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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)
Sponsor: ANRS, Emerging Infectious Diseases
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).
Official title: Pilot Study to Assess Efficacy and Safety of a Quadruple Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Non-responders to Pegylated Interferon-Ribavirin Regimen
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2013-11
Completion Date
2015-04
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Asunaprevir
Asunaprevir 100 mg, 1 capsule twice a day from Day 0 to Week 24
Daclatasvir
Daclatasvir 60 mg, 1 tablet once a day from Day 0 to Week 24
Ribavirin
Ribavirin tablets or capsules 200 mg, weight-based daily dose ( \<75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), from Day 0 to Week 24
Pegylated Interferon alpha-2a
Pegylated Interferon alpha-2a, by subcutaneous injection 180µg / week, from Day 0 to Week 24
Locations (25)
Hôpital AVICENNE
Bobigny, France
Hôpital Jean Verdier
Bondy, France
Hôpital de Haut Lévêque
Bordeaux Pessac, France
Hôpital Beaujon
Clichy, France
Centre Hospitalier Intercommunal
Créteil, France
Hôpital Henri Mondor
Créteil, France
Hôpital Albert Michallon
Grenoble, France
Hôpital Claude Huriez
Lille, France
Hôpital Dupuytren
Limoges, France
Hôpital de la Croix Rousse
Lyon, France
Fondation Hôpital Saint Joseph
Marseille, France
Hôpital Saint Eloi
Montpellier, France
Hôpital de Brabois
Nancy, France
Hôpital de l'Hôtel Dieu
Nantes, France
Hôpital de l'Archet
Nice, France
Hôpital de La Source
Orléans, France
Hôpital Saint Antoine
Paris, France
Hôpital Pitié Salpêtrière
Paris, France
Hôpital Cochin
Paris, France
Hôpital Tenon
Paris, France
Hôpital Pontchaillou
Rennes, France
Hôpital Charles Nicolle
Rouen, France
Institut Arnault Tzank
Saint-Laurent-du-Var, France
Hôpital Purpan
Toulouse, France
Hôpital Paul Brousse
Villejuif, France