Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)

Summary

Success rates, after retreatment with Peg-Interferon/Ribavirin bitherapy, in patients infected with HCV (hepatitis C virus) genotype 4 and non-responders to a first standard treatment, are disappointing. The association of Asunaprevir and Daclatasvir in combination with the standard-of-care bitherapy has been shown to increase the efficacy of the treatment in non-responders genotype 1-infected patients. Given the absence of current solutions and urgent therapeutic needs for HCV genotype 4-infected patients previously treated with pegylated Interferon/Ribavirin, this pilot study aims to evaluate the efficacy and safety of a quadritherapy associating Asunaprevir, Daclatasvir, pegylated Interferon alpha-2a and Ribavirin, in this very difficult to treat population. 60 subjects will be enrolled. The primary endpoint will be the rate of sustained virological response (SVR), defined by an undetectable HCV RNA, at Week 36 (12 weeks after the end of a 24 weeks quadritherapy).

Timeline

Start

2013-11

Primary completion

2015-02

Completion

2015-04

Publications

• Results Roulot D, Thibault V, Laforest C, Fontaine H, Bronowicki JP, Asselah T, Bourliere M, Canva V, Leroy V, Loustaud-Ratti V, Ouzan D, Zoulim F, Schischmanoff O, Rousseau C, Renault A, Petrov-Sanchez V, Diallo A, Bellissant E, Serfaty L; ANRS HC32 QUATTRO study group. Efficacy of daclatasvir-based quadruple therapy in nonresponder patients infected by hepatitis C virus genotype 4: the ANRS HC32 QUATTRO study. Eur J Gastroenterol Hepatol. 2018 Mar;30(3):302-309. doi: 10.1097/MEG.0000000000001035.

Drugs

Indications