Article : Telaprevir for Genotype 1 Hepatitis C...

Telaprevir for Genotype 1 Hepatitis C in HIV-Coinfected Patients

In a small phase II study of telaprevir versus placebo in combination with standard HCV therapy, SVR rates were higher among telaprevir recipients, with no detrimental effects on HIV control.


Hepatitis C virus (HCV) therapy is notorious for toxicity and poor cure rates. In HIV/HCV-coinfected patients, sustained virologic response (SVR) rates with peginterferon and ribavirin (PEG-IFN/RBV) alone are abysmal, especially for genotype 1 HCV. Adding telaprevir (TVR) or boceprevir to PEG-IFN/RBV boosts SVR rates in patients monoinfected with genotype 1 HCV and is now standard of care; however, few data exist on use of this approach in HIV/HCV-coinfected patients.

In a recent industry-sponsored, phase IIa, double-blind, multinational study, investigators randomized 60 HIV-infected, HCV treatment–naive adults with genotype 1 HCV (88% men; 85% with baseline HCV RNA 800,000 IU/mL) to receive either TVR or placebo, each in combination with PEG-IFN/RBV, for the first 12 weeks of treatment; PEG-IFN/RBV was continued thereafter for an additional 36 weeks. Participants were required to have stable HIV disease on no antiretroviral therapy (ART) or well-controlled disease on an efavirenz- or boosted atazanavir–containing regimen.

Thirty-five participants (58%) completed 48 weeks of treatment. During the first 12 weeks, TVR recipients were more likely to experience side effects, which were mostly mild to moderate; serious adverse events were uncommon overall (5% with TVR vs. 0% with placebo). Incidence of rash was higher in the TVR arm than in the placebo arm (29% vs. 18%); however, no rash was serious or life-threatening. Participants in the TVR arm were more likely than those in the placebo arm to have undetectable HCV RNA at treatment weeks 4 (68% vs. 0%) and 12 (79% vs. 27%) and to have SVR at posttreatment weeks 12 and 24 (74% vs. 45%). Among participants taking ART, no HIV breakthroughs occurred, and ART exposure was not significantly affected by TVR.


CITATION(S):

Sulkowski MS et al. Combination therapy with telaprevir for chronic hepatitis C virus genotype 1 infection in patients with HIV: A randomized trial. Ann Intern Med 2013 May 17; [e-pub ahead of print]. 

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