Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV
Condition: Acute Hepatitis C; Human Immunodeficiency Virus; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis; Immunologic Deficiency Syndromes
Intervention: Grazoprevir/Elbasvir 100mg/50mg
Intervention description: Grazoprevir/Elbasvir 100mg/50mg
Intervention MeSH terms: Grazoprevir; Elbasvir-grazoprevir drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Hepatitis C; Human Immunodeficiency virus; Grazoprevir; Elbasvir

Summary:

      New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure
      95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir
      (MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA
      approved combination DAA therapy.

      It is likely that the synergistic effect of the host's immune response and antiviral therapy
      when given during the first 6 months of HCV infection makes antiviral therapy during acute
      HCV infection more effective. In this study the investigators would like to document that
      treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can
      ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss
      in efficacy.

      Study design and intervention:

      Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4
      patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily
      combination tablet).

      Study population:

      80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV
      treatment centers in the Netherlands and Belgium will be included.

      Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT
      study population (=genotype 1 and 4).
    

Eligibility criteria:

        Inclusion Criteria:

          1. HIV positive

          2. Acute HCV genotype 1 or 4 infection (≤26 weeks old at the baseline visit)

        Exclusion Criteria:

          1. Not on cART and a CD4 <500 at the time of screening

          2. Patients on cART for >6 months with a HIV viral load >400 copies

          3. Disallowed co-medication that cannot be stopped or replaced

          4. History of liver cirrhosis of any etiology. Inclusion of patients with a chronic
             well-controlled HBV (HBV-DNA <below the limit of detection) is allowed if fibroscan
             excludes >F1 fibrosis

          5. Protease inhibitor based and NNRTI based cART regimens are not allowed. Therefore, the
             inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse
             transcriptase inhibitors and an allowed third agent which can be raltegravir
             (Isentress®) 400mg BID, dolutegravir (Tivicay) 50mg QD or rilpivirine 25mg QD.