Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

Phase 3 Completed 310 enrolled Boehringer Ingelheim

RandomizedParallel-groupOpen-labelTreatment

Summary

the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

Timeline

Start: 2011-09
Primary completion: 2013-09
Completion: 2014-06

Outcome

Met primary endpoint

registry NUMBER Faldaprevir - Total: 71.8 (66.7 to 76.8) percentage of participants NCT01399619 ↗

registry p <0.0001; normal approximation; note: p-value corresponds to a two sided test against the historical rate of 40%. NCT01399619 ↗

Publications

Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Faldaprevir	Small molecule	120 mg	—
Subject	Faldaprevir	Small molecule	240 mg	—
Subject	Ribavirin	Small molecule	—	—
Subject	pegylated interferon-α2a	Unknown	—	—