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03/04/2013

CROI 2013: Triple therapy for HCV co-infected patients who failed dual therapy


Either of the currently licensed HCV protease inhibitors (PI), telaprevir and boceprevir, when combined with pegylated interferon-IFN plus ribavirin (peg-IFN/RBV) can produce an sustained virologic response (SVR) in HCV mono-infected patients who previously failed dual therapy without an HCV PI.

Many HIV-HCV co-infected patients have failed dual therapy because their responses to pegIFN/RBV are poorer than those with HCV mono-infection. However, no studies have yet addressed management of this coinfected patient group. Interim analysis of two studies being conducted in France were reported at CROI 2013 [1,2]. Patients were HIV co-infected with genotype 1 HCV and had previous viral failure after at least 12 weeks of peg-IFN/RBV. One study utilized telaprevir and the other boceprevir, but the designs were otherwise similar.

In the telaprevir trial, week 16 on treatment results showed 88% had HV RNA <15 IU/ml, with results varying little based on pattern of prior response to dual therapy. In the boceprevir study, 63% were <15 IU/ml at week 16 with prior relapsers doing better (90%) than null responders (38%). Patients on a raltegravir-based ART regimen also appeared to do somewhat better than those on atazanavir/ritonavir. In the US, administration of boceprevir and atazanavir is not recommended due to drug-drug interactions.

Stage of hepatic fibrosis at baseline did not appear to affect the response in either study. The duration of therapy in both studies will be 48 or 72 weeks for those with a complete or partial response at week 8, respectively. No data on SVR rates was available for this presentation. Adverse effects were numerous and typical of those described in mono-infected patients or co-infected treatment-naive patients given these agents.

These high rates of on-treatment viral suppression are very encouraging but very preliminary. Final results of these trials, including SVR rates, will establish if re-treatment using HCV PI-based triple therapy is warranted in co-infected patients with prior dual therapy failure.

References:
1. Cotte L, Braun J, Lascoux-Combe C, et al. High Early Virological Response with Telaprevir-Pegylated-Interferon-Ribavirin in Treatment-experienced Hepatitis C Virus Genotype 1/HIV Co-infected Patients: ANRS HC26 TelapreVIH Study. Presented March 4, 2013 at the 20th CROI, Atlanta Georgia. Oral Abstract 36; http://www.retroconference.org/2013b/Abstracts/46245.htm; http://www.retroconference.org/2013b/Abstracts/46245.htm
2. Poizot-Martin I, Bellissant E, Piroth L, et al. ANRS-HC27 BocepreVIH interim analysis: high early virologic response with boceprevir + pegylated interferon + ribivirin in hepatitis C virus/HIV co-infected patients with previous failure to pegylated interferon + ribivirin. Presented March 4, 2013 at the 20th CROI, Atlanta Georgia. Oral Abstract 37; http://www.retroconference.org/2013b/Abstracts/46522.htm


Source: Reporting from Atlanta for PRN News: David H. Shepp, MD