The Efficacy of 12 Weeks of Sofosbuvir, Daclatasvir, and Ribavirin in Treating Hepatitis C Patients with Cirrhosis, Genotypes 1 and 3

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.

Systematic review with meta‐analysis: effectiveness and tolerability of interferon‐free direct‐acting antiviral regimens for chronic hepatitis C genotype 1 in routine clinical practice in Asia

“…Of the 8262 citations and 23 additional manually searched articles evaluated, we included 41 studies published in full articles (Figure ) . Of those, four studies were used only to extract data for subgroup analysis because the overall SVR data were already reported and extracted for overlapping populations in other four included studies .…”

Estimating the incidence rate of hepatitis B and C in East Azerbaijan, Islamic Republic of Iran

“…Moreover, Merat et al reported an increase in HCV seroprevalence in the country (19). All Iranian HCV patients were treated using SOVODAK -a single pill containing Sofosbuvir and Daclatasvirwhich has been shown to provide a 98% sustained virologic response (SVR) in HCV patients (20). Therefore, it is expected in this case that the WHO target for 2020 will be reached.…”

Update on Recommendations for the Clinical Management of Hepatitis C in Iran 2017

“…In HCV-1 infected patients with a previous history of PegIFN + RBV therapy and/or cirrhosis (child A), intensification of 12 weeks of SOF/LDV or SOF + DCV with adding RBV is recommended, however, the latter groups can be treated with 12 weeks of SOF/VEL without addition of RBV (2,11,12). Moreover, decompensated cirrhosis (child B and C) patients with HCV-1 infection can be treated for 24 weeks of SOF/LDV, SOF + DCV or SOF/VEL with addition of RBV (4,6,11,13). However, in RBV-intolerant cases, treatment can be extended to 24 weeks of SOF/LDV, SOF + DCV, or SOF/VEL without RBV.…”

“…Since 2015, various all-oral regimens approved for treatment of HCV with introduction of new treatment regimens in 2017 including sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) and glecaprevir/pibrentasvir (GLE/PIB). Hopefully, the generic DAAs including SOF, sofosbuvir/ledipasvir fixed dose combination (SOF/LDV), daclatasvir (DCV) and sofosbuvir/daclatasvir fixed dose combination (SOF/DCV) are available in Iran since 2016 (5,6). With availability of these generic DAAs, Iranian healthcare system decided to eliminate hepatitis C in the country with an estimation of 186000 infected patients (7,8).…”