PEGASYS is the first and only FDA-approved treatment for HCV/HIV coinfected patients.
PEGASYS + COPEGUS® (Ribavirin, USP) performed with superior efficacy over interferon alfa-2a + ribavirin in the APRICOT* studythe largest-ever trial in HCV/HIV coinfected patients.1
Overall, 40% of patients treated with PEGASYS + COPEGUS achieved a sustained virologic response (SVR).1
The SVR rate for patients with genotype 1 who were treated with PEGASYS + COPEGUS was 29%more than 4 times higher than with interferon + ribavirin.1 Among patients taking 80% or more of their planned medication over the course of treatment, the response rate increased to 39%.2
The SVR response rate for patients treated with PEGASYS + COPEGUS was 62% for HCV genotypes 2 and 3more than 3 times higher than the response rate with interferon alfa-2a + ribavirin.1
- An overall SVR of 30% was observed in patients (13/44) with bridging fibrosis/cirrhosis who were treated with PEGASYS + COPEGUS.3
- The overall efficacy and safety of PEGASYS + COPEGUS was not adversely affected by baseline CD4 count in APRICOT, although the number of patients with CD4 <200 was small.†2
*APRICOT consisted of 860 HCV/HIV coinfected patients who randomly received either PEGASYS + COPEGUS, PEGASYS + placebo, or interferon alfa-2a + ribavirin for 48 weeks. Of these patients, 809 had ≥200 cells/mm regardless of HIV RNA levels and 51 had 100-199 cells/mm in HIV RNA <5000 copies/mL.
†Patient numbers (n=17) were very small and no firm conclusions can be drawn from this.
Treating patients with PEGASYS may result in a histologic response.4
In patients with paired biopsies:
- 87% of the patients overall and 95% of patients with bridging fibrosis/cirrhosis treated with PEGASYS + COPEGUS showed either a histologic response or remained stable.4,5
‡Histologic response was defined as ≥2-point reduction from baseline in the total histologic activity index (HAI) score. No change was defined as a change in HAI score of +1, -1, or 0; worsening was defined as an increase in HAI score of ≥2 points.
All paired biopsies were scored by local pathologists.
In patients without an SVR:
- 77% of overall HCV/HIV patients (47/61) achieved a histologic response or remained stable.5
- 58% of HCV/HIV patients (7/12) with bridging fibrosis/cirrhosis achieved a histologic response.4
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