Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination with Ribavirin and Daclatasvir for Treatment of Chronic HCV Infection with Treatment Naïve Genotypes 1, 2, 3 or 4 in Subjects Coinfected with HIV-1

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Investigator: Anne Luetkemeyer, MD
Sponsor: Bristol-Myers Squibb Company

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Location(s): United States

Description

To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1

Primary Outcome Measures:
  • Antiviral activity, as determined by the proportion of subjects with SVR12, defined as HCV RNA <LLOQ (25 IU/mL), target detected or target not detected, for each treatment arm [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Proportion of subjects with Rapid virologic response (RVR) and Extended Rapid Virologic Response (eRVR), where RVR is defined as <LLOQ target not detected at week 4 and eRVR defined as <LLOQ target not detected at Weeks 4 and 12 [ Time Frame: RVR at Week 4 and eRVR at Weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects in each group/duration who achieve HCV RNA <LLOQ target detected or not detected, at end of therapy (SVR24) [ Time Frame: 24 weeks post treatment (SVR24) ] [ Designated as safety issue: No ]
  • Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb <10 g/dL, and/or neutropenia as defined by ANC <750 mm3 and/or thrombocytopenia as defined by platelets <50,000 mm3) during the treatment period [ Time Frame: Weeks 1, 2, 4, 6, 8, 12, 20, and 24 (and Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits) ] 
  • Proportion of subjects with the following on treatment IFN-associated symptoms: flu-like symptoms (as defined by pyrexia or chills or pain) and musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) [ Time Frame: Weeks 1, 2, 4, 6, 8, 12, 20, and 24 (and Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits) ] [ Designated as safety issue: Yes ]
    IFN=Interferon
  • Frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), dose reductions, and severity Grade 3/4 laboratory abnormalities [ Time Frame: From Day 1 until the end of treatment 24 weeks or 48 weeks: Weeks 1, 2, 4, 6, 8, 12, 20, and 24 (and Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits) ] [ Designated as safety issue: Yes ]
  • Absolute and percent change from baseline in the CD4 cell count, lymphocyte cell count, and platelet count [ Time Frame: Weeks 4, 8, 12 and 24 (and Week 36 for subjects requiring visit) ] [ Designated as safety issue: Yes ]

Estimated Enrollment 300