Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in "real-life" cohort.
BACKGROUND
The safety and efficacy of sofosbuvir-based treatment (sofosbuvir and ribavirin with or without pegylated interferon-α) for hepatitis C virus (HCV) infection has been established in clinical trials. However, there is limited data regarding safety and efficacy of sofosbuvir-based treatment for HCV infection in a "real-life" cohort. We describe our experience with sofosbuvir-based treatment for HCV infection in a real-life cohort.


METHODS
This was a prospective, nonrandomized and observational study at a tertiary care centre in Surat, India. The primary end-point was proportion of the study patients who achieved a sustained virological response 12 weeks after cessation of treatment (SVR 12). Secondary end-points of the study include SVR 4, virological relapse and appearance of adverse events.


RESULTS
A total of 107 patients with chronic HCV who received sofosbuvir-based treatment were included in the study. During study period, two patients died due to severity of liver complications. Hence, overall rate of SVR 4 and SVR 12 was 98.1 % (n = 103/105) and 94.3 % (n = 99/105), respectively. Among 67 patients with HCV genotype-3 infection, the SVR 12 rate was 92.5 % (n = 62/67), and among 38 patients with HCV genotype-1 infection, the rate of SVR 12 was 97.4 % (n=37/38). A total of 32 (29.9 %) patients reported adverse events during the course of sofosbuvir-based treatment. None of the patient discontinued treatment due to adverse event.


CONCLUSIONS
Sofosbuvir-based treatment is safe and efficacious in clinical practice in Indian patients with HCV genotype-1 and genotype-3 infection.
Department of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India. rmgastro@yahoo.com.
Rajiv
R
Mehta
Department of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India.
Mayank
M
Kabrawala
Department of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India.
Subhash
S
Nandwani
Department of Physiology, Government Medical College, Majuragate, Surat, 395 001, India.
Rini
R
Tekriwal
Department of Physiology, Government Medical College, Majuragate, Surat, 395 001, India.
Payal
P
Nandaniya
Department of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India.
Mrunal
M
Shah
Department of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India.
Vishwa
V
Bhayani
D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000008:administration & dosage; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000998:Antiviral Agents; D016898:Interferon-alpha; D012254:Ribavirin; D000069474:Sofosbuvir
Direct acting antivirals; Hepatitis C; Pegylated interferon; Ribavirin; Sofosbuvir