Dutch Acute HCV in HIV Study (DAHHS)

Inclusion criteria

• Documented recent HCV genotype 1 infection (≤26 weeks old at the time of the baseline visit) according to definition mentioned below.
• 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.
• A previously performed HCV RNA plasma measurement can be used for screening if <4 weeks old.
• On HAART at the time of screening.
• Minimum age 18 years.

Exclusion criteria

• 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.
• 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).
• 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.
• HAART was started <4 weeks before baseline visit.
• 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.
• Patient that virologically failed HAART in the past