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Daclatasvir and Sofosbuvir with Ribavirin for 24 Weeks in Chronic Hepatitis C Genotype-3-Infected Patients with Cirrhosis: A Phase III Study (ALLY-3C)
- Source :
- Antiviral Therapy. 24:35-44
- Publication Year :
- 2019
- Publisher :
- SAGE Publications, 2019.
-
Abstract
- Background Optimal treatment for patients with HCV genotype-3 infection and liver cirrhosis remains a medical priority. Daclatasvir+sofosbuvir and ribavirin is a recommended option for such patients, but clinical trial data are lacking for treatment >16 weeks. Methods This was a single-arm, Phase III study of daclatasvir+sofosbuvir+ribavirin for 24 weeks in patients with compensated cirrhosis and HCV genotype-3 infection. The primary end point was sustained virological response at post-treatment week 12 (SVR12); the primary objective was to demonstrate statistical superiority to historical SVR12 data for 12 weeks’ daclatasvir+sofosbuvir without ribavirin in genotype-3-infected patients with cirrhosis (95% CI lower bound >79.0%). Results A total of 78 patients were treated (54 treatment-naive, 24 treatment-experienced including 8 with prior sofosbuvir exposure). SVR12 was achieved by 87% (68/78; 95% CI 77.7, 93.7%) of patients in the primary analysis of central laboratory data. One additional patient achieved SVR12 by local testing resulting in an overall SVR12 rate of 88% (95% CI 79.2, 94.6%) and the lower bound of the 95% CI above the historical threshold. SVR12 rates were 93% (50/54) for treatment-naive and 79% (19/24) for treatment-experienced patients. Of the nine non-SVR12 patients, four were lost to follow-up, two relapsed (both sofosbuvir-experienced), two had end-of-treatment virological failure and one discontinued early. There were no unexpected safety signals; only one patient discontinued for an adverse event. Conclusions Daclatasvir+sofosbuvir+ribavirin for 24 weeks was well tolerated and efficacious in HCV genotype-3-infected patients with compensated cirrhosis, with SVR12 outcomes comparable to previously reported outcomes in patients treated with this regimen for 12–16 weeks.
- Subjects :
- Adult
Liver Cirrhosis
Male
medicine.medical_specialty
Pyrrolidines
Cirrhosis
Daclatasvir
Sustained Virologic Response
Sofosbuvir
Antiviral Agents
Gastroenterology
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Pharmacotherapy
Chronic hepatitis
Internal medicine
Ribavirin
Genotype
medicine
Humans
Pharmacology (medical)
Aged
Pharmacology
business.industry
Imidazoles
Valine
Hepatitis C
Hepatitis C, Chronic
Middle Aged
medicine.disease
Infectious Diseases
chemistry
030220 oncology & carcinogenesis
Drug Therapy, Combination
Female
030211 gastroenterology & hepatology
Carbamates
business
medicine.drug
Subjects
Details
- ISSN :
- 20402058 and 13596535
- Volume :
- 24
- Database :
- OpenAIRE
- Journal :
- Antiviral Therapy
- Accession number :
- edsair.doi.dedup.....318774435cd65843366276f38eb1e811