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Boceprevir regimen led to high rates of undetectable HCV RNA in HCV/HIV

Issue: April 2012

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SEATTLE — A boceprevir plus pegylated interferon and ribavirin combination resulted in significantly high rates of undetectable hepatitis C virus RNA at weeks 4, 8, 12, 24 and 48 in patients coinfected with hepatitis C virus genotype-1 and HIV.

“The [sustained virological response] 12 data being presented today is an endpoint that is currently being determined by regulatory authorities to represent a solid sustained virologic response metric,” Mark Sulkowski, MD, of Johns Hopkins University School of Medicine, said during the meeting. “Our data suggest that boceprevir plus pegylated interferon and ribavirin had a sustained virologic response rate of 60.7%, with three patients negative at 4 weeks.”

From November 2009 to December 2010, patients were randomly assigned in a 2:1 fashion to 1.5 mcg/week pegylated interferon plus 600 mg/day to 1,400 mg/day ribavirin and 800 mg boceprevir (Victrelis, Merck) three-times daily (n=64) or to placebo plus pegylated interferon and ribavirin (n=34). The median age of the patients was 43 years; 69% male, and 82% white.

Treatment duration was 44 weeks. Primary outcome measure was an achievement of SVR (undetectable plasma HCV RNA) by week 24 of treatment.

Overall, 61% of patients assigned to the boceprevir arm completed treatment vs. 32% of those assigned placebo by week 48. Compared with an undetectable HCV RNA rate of 29.4% in the placebo arm, the rate was 63.9% in the boceprevir arm.

Treatment failure occurred in 9% of those assigned boceprevir vs. 53% of those assigned placebo. Patients included in the boceprevir arm were more likely to experience adverse events, including a decreased appetite, anemia and neutropenia. HIV RNA virologic failure occurred in two patients in the placebo arm and in three patients in the boceprevir arm.

“Our data suggest that the boceprevir regimen was well tolerated in these patients with HCV/HIV coinfection,” Sulkowski said.

For more information:

• Sulkowski M. #47. Presented at: 19th Conference on Retroviruses and Opportunistic Infections; March 5-8, 2012; Seattle.

Disclosure: The researchers report no relevant financial disclosures.

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