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Boceprevir safe, effective in HCV/HIV coinfection
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BOSTON — Results from a phase 2 trial demonstrate that adding boceprevir to peginterferon and ribavirin increased undetectable HCV RNA and was safe and well tolerated in patients coinfected with HCV and HIV.
Mark Sulkowski, MD, associate professor of medicine and medical director of the Viral Hepatitis Center in the Divisions of Infectious Diseases and Gastroenterology/Hepatology at Johns Hopkins University School of Medicine, and colleagues conducted a randomized study between November 2009 and December 2010 to determine the safety and efficacy of boceprevir plus peginterferon and ribavirin in this patient population.
The study included 98 patients with HCV genotype-1 and HIV RNA <50 copies/mL who were randomly assigned in a 1:2 fashion to control (experimental arms) and stratified by cirrhosis and baseline HCV-RNA <800,000 IU/mL vs. =800,000 IU/mL. Patients were randomly assigned to peginterferon at 1.5 ug/kg/week and ribavirin at 600 to 1,400 mg/day according to weight, plus boceprevir 800 mg twice daily (n=34) or peginterferon and ribavirin plus placebo (n=64) for 44 weeks. Some antiretroviral regimens were excluded, including NNRTIs, unboosted protease inhibitors, zidovudine and didanosine. All patients had a 4-week lead-in of peginterferon and ribavirin.
Most patients (95%) were non-cirrhotic, white (82%), male (69%) at a median age of about 43 years; most had high HCV RNA (88%) and HCV genotype-1a (65%). The rate of undetectable HCV RNA was 22.8% higher in the experimental arm compared with control at 8 weeks and 33.5% higher at 12 weeks. Adverse events resulted in treatment discontinuation in 14% of patients in the experimental arm and 9% of those in the control arm. Dysgeusia, vomiting, anoxrexia and neutropenia were more common in the experimental arm compared with control; the rate of anemia was similar between the groups.
There were no significant differences in CD4 count or percentage of patients with HIV RNA <50 copies/mL between the two groups at 12 weeks.
“The safety and tolerability profile was similar to that observed in HCV monoinfected patients,” Sulkowski and colleagues wrote. “These preliminary data support further studies of boceprevir plus peginterferon and ribavirin for the treatment of HCV and HIV-infected patients.” - by Stacey L. Fisher
For more information:
- Sulkowski M. LB-37. Presented at: IDSA 49th Annual Meeting; Oct. 20-23, 2011; Boston.
Disclosure: Dr. Sulkowski is an investigator and scientific advisor and receives a consulting fee and research support from Merck, Vertex, Abbott, BMS, BIPI, Tibotec, Pharmasset, Novartis and Roche/Genentech.
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