*1000 mg for body weight <75 kg; 1200 mg for body weight ≥75 kg.

Other Treatment Response Predictors

Treatment response rates are lower in patients with poor prognostic factors receiving pegylated interferon alpha therapy. In studies 4 and 5, treatment response rates were lower in patients older than 40 years (50% vs. 66%), in patients with cirrhosis (47% vs. 59%), in patients weighing over 85 kg (49% vs. 60%), and in patients with genotype 1 with high vs. low viral load (43% vs. 56%). African-American patients had lower response rates compared to Caucasians.

Paired liver biopsies were performed on approximately 20% of patients in studies 4 and 5. Modest reductions in inflammation compared to baseline were seen in all treatment groups.

In studies 4 and 5, lack of early virologic response by 12 weeks (defined as HCV RNA undetectable or >2log₁₀ lower than baseline) was grounds for discontinuation of treatment. Of patients who lacked an early viral response by 12 weeks and completed a recommended course of therapy despite a protocol-defined option to discontinue therapy, 5/39 (13%) achieved an SVR. Of patients who lacked an early viral response by 24 weeks, 19 complete a full course of therapy and none achieved an SVR.

Chronic Hepatitis C and Coinfection with HIV (CHC/HIV) Study 6: PEGASYS Monothe rapy and PEGASYS/COPEGUS Combination Therapy

In Study 6, patients with CHC/HIV were randomized to receive either PEGASYS 180 mg sc once weekly (qw) plus an oral placebo, PEGASYS 180 mg qw plus COPEGUS 800 mg po daily or ROFERON-A (interferon alfa-2a), 3 MIU sc tiw plus COPEGUS 800 mg po daily. All patients received 48 weeks of therapy and sustained virologic response (SVR) was assessed at 24 weeks of treatment-free follow-up. COPEGUS or placebo treatment assignment was blinded in the PEGASYS treatment arms. All patients were adults, had compensated liver disease, detectable hepatitis C virus, liver biopsy diagnosis of chronic hepatitis C, and were previously untreated with interferon. Patients also had CD4+ cell count ≥200 cells/mL or CD4+ cell count ≥100 cells/mL but <200 cells/γ¯µL and HIV-1 RNA <5000 copies/mL, and stable status of HIV. Approximately 15% of patients in the study had cirrhosis. Results are shown in Table 4.

*PEGASYS + COPEGUS vs. PEGASYS; PEGASYS + COPEGUS vs. ROFERON-A +

COPEGUS p- value <0.0001 (Cochran-Mantel-Haenszel).

Treatment response rates are lower in CHC/HIV patients with poor prognostic factors (including HCV genotype 1, HCV RNA >800,000 IU/mL, and cirrhosis) receiving pegylated interferon alpha therapy. Geographic region is not a prognostic factor for response. However, poor prognostic factors occur more frequently in the US population than in the non-US population.

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