Fwd: [NATAP] Infergen+IFN-gamma in Nonresponders: 48 wks results

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Subject: [NATAP] Infergen+IFN-gamma in Nonresponders: 48 wks results

NATAP - www.natap.org

IFN Alfacon (Infergen) + IFN-gamma in Nonresponders: 48 week results

Reported by Jules Levin

Carroll Leevy reported these pilot study results at AASLD (October 2004).

Preclinical studies have demonstrated strong synergistic antiviral and

immunomodulatory effects of the combination of IFN alfacon 1 (consensus

interferon; Infergen) and IFN-gamma 1b (Actimmune) in preclinical models of HCV.

Researchers conducted a retrospective analysis of 50 Null Responders to

pegylated IFN alfa 2a + ribavirin therapy who were retreated with IFN alfacon 1,

15 mcg SQ daily, and IFN-gamma 1b 50 mcg SQ TIW for 48 weeks.

All patients had previously received pegylated interferon alfa 2a (Pegasys) and

ribavirin for 12 weeks, and did not have at least a 2- log10 drop in HCV RNA.

Serum HCV RNA was assessed at weeks 8, 12, 24, and 48 weeks to determine early

virologic response and will be assessed at weeks 48 and 72 to determine end of

treatment and sustained virologic responses.

Patients were monitored for constitutional symptoms and bloods were collected

for serum chemistries and hematological evaluations.

This retrospective case series examined the safety and efficacy of re-treating

patients who did not respond to peg-IFN-a-2+RBV therapy with a combination of a

bio-engineered type 1 IFN (IFN alfacon-1) and a recombinant type 2 IFN

(IFN-gamma 1b). IFN-gamma and IFN alfacon-1 display synergistic antiviral

activity when combined (Blatt et al AASLD 2003).

PATIENT CHARACTERISTICS: 26 men; age: 43 yrs; fibrosis stage (Ishak) 0-1: 11

patients, 2-4: 39 patients; HCV genotypes 1 & 4: 45 patients, other 5 patients;

weight: mean 79 kg.

SELECTED BASELINE LABS

ALT: 51 IU/mL

AST: 62 IU/mL

Hemoglobin: 11.5 g/dL

Platelets: 201,700 mm3

Serum HCV RNA: 3.27 million copies/ml

EFFICACY

After 8, 12, 24, and 48 weeks treatment, rates of HCV negativity were 36%, 40%,

46%, and 44%, respectively. For genotype 1 patients, the rates of HCV RNA

negativity were 36%, 39%, 44%, and 48%, respectively.

By week 8, all patients hemoglobin levels had returned to normal without the use

of EPO, indicating that IFN alfacon & IFN-gamma does not interfere with

hemoglobin recovery. By week 24, 11 patients required filgastim for neutropenia.

Average serum ALT was between 20-30 IU/mL at week 24.

Patients continue to be treated & assessed. A phase II dose0finding study in

nonresponders is underway.

_______________________________________________

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[Guest guest]

hcv@... wrote: Date: Mon, 22 Nov 2004 17:10:40 EST

hcv@..., hcvhiv@..., doctors@..., misc@...,

europe@..., industry@...

CC:

From: hcv@...

Subject: [NATAP] Infergen+IFN-gamma in Nonresponders: 48 wks results

NATAP - www.natap.org

IFN Alfacon (Infergen) + IFN-gamma in Nonresponders: 48 week results

Reported by Jules Levin

Carroll Leevy reported these pilot study results at AASLD (October 2004).

Preclinical studies have demonstrated strong synergistic antiviral and

immunomodulatory effects of the combination of IFN alfacon 1 (consensus

interferon; Infergen) and IFN-gamma 1b (Actimmune) in preclinical models of HCV.

Researchers conducted a retrospective analysis of 50 Null Responders to

pegylated IFN alfa 2a + ribavirin therapy who were retreated with IFN alfacon 1,

15 mcg SQ daily, and IFN-gamma 1b 50 mcg SQ TIW for 48 weeks.

All patients had previously received pegylated interferon alfa 2a (Pegasys) and

ribavirin for 12 weeks, and did not have at least a 2- log10 drop in HCV RNA.

Serum HCV RNA was assessed at weeks 8, 12, 24, and 48 weeks to determine early

virologic response and will be assessed at weeks 48 and 72 to determine end of

treatment and sustained virologic responses.

Patients were monitored for constitutional symptoms and bloods were collected

for serum chemistries and hematological evaluations.

This retrospective case series examined the safety and efficacy of re-treating

patients who did not respond to peg-IFN-a-2+RBV therapy with a combination of a

bio-engineered type 1 IFN (IFN alfacon-1) and a recombinant type 2 IFN

(IFN-gamma 1b). IFN-gamma and IFN alfacon-1 display synergistic antiviral

activity when combined (Blatt et al AASLD 2003).

PATIENT CHARACTERISTICS: 26 men; age: 43 yrs; fibrosis stage (Ishak) 0-1: 11

patients, 2-4: 39 patients; HCV genotypes 1 & 4: 45 patients, other 5 patients;

weight: mean 79 kg.

SELECTED BASELINE LABS

ALT: 51 IU/mL

AST: 62 IU/mL

Hemoglobin: 11.5 g/dL

Platelets: 201,700 mm3

Serum HCV RNA: 3.27 million copies/ml

EFFICACY

After 8, 12, 24, and 48 weeks treatment, rates of HCV negativity were 36%, 40%,

46%, and 44%, respectively. For genotype 1 patients, the rates of HCV RNA

negativity were 36%, 39%, 44%, and 48%, respectively.

By week 8, all patients hemoglobin levels had returned to normal without the use

of EPO, indicating that IFN alfacon & IFN-gamma does not interfere with

hemoglobin recovery. By week 24, 11 patients required filgastim for neutropenia.

Average serum ALT was between 20-30 IU/mL at week 24.

Patients continue to be treated & assessed. A phase II dose0finding study in

nonresponders is underway.

_______________________________________________

hcv mailing list

hcv@...

http://natap.org/mailman/listinfo/hcv_natap.org

[Guest guest]

hcv@... wrote: Date: Mon, 22 Nov 2004 17:10:40 EST

hcv@..., hcvhiv@..., doctors@..., misc@...,

europe@..., industry@...

CC:

From: hcv@...

Subject: [NATAP] Infergen+IFN-gamma in Nonresponders: 48 wks results

NATAP - www.natap.org

IFN Alfacon (Infergen) + IFN-gamma in Nonresponders: 48 week results

Reported by Jules Levin

Carroll Leevy reported these pilot study results at AASLD (October 2004).

Preclinical studies have demonstrated strong synergistic antiviral and

immunomodulatory effects of the combination of IFN alfacon 1 (consensus

interferon; Infergen) and IFN-gamma 1b (Actimmune) in preclinical models of HCV.

Researchers conducted a retrospective analysis of 50 Null Responders to

pegylated IFN alfa 2a + ribavirin therapy who were retreated with IFN alfacon 1,

15 mcg SQ daily, and IFN-gamma 1b 50 mcg SQ TIW for 48 weeks.

All patients had previously received pegylated interferon alfa 2a (Pegasys) and

ribavirin for 12 weeks, and did not have at least a 2- log10 drop in HCV RNA.

Serum HCV RNA was assessed at weeks 8, 12, 24, and 48 weeks to determine early

virologic response and will be assessed at weeks 48 and 72 to determine end of

treatment and sustained virologic responses.

Patients were monitored for constitutional symptoms and bloods were collected

for serum chemistries and hematological evaluations.

This retrospective case series examined the safety and efficacy of re-treating

patients who did not respond to peg-IFN-a-2+RBV therapy with a combination of a

bio-engineered type 1 IFN (IFN alfacon-1) and a recombinant type 2 IFN

(IFN-gamma 1b). IFN-gamma and IFN alfacon-1 display synergistic antiviral

activity when combined (Blatt et al AASLD 2003).

PATIENT CHARACTERISTICS: 26 men; age: 43 yrs; fibrosis stage (Ishak) 0-1: 11

patients, 2-4: 39 patients; HCV genotypes 1 & 4: 45 patients, other 5 patients;

weight: mean 79 kg.

SELECTED BASELINE LABS

ALT: 51 IU/mL

AST: 62 IU/mL

Hemoglobin: 11.5 g/dL

Platelets: 201,700 mm3

Serum HCV RNA: 3.27 million copies/ml

EFFICACY

After 8, 12, 24, and 48 weeks treatment, rates of HCV negativity were 36%, 40%,

46%, and 44%, respectively. For genotype 1 patients, the rates of HCV RNA

negativity were 36%, 39%, 44%, and 48%, respectively.

By week 8, all patients hemoglobin levels had returned to normal without the use

of EPO, indicating that IFN alfacon & IFN-gamma does not interfere with

hemoglobin recovery. By week 24, 11 patients required filgastim for neutropenia.

Average serum ALT was between 20-30 IU/mL at week 24.

Patients continue to be treated & assessed. A phase II dose0finding study in

nonresponders is underway.

_______________________________________________

hcv mailing list

hcv@...

http://natap.org/mailman/listinfo/hcv_natap.org

[Guest guest]

hcv@... wrote: Date: Mon, 22 Nov 2004 17:10:40 EST

hcv@..., hcvhiv@..., doctors@..., misc@...,

europe@..., industry@...

CC:

From: hcv@...

Subject: [NATAP] Infergen+IFN-gamma in Nonresponders: 48 wks results

NATAP - www.natap.org

IFN Alfacon (Infergen) + IFN-gamma in Nonresponders: 48 week results

Reported by Jules Levin

Carroll Leevy reported these pilot study results at AASLD (October 2004).

Preclinical studies have demonstrated strong synergistic antiviral and

immunomodulatory effects of the combination of IFN alfacon 1 (consensus

interferon; Infergen) and IFN-gamma 1b (Actimmune) in preclinical models of HCV.

Researchers conducted a retrospective analysis of 50 Null Responders to

pegylated IFN alfa 2a + ribavirin therapy who were retreated with IFN alfacon 1,

15 mcg SQ daily, and IFN-gamma 1b 50 mcg SQ TIW for 48 weeks.

All patients had previously received pegylated interferon alfa 2a (Pegasys) and

ribavirin for 12 weeks, and did not have at least a 2- log10 drop in HCV RNA.

Serum HCV RNA was assessed at weeks 8, 12, 24, and 48 weeks to determine early

virologic response and will be assessed at weeks 48 and 72 to determine end of

treatment and sustained virologic responses.

Patients were monitored for constitutional symptoms and bloods were collected

for serum chemistries and hematological evaluations.

This retrospective case series examined the safety and efficacy of re-treating

patients who did not respond to peg-IFN-a-2+RBV therapy with a combination of a

bio-engineered type 1 IFN (IFN alfacon-1) and a recombinant type 2 IFN

(IFN-gamma 1b). IFN-gamma and IFN alfacon-1 display synergistic antiviral

activity when combined (Blatt et al AASLD 2003).

PATIENT CHARACTERISTICS: 26 men; age: 43 yrs; fibrosis stage (Ishak) 0-1: 11

patients, 2-4: 39 patients; HCV genotypes 1 & 4: 45 patients, other 5 patients;

weight: mean 79 kg.

SELECTED BASELINE LABS

ALT: 51 IU/mL

AST: 62 IU/mL

Hemoglobin: 11.5 g/dL

Platelets: 201,700 mm3

Serum HCV RNA: 3.27 million copies/ml

EFFICACY

After 8, 12, 24, and 48 weeks treatment, rates of HCV negativity were 36%, 40%,

46%, and 44%, respectively. For genotype 1 patients, the rates of HCV RNA

negativity were 36%, 39%, 44%, and 48%, respectively.

By week 8, all patients hemoglobin levels had returned to normal without the use

of EPO, indicating that IFN alfacon & IFN-gamma does not interfere with

hemoglobin recovery. By week 24, 11 patients required filgastim for neutropenia.

Average serum ALT was between 20-30 IU/mL at week 24.

Patients continue to be treated & assessed. A phase II dose0finding study in

nonresponders is underway.

_______________________________________________

hcv mailing list

hcv@...

http://natap.org/mailman/listinfo/hcv_natap.org