Dutch Acute HCV in HIV Study (DAHHS)
Condition: Hepatitis C; Human Immunodeficiency Virus
MeSH terms: Hepatitis C; Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Boceprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Prospective open label proof of concept feasibility interventional clinical trial in which 60
      acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in
      addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at
      week 4.

      The primary hypothesis of this study is that the subset of patients with a Rapid Viral
      Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and
      ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Documented recent HCV genotype 1 infection (≤26 weeks old at the time of the baseline
             visit) according to definition mentioned below.

          2. Plan to start a Standard Of Care therapy for acute HCV consisting of 24 weeks of
             Peginterferon + Ribavirin. HCV RNA plasma viral load at screening >1000 IU/ml.

          3. A previously performed HCV RNA plasma measurement can be used for screening if <4
             weeks old.

          4. On HAART at the time of screening.

          5. Minimum age 18 years.

        Exclusion Criteria:

          1. Disallowed co-medication that cannot be stopped or replaced: Several potentially
             life-threatening drug-drug interactions (DDI) are possible when boceprevir is combined
             with other drugs. Therefore ALL co-medication, including over-the-counter drugs should
             be checked for potential DDI with DDI table in the Dutch summary of product
             characteristics (SPC, appendix A). If the co-medication is not mentioned in the SPC
             DDI table, www.HCV-druginteractions.org should be used.

          2. Contraindications for the use of full dose of peginterferon alpha-2b or ribavirin:
             neutrophils <0,75×109/l or thrombocytes < 100.000×109/l or a Hb <6.2mmol/L, creatinine
             clearance <50ml/min).

          3. History of liver cirrhosis or >F1 fibrosis on fibroscan. Inclusion of patients with a
             chronic well-controlled HBV (HBV-DNA below the limit of detection) with tenofovir,
             lamivudine or emtricitabine therapy is allowed if fibroscan excludes >F1 fibrosis.
             Fibroscan reports <2 years old can be used for screening. Fibroscan is not required
             for other patients at screening.

          4. HAART was started <4 weeks before baseline visit.

          5. Inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse
             transcriptase inhibitors + Raltegravir (Isentress®) 400mg BID or rilpivirine 25mg QD
             or atazanavir (Reyataz®) 300mg QD + ritonavir (Norvir®) 100mg QD.

          6. Patient that virologically failed HAART in the past