Efficacy of 12 week boceprevir in addition to standard of care therapy consisting of peginterferon-alpha-2b and ribavirin for the treatment of acute HCV genotype 1 in HIV co-infected patients. A proof of concept feasibility clinical trial. - Dutch Acute Hepatitis C in HIV Study (DAHHS study)

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•1. Documented recent HCV genotype 1 infection (<=26 weeks old at the time of the baseline visit).
•2. Plan to start a SOC therapy for acute HCV consisting of 24 weeks of P + R.
•3. HCV RNA plasma viral load at screening >1000 IU/ml.
•4. On HAART at the time of baseline visit

•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 comedication 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 alfa-2b or ribavirin: neutrophils <0.50×10*9/l or trombocytes <25×10*9/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 atazanavir (Reyataz®) 300mg QD + ritonavir (Norvir®) 100mg QD.;6. Patient that virologically failed HAART in the past

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