• About PEGASYS + COPEGUS Combination Therapy
• The Benefits of Treatment
• PEGASYS Dosing
• Efficacy Across the Broadest Range of Patients
• Efficacy for Patients With HCV/HIV Coinfection
• Efficacy for Patients With Hepatitis B
• Safety and Tolerability
• Patient Support
• Resource Library
• Healthcare Professional Tools
• Guide to PEGASYS Prefilled Syringes

Starting your patients on appropriate therapy now may give them their best chance for success. Clearly, fibrosis progresses at different rates for different patients. But it is difficult to determine the rate of progression for an individual patient,¹ and, as we know, no test can tell the whole story. For example, approximately 60% of people with chronic hepatitis C do have elevated ALT levels.²

Clinical evidence shows that treating before liver damage progresses, may result in higher sustained virologic response (SVR) rates. Consider:

• Treatment with PEGASYS early in fibrosis stage may result in SVR rates as high as 57%.³

PEGASYS, alone or in combination with COPEGUS^® (Ribavirin, USP), is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (eg, antiretroviral therapy not required or receiving stable antiretroviral therapy). PEGASYS is indicated for the treatment of adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.

A greater number of genotype 1 patients with mild fibrosis achieved an SVR than those with cirrhosis.³

• Based on a retrospective analysis consisting of genotype 1 patients treated with PEGASYS (180 µg qw) and ribavirin (1000/1200 mg qd) for 48 weeks

Treatment With PEGASYS Can Result in Histologic Improvement.

Results from 2 pivotal trials demonstrated that PEGASYS use may result in a histologic response^*:

• In one study, the percentage of patients with a histologic response ranged from 72% to 78% for all treatment groups (194/260).^†4
• In another study, 80% of patients with paired biopsies (64/80) treated with PEGASYS + COPEGUS^® (Ribavirin, USP) for 48 weeks experienced a modest histologic response.⁴

^*Histologic improvement is defined as a change of ≥2 points in the histologic activity index (HAI) score.

^†Treatment groups received PEGASYS 180 µg qw for 24 or 48 weeks plus a low dose (800 mg qd) ribavirin or standard weight-based dose (1000/1200 mg qd) of ribavirin.

Treating Younger Patients With PEGASYS May Result in Higher SVR Rates.

• The patient's age at the time you initiate treatment can directly impact the probability of achieving an SVR. For every 10 years that a hepatitis C patient receives no PEGASYS treatment, the estimated response rate may decrease an average of 7%-9%.⁵

The patient's age at which you initiate treatment can directly impact the probability of achieving an SVR.

A logistic regression model based on a retrospective analysis consisting of 736 genotype 1 Caucasian patients with no cirrhosis. Patients received PEGASYS and ribavirin for 48 weeks.

High SVR Rates Achieved by Patients Who Completed Therapy With PEGASYS + Full-dose COPEGUS

Patients who were able to take between 80% and 97% of their COPEGUS dose achieved an SVR rate of 56%. That SVR rate increased to 66% when patients took >97% of their COPEGUS dose.⁷

Based on a retrospective analysis involving 569 genotype 1 patients treated with PEGASYS + COPEGUS (1000/1200 mg qd) for 48 weeks. SVR at COPEGUS cumulative dose levels regardless of PEGASYS reductions.

Early Treatment for HCV/HIV Coinfection

In the highly active antiretroviral therapy (HAART) era, end-stage liver disease (ESLD)⁸ has become the #1 cause of death in patients with HCV/HIV coinfection. Liver disease in coinfected patients progresses rapidly and unpredictably.^9-11 This underscores the need to evaluate all eligible coinfected patients for hepatitis C treatment.

Due to the effectiveness of HAART, more patients are dying from end-stage liver disease.^12,13

• In one retrospective study, among patients dying from ESLD in the HAART era, 94% tested positive for HCV antibodies, while more than half (55%) had CD4+ cell counts >200 cells/mm³ or undetectable HIV RNA.¹³

HCV/HIV Coinfected Patients Progress to ESLD More Quickly Than HCV Monoinfected Patients.

• Progression to cirrhosis occurs 3 times faster in HCV/HIV coinfected patients.¹⁰
• There is a 6-fold greater risk of decompensated liver disease occurring in HCV/HIV coinfected patients compared with HCV monoinfected patients.¹⁰

It is difficult to determine who is at risk for serious liver damage.¹⁴

• In a recent study, 25% of HCV/HIV coinfected patients (N=67) progressed from mild to significant fibrosis in less than 3 years.⁹

The CDC recommends that antiviral hepatitis C treatment should be considered for all HIV patients coinfected with chronic hepatitis C infection.¹⁵

1. Poynard T et al. Effects of interferon therapy in "non responder" patients with chronic hepatitis C. J Hepatol. 1999;31(suppl 1):178-183.
2. Pradat P, Alberti A, Poynard T et al. Predictive value of ALT levels for histologic findings in chronic hepatitis C: a European collaborative study. Hepatology. 2002;36(4 Pt I):973-977.
3. Shiffman ML et al. Peginterferon alfa 2a/RBV treatment of patients with HCV genotype 1: efficacy and safety in patients with early stage fibrosis. Gastroenterology. 2005;128(suppl 2):A722.
4. FDA Briefing Paper. Antiviral Drugs Advisory Committee Proceedings. Peginterferon alfa-2a. November 14, 2002.
5. Foster GR et al. Treatment of chronic hepatitis C peginterferon alfa-2a (40KD) (PEGASYS^®) and ribavirin (COPEGUS^®): patient age has a marked influence on the individual estimated probability of achieving a sustained virological response. Presented at: 54th Annual Meeting of the American Association for the Study of Liver Diseases; October 24-28, 2003; Boston, Mass.
6. Foster GR et al. Treatment of chronic hepatitis C peginterferon alfa-2a (40KD) (PEGASYS^®) and ribavirin (COPEGUS^®): patient age has a marked influence on the individual estimated probability of achieving a sustained virological response. Hepatol. 2003;37(suppl 1):246A.
7. Lee JS et al. Ribavirin (RBV) dose reduction in patients with HCV genotype 1 infection receiving combination treatment with peginterferon alfa-2a (40KD) (PEGASYS^®) and RBV (COPEGUS^®). Presented at: 55th Annual Meeting of the American Association for the Study of Liver Diseases; October 29-November 2, 2004; Boston, Mass.
8. Salmon-Ceron D et al. Liver disease as a major cause of death among HIV infected patients: role of hepatitis C and B viruses and alcohol. J Hepatol. 2005;42:799-805.
9. Sulkowski M et al. Unexpected significant liver disease among HIV/HCV coinfected persons with minimal fibrosis on initial liver biopsy. Presented at: 12th Conference on Retroviruses and Opportunistic Infections; February 22-25, 2005; Boston, Mass.
10. Graham CS et al. Influence of human immunodeficiency virus infection on the course of hepatitis C virus infection: a meta-analysis. Clin Infect Dis. 2001;33:562-569.
11. Soto B et al. Human immunodeficiency virus infection modifies the natural history of chronic parenterally-acquired hepatitis C with an unusually rapid progression to cirrhosis. J Hepatol. 1997;26:1-5.
12. Martinez-Sierra C et al. Progression of chronic hepatitis C to liver fibrosis and cirrhosis in patients coinfected with hepatitis C virus and human immunodeficiency virus. Clin Infect Dis. 2003;36:491-498.
13. Bica I et al. Increasing mortality due to end-stage liver disease in patients with human immunodeficiency virus infection. Clin Infect Dis. 2001;32:492-497.
14. Marcellin P et al. Fibrosis and disease progression in hepatitis C. Hepatology. 2002;36-S47-S56.
15. Centers for Disease Control and Prevention. National hepatitis C prevention strategy: hepatitis C infection in the United States. Available at: http://www.cdc.gov/ncidod/diseases/hepatitis/c/plan/HCV_infection.htm. Accessed November 1, 2005.