Title of article :
The Efficacy of 12 Weeks of Sofosbuvir, Daclatasvir, and Ribavirin in
Treating Hepatitis C Patients with Cirrhosis, Genotypes 1 and 3
Author/Authors :
Malekzadeh Reza نويسنده , Alavian Seyed-Moayed نويسنده , Poustchi Hossein نويسنده Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran Poustchi Hossein , Sharifi Amir Houshang نويسنده Iranian Research Center for HIV/AIDS (IRCHA), Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran. Sharifi Amir Houshang , Haj-Sheykholeslami Arghavan نويسنده Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, IR Iran , Merat Shahin نويسنده , Fattahi Babak نويسنده Liver and Pancreatobiliary Diseases Research Center,
Digestive Diseases Research Institute, Tehran University of Medical
Sciences, Tehran, Iran , Nateghi-Baygi Alireza نويسنده Liver and Pancreatobiliary Diseases Research Center,
Digestive Diseases Research Institute, Tehran University of Medical
Sciences, Tehran, Iran
Abstract :
Background The combination of sofosbuvir and daclatasvir can be
used to treat all genotypes of hepatitis C. Current guidelines for
treating hepatitis C cirrhosis do not clarify weather 12 weeks or 24
weeks of treatment is appropriate. Objectives In the present study, we
aimed at evaluating the efficacy of sofosbuvir, daclatasvir, and
ribavirin given for 12 weeks in treating cirrhotic patients with
hepatitis C genotypes 1 and 3 infections. Methods One hundred patients
with hepatitis C and cirrhosis infected with Genotypes 1 and 3 were
included in the present study. They were treated with 1 tablet of a
combination pill of 400 mg sofosbuvir and 60 mg daclatasvir daily and
weight-based ribavirin for 12 weeks. Response to treatment was assessed
12 weeks after the end of the treatment with a sensitive assay (SVR12).
This study was registered with ClinicalTrials.gov, ID: NCT02596880.
Results One patient developed increased creatinine level following
severe diarrhea and gastroenteritis and was excluded, 1 patient died due
to unrelated reasons and 4 others were lost to follow-up. Among the 94
patients who finished the study, 92 achieved SVR12 (98%, per-protocol,
92% intention-to-treat). None of the patients reported any side effects.
Of the 100 original patients, 56 were Genotype 1 and 44 were Genotype 3.
One of the two patients not achieving SVR12 was Genotype 1, and the
other two were Genotype 3. Conclusions The fixed-dose combination drug
of sofosbuvir and daclatasvir given together with weight-base ribavirin
for 12 weeks is extremely effective and safe in treating HCV patients
with Genotypes 1 and 3 and cirrhosis.
