. The benefits of PEGASYS are derived from

its new generation large 40 kilodalton (KD) branched-chain polyethylene

glycol (PEG) construction, which allows for sustained drug levels over the

course of a full week. PEGASYS also distributes more readily to the liver

(the primary site of infection) than conventional interferon. In HCV PEGASYS

provides superior efficacy compared to conventional interferon combination

therapy in HCV patients of all genotypes. PEGASYS is the only pegylated

interferon available as a ready-to-administer solution. Each weekly

subcutaneous injection contains 180mcg of pegylated interferon alfa-2a

(40KD) which is the approved dose for all patients, regardless of body

weight.

All trademarks used or mentioned in this release are legally protected.

Film footage is available for broadcast journalists from The NewsMarket at

www.thenewsmarket.com. Video is compressed in MPEG2 and is available for

download to your FTP server.

REFERENCES:

•Torriani FJ, Rockstroh J, - M, et al. Final week-72 results

of the AIDS Pegasys Ribavirin International Co-infection Trial (APRICOT): A

randomized, partially-blinded, multinational comparative trial of

peginterferon alfa-2a (40KD) (PEGASYS®) plus ribavirin (RBV) (COPEGUS®) vs

interferon alfa-2a (IFN) plus RBV in the treatment of HCV in HIV/HCV

co-infection. EASL oral presentation, 2004.

•M. -, Torriani FJ, Lissen E, et al. Early Prediction of

Sustained Virological Response (SVR) During Treatment with Peginterferon

Alfa-2a (40KD) (PEGASYS) Plus Ribavirin (RBV) (COPEGUS) In Patients With

HCV/HIV Co-infection: Results From The AIDS PEGASYS Ribavirin International

Co-Infection Trial (APRICOT) Study. EASL abstract, 2004.

•O’Brien C, Wintfeld N, Patel KK, et al. The impact of sustained virological

response (SVR) on health-related quality of life (HRQL) in patients with

chronic hepatitis C (CHC) and persistently normal ALT levels (PNALT) treated

with peginterferon alfa-2a (PEGASYS®) and ribavirin (COPEGUS®). EASL

abstract, 2004.

•Pockros PJ, Diago M, Gane E, et al. Early prediction of sustained

virological response (SVR) during treatment with peginterferon alfa-2a

(40KD) (PEGASYS®) plus ribavirin (RBV) (COPEGUS®) in patients with chronic

hepatitis C (CHC) and persistently normal alanine aminotransferase (ALT)

levels: Results of a multinational trial. EASL abstract, 2004.

[Guest guest]

http://www.hcvadvocate.org/news/newsRev/2004/NewsRev-44.html

PEGASYS and COPEGUS Now Offers Benefits in a Wider Range of Hepatitis C

Patients

Source: Roche Press Release

New Data Presented At European Liver Meeting On Two Multinational Trials

Basel, Switzerland –– New data from two pioneering hepatitis C (HCV) studies

with PEGASYS® plus COPEGUS® will be presented this week at the 39th Annual

Meeting of the European Association for the Study of the Liver (EASL) in

Berlin. The multinational trials – one in patients with HIV-HCV co-infection

and the other in HCV patients with persistently normal levels of alanine

aminotransferase (ALT) –demonstrate that PEGASYS plus COPEGUS is an

effective, safe and predictable treatment option.

Final results of APRICOT report highest ever treatment response in

co-infected patients

The final results of APRICOT (AIDS PEGASYS— Ribavirin International

CO-infection Trial) – the largest and only multinational study evaluating

the efficacy and safety of pegylated interferon combination therapy in

people co-infected with HIV and HCV – found that the combination of PEGASYS

and COPEGUS achieved a 40% sustained virological response (SVR) – the

highest ever reported in a trial of co-infected patients.

“APRICOT provides the guidance that we have wanted on how best to treat

co-infected patients and there is no doubt that the combination of PEGASYS

and COPEGUS represents the best we can currently offer this patient

population,” said Dr. Francesca Torriani, Associate Professor of Medicine,

Antiviral Research Centre, University of California at San Diego and one of

the APRICOT lead investigators. “What’s more, we now have data from this

trial on our ability to confidently predict as early as week 12 of therapy

which patients are likely to achieve a sustained virological response.”

The key APRICOT findings that Dr. Torriani will present on Sunday, April

18th are:

• 40% of patients treated with PEGASYS plus COPEGUS achieved an SVR compared

to 20% of patients treated with PEGASYS monotherapy and 12% of patients

treated with conventional interferon/ribavirin.

• Genotype 1 patients treated with PEGASYS plus COPEGUS achieved a four-fold

increase in SVR compared to conventional interferon/ribavirin (29% vs 7%).

• 62% of genotype 2/3 patients treated with PEGASYS plus COPEGUS combination

therapy achieved an SVR compared to 20% with conventional

interferon/ribavirin.

New APRICOT data identifies patients most likely to respond

New data will be presented on APRICOT that will help physicians identify

those patients with the best chance of achieving an SVR. 71% of co-infected

patients achieved an EVR following 12 weeks of a fixed 180µg/week dose of

PEGASYS and 800mg daily of COPEGUS (ribavirin), and of those, more than half

(56%) achieved an SVR. Among patients with the more difficult-to-treat HCV

genotype 1, 45% who had an EVR went on to achieve a sustained virological

response. The ability to tell patients at week 12 if their treatment is

likely to generate an SVR, is now recognized as having an important role in

the motivation of patients to start with, and stay on, therapy.

Real world patient population in APRICOT

The patients in this landmark study were predominantly male, middle-aged

with stable HIV disease. However, patients had a wide range of HIV status;

the majority were on anti-retroviral therapy and they had very high HCV

viral loads (10-15 million copies/ml). The very low (12%) response achieved

by patients to the arm receiving conventional interferon combination therapy

is illustrative of the challenging nature of the co-infection present in

these patients.

European Union contributes nearly half the patients

422 of the 868 patients randomized in APRICOT came from 11 European Union

countries – a total of 19 countries participated. These patients were

randomized to receive either PEGASYS 180µg once weekly plus COPEGUS 800mg

daily; PEGASYS 180µg monotherapy once weekly (plus placebo COPEGUS tablets),

or conventional interferon alfa-2a 3MIU three times a week in combination

with ribavirin 800mg daily, all for 48 weeks.

New data on quality of life from second landmark trial in patients with

normal ALT

A substantial proportion of hepatitis C patients have ‘normal’ levels of ALT

(an enzyme present in the blood used historically as a marker for liver

injury and disease). Because these levels are ‘normal’, these patients were

traditionally considered to have ‘mild’ hepatitis and therefore did not need

to be treated. More recently, however, there has been a growing awareness

that ALT is actually a poor marker of liver disease. Indeed, all patients in

this trial had evidence of liver inflammation and nearly one third had some

degree of fibrosis.

In the only global trial in this group of patients, 514 patients were

randomized to receive either PEGASYS 180µg once weekly plus COPEGUS 800mg

daily for either 24 or 48 weeks, followed by a 24-week treatment-free

follow-up period. A third arm was an untreated control group, since no

treatment was considered the standard of care at the time the study was

designed.

The key trial findings were:

• Overall 52% of hepatitis C patients with ‘normal’ ALT levels achieved an

SVR while none in the control arm did. These results are consistent with the

excellent results seen in other patient populations treated with PEGASYS

plus COPEGUS.

• 72% of PEGASYS patients infected with genotypes 2 or 3 who were treated

for 24 weeks and 40% of PEGASYS patients infected with the

‘difficult-to-treat’ genotype 1 who were treated for 48 weeks achieved an

SVR.

New data presented at EASL noted that:

• Those who achieved an SVR reported a better QoL including reduced fatigue

than both the untreated control group and those who failed to achieve an

SVR.

• Those patients who failed to achieve an EVR following 12 weeks of therapy

were highly unlikely to achieve an SVR. As in other HCV patient groups, this

provides an early and meaningful time point for physicians and patients to

discuss the benefits of continuing with treatment if viral eradication may

not be achieved.

“The results of this trial are very important because until now it was not

clear if there were benefits to treating these patients – which account for

about 30% of patients with chronic hepatitis C,” said Professor Stefan

Zeuzem, from Saarland University, Homburg, Germany. “Now, we know these

patients can be effectively treated like other patients with hepatitis C and

experience improvements in their quality of life.”

New trial underway by Roche in another difficult-to-treat group of patients

Recently Roche announced the launch of the first global trial to study the

efficacy of PEGASYS plus COPEGUS in another difficult-to-treat patient

population: hepatitis C patients who failed to respond to peginterferon

alfa-2b plus ribavirin combination therapy. This trial is known as REPEAT,

which stands for " Retreatment with PEGASYS in patients not responding to

prior peginterferon alfa-2b/ribavirin combination therapy " . The REPEAT study

will evaluate the efficacy and safety of the combination of PEGASYS and

COPEGUS given for a longer, 72-week period, as well as examining the role of

an induction regimen in this treatment- resistant population.

Close to 1,000 patients will participate in this study from Europe, North

America and Latin America.

About PEGASYS

PEGASYS, a new generation hepatitis C therapy that is different by design,

provides significant benefit over conventional interferon therapy in

patients infected with HBV and HCV. The benefits of PEGASYS are derived from

its new generation large 40 kilodalton (KD) branched-chain polyethylene

glycol (PEG) construction, which allows for sustained drug levels over the

course of a full week. PEGASYS also distributes more readily to the liver

(the primary site of infection) than conventional interferon. In HCV PEGASYS

provides superior efficacy compared to conventional interferon combination

therapy in HCV patients of all genotypes. PEGASYS is the only pegylated

interferon available as a ready-to-administer solution. Each weekly

subcutaneous injection contains 180mcg of pegylated interferon alfa-2a

(40KD) which is the approved dose for all patients, regardless of body

weight.

All trademarks used or mentioned in this release are legally protected.

Film footage is available for broadcast journalists from The NewsMarket at

www.thenewsmarket.com. Video is compressed in MPEG2 and is available for

download to your FTP server.

REFERENCES:

•Torriani FJ, Rockstroh J, - M, et al. Final week-72 results

of the AIDS Pegasys Ribavirin International Co-infection Trial (APRICOT): A

randomized, partially-blinded, multinational comparative trial of

peginterferon alfa-2a (40KD) (PEGASYS®) plus ribavirin (RBV) (COPEGUS®) vs

interferon alfa-2a (IFN) plus RBV in the treatment of HCV in HIV/HCV

co-infection. EASL oral presentation, 2004.

•M. -, Torriani FJ, Lissen E, et al. Early Prediction of

Sustained Virological Response (SVR) During Treatment with Peginterferon

Alfa-2a (40KD) (PEGASYS) Plus Ribavirin (RBV) (COPEGUS) In Patients With

HCV/HIV Co-infection: Results From The AIDS PEGASYS Ribavirin International

Co-Infection Trial (APRICOT) Study. EASL abstract, 2004.

•O’Brien C, Wintfeld N, Patel KK, et al. The impact of sustained virological

response (SVR) on health-related quality of life (HRQL) in patients with

chronic hepatitis C (CHC) and persistently normal ALT levels (PNALT) treated

with peginterferon alfa-2a (PEGASYS®) and ribavirin (COPEGUS®). EASL

abstract, 2004.

•Pockros PJ, Diago M, Gane E, et al. Early prediction of sustained

virological response (SVR) during treatment with peginterferon alfa-2a

(40KD) (PEGASYS®) plus ribavirin (RBV) (COPEGUS®) in patients with chronic

hepatitis C (CHC) and persistently normal alanine aminotransferase (ALT)

levels: Results of a multinational trial. EASL abstract, 2004.

[Guest guest]

http://www.hcvadvocate.org/news/newsRev/2004/NewsRev-44.html

PEGASYS and COPEGUS Now Offers Benefits in a Wider Range of Hepatitis C

Patients

Source: Roche Press Release

New Data Presented At European Liver Meeting On Two Multinational Trials

Basel, Switzerland –– New data from two pioneering hepatitis C (HCV) studies

with PEGASYS® plus COPEGUS® will be presented this week at the 39th Annual

Meeting of the European Association for the Study of the Liver (EASL) in

Berlin. The multinational trials – one in patients with HIV-HCV co-infection

and the other in HCV patients with persistently normal levels of alanine

aminotransferase (ALT) –demonstrate that PEGASYS plus COPEGUS is an

effective, safe and predictable treatment option.

Final results of APRICOT report highest ever treatment response in

co-infected patients

The final results of APRICOT (AIDS PEGASYS— Ribavirin International

CO-infection Trial) – the largest and only multinational study evaluating

the efficacy and safety of pegylated interferon combination therapy in

people co-infected with HIV and HCV – found that the combination of PEGASYS

and COPEGUS achieved a 40% sustained virological response (SVR) – the

highest ever reported in a trial of co-infected patients.

“APRICOT provides the guidance that we have wanted on how best to treat

co-infected patients and there is no doubt that the combination of PEGASYS

and COPEGUS represents the best we can currently offer this patient

population,” said Dr. Francesca Torriani, Associate Professor of Medicine,

Antiviral Research Centre, University of California at San Diego and one of

the APRICOT lead investigators. “What’s more, we now have data from this

trial on our ability to confidently predict as early as week 12 of therapy

which patients are likely to achieve a sustained virological response.”

The key APRICOT findings that Dr. Torriani will present on Sunday, April

18th are:

• 40% of patients treated with PEGASYS plus COPEGUS achieved an SVR compared

to 20% of patients treated with PEGASYS monotherapy and 12% of patients

treated with conventional interferon/ribavirin.

• Genotype 1 patients treated with PEGASYS plus COPEGUS achieved a four-fold

increase in SVR compared to conventional interferon/ribavirin (29% vs 7%).

• 62% of genotype 2/3 patients treated with PEGASYS plus COPEGUS combination

therapy achieved an SVR compared to 20% with conventional

interferon/ribavirin.

New APRICOT data identifies patients most likely to respond

New data will be presented on APRICOT that will help physicians identify

those patients with the best chance of achieving an SVR. 71% of co-infected

patients achieved an EVR following 12 weeks of a fixed 180µg/week dose of

PEGASYS and 800mg daily of COPEGUS (ribavirin), and of those, more than half

(56%) achieved an SVR. Among patients with the more difficult-to-treat HCV

genotype 1, 45% who had an EVR went on to achieve a sustained virological

response. The ability to tell patients at week 12 if their treatment is

likely to generate an SVR, is now recognized as having an important role in

the motivation of patients to start with, and stay on, therapy.

Real world patient population in APRICOT

The patients in this landmark study were predominantly male, middle-aged

with stable HIV disease. However, patients had a wide range of HIV status;

the majority were on anti-retroviral therapy and they had very high HCV

viral loads (10-15 million copies/ml). The very low (12%) response achieved

by patients to the arm receiving conventional interferon combination therapy

is illustrative of the challenging nature of the co-infection present in

these patients.

European Union contributes nearly half the patients

422 of the 868 patients randomized in APRICOT came from 11 European Union

countries – a total of 19 countries participated. These patients were

randomized to receive either PEGASYS 180µg once weekly plus COPEGUS 800mg

daily; PEGASYS 180µg monotherapy once weekly (plus placebo COPEGUS tablets),

or conventional interferon alfa-2a 3MIU three times a week in combination

with ribavirin 800mg daily, all for 48 weeks.

New data on quality of life from second landmark trial in patients with

normal ALT

A substantial proportion of hepatitis C patients have ‘normal’ levels of ALT

(an enzyme present in the blood used historically as a marker for liver

injury and disease). Because these levels are ‘normal’, these patients were

traditionally considered to have ‘mild’ hepatitis and therefore did not need

to be treated. More recently, however, there has been a growing awareness

that ALT is actually a poor marker of liver disease. Indeed, all patients in

this trial had evidence of liver inflammation and nearly one third had some

degree of fibrosis.

In the only global trial in this group of patients, 514 patients were

randomized to receive either PEGASYS 180µg once weekly plus COPEGUS 800mg

daily for either 24 or 48 weeks, followed by a 24-week treatment-free

follow-up period. A third arm was an untreated control group, since no

treatment was considered the standard of care at the time the study was

designed.

The key trial findings were:

• Overall 52% of hepatitis C patients with ‘normal’ ALT levels achieved an

SVR while none in the control arm did. These results are consistent with the

excellent results seen in other patient populations treated with PEGASYS

plus COPEGUS.

• 72% of PEGASYS patients infected with genotypes 2 or 3 who were treated

for 24 weeks and 40% of PEGASYS patients infected with the

‘difficult-to-treat’ genotype 1 who were treated for 48 weeks achieved an

SVR.

New data presented at EASL noted that:

• Those who achieved an SVR reported a better QoL including reduced fatigue

than both the untreated control group and those who failed to achieve an

SVR.

• Those patients who failed to achieve an EVR following 12 weeks of therapy

were highly unlikely to achieve an SVR. As in other HCV patient groups, this

provides an early and meaningful time point for physicians and patients to

discuss the benefits of continuing with treatment if viral eradication may

not be achieved.

“The results of this trial are very important because until now it was not

clear if there were benefits to treating these patients – which account for

about 30% of patients with chronic hepatitis C,” said Professor Stefan

Zeuzem, from Saarland University, Homburg, Germany. “Now, we know these

patients can be effectively treated like other patients with hepatitis C and

experience improvements in their quality of life.”

New trial underway by Roche in another difficult-to-treat group of patients

Recently Roche announced the launch of the first global trial to study the

efficacy of PEGASYS plus COPEGUS in another difficult-to-treat patient

population: hepatitis C patients who failed to respond to peginterferon

alfa-2b plus ribavirin combination therapy. This trial is known as REPEAT,

which stands for " Retreatment with PEGASYS in patients not responding to

prior peginterferon alfa-2b/ribavirin combination therapy " . The REPEAT study

will evaluate the efficacy and safety of the combination of PEGASYS and

COPEGUS given for a longer, 72-week period, as well as examining the role of

an induction regimen in this treatment- resistant population.

Close to 1,000 patients will participate in this study from Europe, North

America and Latin America.

About PEGASYS

PEGASYS, a new generation hepatitis C therapy that is different by design,

provides significant benefit over conventional interferon therapy in

patients infected with HBV and HCV. The benefits of PEGASYS are derived from

its new generation large 40 kilodalton (KD) branched-chain polyethylene

glycol (PEG) construction, which allows for sustained drug levels over the

course of a full week. PEGASYS also distributes more readily to the liver

(the primary site of infection) than conventional interferon. In HCV PEGASYS

provides superior efficacy compared to conventional interferon combination

therapy in HCV patients of all genotypes. PEGASYS is the only pegylated

interferon available as a ready-to-administer solution. Each weekly

subcutaneous injection contains 180mcg of pegylated interferon alfa-2a

(40KD) which is the approved dose for all patients, regardless of body

weight.

All trademarks used or mentioned in this release are legally protected.

Film footage is available for broadcast journalists from The NewsMarket at

www.thenewsmarket.com. Video is compressed in MPEG2 and is available for

download to your FTP server.

REFERENCES:

•Torriani FJ, Rockstroh J, - M, et al. Final week-72 results

of the AIDS Pegasys Ribavirin International Co-infection Trial (APRICOT): A

randomized, partially-blinded, multinational comparative trial of

peginterferon alfa-2a (40KD) (PEGASYS®) plus ribavirin (RBV) (COPEGUS®) vs

interferon alfa-2a (IFN) plus RBV in the treatment of HCV in HIV/HCV

co-infection. EASL oral presentation, 2004.

•M. -, Torriani FJ, Lissen E, et al. Early Prediction of

Sustained Virological Response (SVR) During Treatment with Peginterferon

Alfa-2a (40KD) (PEGASYS) Plus Ribavirin (RBV) (COPEGUS) In Patients With

HCV/HIV Co-infection: Results From The AIDS PEGASYS Ribavirin International

Co-Infection Trial (APRICOT) Study. EASL abstract, 2004.

•O’Brien C, Wintfeld N, Patel KK, et al. The impact of sustained virological

response (SVR) on health-related quality of life (HRQL) in patients with

chronic hepatitis C (CHC) and persistently normal ALT levels (PNALT) treated

with peginterferon alfa-2a (PEGASYS®) and ribavirin (COPEGUS®). EASL

abstract, 2004.

•Pockros PJ, Diago M, Gane E, et al. Early prediction of sustained

virological response (SVR) during treatment with peginterferon alfa-2a

(40KD) (PEGASYS®) plus ribavirin (RBV) (COPEGUS®) in patients with chronic

hepatitis C (CHC) and persistently normal alanine aminotransferase (ALT)

levels: Results of a multinational trial. EASL abstract, 2004.

[Guest guest]

http://www.hcvadvocate.org/news/newsRev/2004/NewsRev-44.html

PEGASYS and COPEGUS Now Offers Benefits in a Wider Range of Hepatitis C

Patients

Source: Roche Press Release

New Data Presented At European Liver Meeting On Two Multinational Trials

Basel, Switzerland –– New data from two pioneering hepatitis C (HCV) studies

with PEGASYS® plus COPEGUS® will be presented this week at the 39th Annual

Meeting of the European Association for the Study of the Liver (EASL) in

Berlin. The multinational trials – one in patients with HIV-HCV co-infection

and the other in HCV patients with persistently normal levels of alanine

aminotransferase (ALT) –demonstrate that PEGASYS plus COPEGUS is an

effective, safe and predictable treatment option.

Final results of APRICOT report highest ever treatment response in

co-infected patients

The final results of APRICOT (AIDS PEGASYS— Ribavirin International

CO-infection Trial) – the largest and only multinational study evaluating

the efficacy and safety of pegylated interferon combination therapy in

people co-infected with HIV and HCV – found that the combination of PEGASYS

and COPEGUS achieved a 40% sustained virological response (SVR) – the

highest ever reported in a trial of co-infected patients.

“APRICOT provides the guidance that we have wanted on how best to treat

co-infected patients and there is no doubt that the combination of PEGASYS

and COPEGUS represents the best we can currently offer this patient

population,” said Dr. Francesca Torriani, Associate Professor of Medicine,

Antiviral Research Centre, University of California at San Diego and one of

the APRICOT lead investigators. “What’s more, we now have data from this

trial on our ability to confidently predict as early as week 12 of therapy

which patients are likely to achieve a sustained virological response.”

The key APRICOT findings that Dr. Torriani will present on Sunday, April

18th are:

• 40% of patients treated with PEGASYS plus COPEGUS achieved an SVR compared

to 20% of patients treated with PEGASYS monotherapy and 12% of patients

treated with conventional interferon/ribavirin.

• Genotype 1 patients treated with PEGASYS plus COPEGUS achieved a four-fold

increase in SVR compared to conventional interferon/ribavirin (29% vs 7%).

• 62% of genotype 2/3 patients treated with PEGASYS plus COPEGUS combination

therapy achieved an SVR compared to 20% with conventional

interferon/ribavirin.

New APRICOT data identifies patients most likely to respond

New data will be presented on APRICOT that will help physicians identify

those patients with the best chance of achieving an SVR. 71% of co-infected

patients achieved an EVR following 12 weeks of a fixed 180µg/week dose of

PEGASYS and 800mg daily of COPEGUS (ribavirin), and of those, more than half

(56%) achieved an SVR. Among patients with the more difficult-to-treat HCV

genotype 1, 45% who had an EVR went on to achieve a sustained virological

response. The ability to tell patients at week 12 if their treatment is

likely to generate an SVR, is now recognized as having an important role in

the motivation of patients to start with, and stay on, therapy.

Real world patient population in APRICOT

The patients in this landmark study were predominantly male, middle-aged

with stable HIV disease. However, patients had a wide range of HIV status;

the majority were on anti-retroviral therapy and they had very high HCV

viral loads (10-15 million copies/ml). The very low (12%) response achieved

by patients to the arm receiving conventional interferon combination therapy

is illustrative of the challenging nature of the co-infection present in

these patients.

European Union contributes nearly half the patients

422 of the 868 patients randomized in APRICOT came from 11 European Union

countries – a total of 19 countries participated. These patients were

randomized to receive either PEGASYS 180µg once weekly plus COPEGUS 800mg

daily; PEGASYS 180µg monotherapy once weekly (plus placebo COPEGUS tablets),

or conventional interferon alfa-2a 3MIU three times a week in combination

with ribavirin 800mg daily, all for 48 weeks.

New data on quality of life from second landmark trial in patients with

normal ALT

A substantial proportion of hepatitis C patients have ‘normal’ levels of ALT

(an enzyme present in the blood used historically as a marker for liver

injury and disease). Because these levels are ‘normal’, these patients were

traditionally considered to have ‘mild’ hepatitis and therefore did not need

to be treated. More recently, however, there has been a growing awareness

that ALT is actually a poor marker of liver disease. Indeed, all patients in

this trial had evidence of liver inflammation and nearly one third had some

degree of fibrosis.

In the only global trial in this group of patients, 514 patients were

randomized to receive either PEGASYS 180µg once weekly plus COPEGUS 800mg

daily for either 24 or 48 weeks, followed by a 24-week treatment-free

follow-up period. A third arm was an untreated control group, since no

treatment was considered the standard of care at the time the study was

designed.

The key trial findings were:

• Overall 52% of hepatitis C patients with ‘normal’ ALT levels achieved an

SVR while none in the control arm did. These results are consistent with the

excellent results seen in other patient populations treated with PEGASYS

plus COPEGUS.

• 72% of PEGASYS patients infected with genotypes 2 or 3 who were treated

for 24 weeks and 40% of PEGASYS patients infected with the

‘difficult-to-treat’ genotype 1 who were treated for 48 weeks achieved an

SVR.

New data presented at EASL noted that:

• Those who achieved an SVR reported a better QoL including reduced fatigue

than both the untreated control group and those who failed to achieve an

SVR.

• Those patients who failed to achieve an EVR following 12 weeks of therapy

were highly unlikely to achieve an SVR. As in other HCV patient groups, this

provides an early and meaningful time point for physicians and patients to

discuss the benefits of continuing with treatment if viral eradication may

not be achieved.

“The results of this trial are very important because until now it was not

clear if there were benefits to treating these patients – which account for

about 30% of patients with chronic hepatitis C,” said Professor Stefan

Zeuzem, from Saarland University, Homburg, Germany. “Now, we know these

patients can be effectively treated like other patients with hepatitis C and

experience improvements in their quality of life.”

New trial underway by Roche in another difficult-to-treat group of patients

Recently Roche announced the launch of the first global trial to study the

efficacy of PEGASYS plus COPEGUS in another difficult-to-treat patient

population: hepatitis C patients who failed to respond to peginterferon

alfa-2b plus ribavirin combination therapy. This trial is known as REPEAT,

which stands for " Retreatment with PEGASYS in patients not responding to

prior peginterferon alfa-2b/ribavirin combination therapy " . The REPEAT study

will evaluate the efficacy and safety of the combination of PEGASYS and

COPEGUS given for a longer, 72-week period, as well as examining the role of

an induction regimen in this treatment- resistant population.

Close to 1,000 patients will participate in this study from Europe, North

America and Latin America.

About PEGASYS

PEGASYS, a new generation hepatitis C therapy that is different by design,

provides significant benefit over conventional interferon therapy in

patients infected with HBV and HCV. The benefits of PEGASYS are derived from

its new generation large 40 kilodalton (KD) branched-chain polyethylene

glycol (PEG) construction, which allows for sustained drug levels over the

course of a full week. PEGASYS also distributes more readily to the liver

(the primary site of infection) than conventional interferon. In HCV PEGASYS

provides superior efficacy compared to conventional interferon combination

therapy in HCV patients of all genotypes. PEGASYS is the only pegylated

interferon available as a ready-to-administer solution. Each weekly

subcutaneous injection contains 180mcg of pegylated interferon alfa-2a

(40KD) which is the approved dose for all patients, regardless of body

weight.

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REFERENCES:

•Torriani FJ, Rockstroh J, - M, et al. Final week-72 results

of the AIDS Pegasys Ribavirin International Co-infection Trial (APRICOT): A

randomized, partially-blinded, multinational comparative trial of

peginterferon alfa-2a (40KD) (PEGASYS®) plus ribavirin (RBV) (COPEGUS®) vs

interferon alfa-2a (IFN) plus RBV in the treatment of HCV in HIV/HCV

co-infection. EASL oral presentation, 2004.

•M. -, Torriani FJ, Lissen E, et al. Early Prediction of

Sustained Virological Response (SVR) During Treatment with Peginterferon

Alfa-2a (40KD) (PEGASYS) Plus Ribavirin (RBV) (COPEGUS) In Patients With

HCV/HIV Co-infection: Results From The AIDS PEGASYS Ribavirin International

Co-Infection Trial (APRICOT) Study. EASL abstract, 2004.

•O’Brien C, Wintfeld N, Patel KK, et al. The impact of sustained virological

response (SVR) on health-related quality of life (HRQL) in patients with

chronic hepatitis C (CHC) and persistently normal ALT levels (PNALT) treated

with peginterferon alfa-2a (PEGASYS®) and ribavirin (COPEGUS®). EASL

abstract, 2004.

•Pockros PJ, Diago M, Gane E, et al. Early prediction of sustained

virological response (SVR) during treatment with peginterferon alfa-2a

(40KD) (PEGASYS®) plus ribavirin (RBV) (COPEGUS®) in patients with chronic

hepatitis C (CHC) and persistently normal alanine aminotransferase (ALT)

levels: Results of a multinational trial. EASL abstract, 2004.