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,
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.