Impact of Direct Acting Antiviral Therapy for Treatment of Hepatitis C Genotypes 1, 3 and 4: A Real Life Experience from India

Varun Mehta; Ramit Mahajan; Vandana Midha; Vikram Narang; Kirandeep Kaur; Arshdeep Singh; Anand Malhotra; Aslam Parvez; Ajit Sood

doi:10.1016/j.jceh.2017.06.003

Impact of Direct Acting Antiviral Therapy for Treatment of Hepatitis C Genotypes 1, 3 and 4: A Real Life Experience from India

J Clin Exp Hepatol. 2018 Mar;8(1):7-14. doi: 10.1016/j.jceh.2017.06.003. Epub 2017 Jun 19.

Authors

Varun Mehta¹, Ramit Mahajan¹, Vandana Midha², Vikram Narang³, Kirandeep Kaur⁴, Arshdeep Singh¹, Anand Malhotra¹, Aslam Parvez¹, Ajit Sood¹

Affiliations

¹ Department of Gastroenterology, Dayanand Medical College, Ludhiana, Punjab, India.
² Department of Internal Medicine, Dayanand Medical College, Ludhiana, Punjab, India.
³ Department of Pathology, Dayanand Medical College, Ludhiana, Punjab, India.
⁴ Department of Pharmacology, Dayanand Medical College, Ludhiana, Punjab, India.

Abstract

Objective: To assess impact of Direct Acting Antiviral (DAA) therapies for treatment of Hepatitis C Virus (HCV) genotypes 1, 3 and 4 in a real-world cohort from India.

Methods: Adults with chronic HCV infection treated with Sofosbuvir (SOF) and Ledipasvir (LDV) (genotypes 1 and 4) or SOF and Daclatasvir (DCV) (genotype 3), with or without Ribavirin (RBV) between December 2015 and December 2016 were included. The primary endpoint was Sustained Virological Response at Post-treatment Week 12 (SVR12).

Results: Of the 648 patients, 181 received SOF/LDV (65 with RBV) and 467 received SOF/DCV (135 with RBV). Most patients were males (65.4%), aged 41-60 years (49.4%) and treatment-naïve (92.6%). Genotype 3 (72.1%) was most common, followed by genotypes 1 (22.4%) and 4 (5.6%). Forty two percent patients (n = 271) had cirrhosis (112 patients were decompensated). SVR12 (modified intention-to-treat) was achieved by 98.1% of patients (512/522) (100% in genotypes 1 and 4, and 97.3% (362/372) in genotype 3). On intention to treat analysis, SVR12 was 88.1% (512/581) [genotype 1-96.8% (121/125), genotype 3-85.2%, genotype 4-93.5% (29/31)]. Seventy patients had treatment failure (non response in 6, virological breakthrough in 2, 10 patients relapsed, 2 died and 50 were lost to follow up). High SVR was observed regardless of HCV genotype, presence of cirrhosis or past history of treatment. No major adverse events warranting discontinuation of treatment were noted.

Conclusions: DAA therapy for HCV genotypes 1, 3 and 4 achieves high SVR rates in all patients, including those with cirrhosis and previous non-responders.

Keywords: DAA, Direct Acting Antiviral; DCV, Daclatasvir; EASL, European Association of Study of the Liver (EASL); ETR, End of Treatment Response; HBV, Hepatitis B; HCC, Hepatocellular Carcinoma; HCV, Hepatitis C Virus; HIV, Human Immunedeficiency Virus; ITT, intention to treat; LDV, ledipasvir; RBV, Ribavirin; RVR, Rapid Virological Response; SOF, Sofosbuvir; SVR, Sustained Virological Response; SVR12, sustained virological response at Post-treatment Week 12; direct acting antivirals; hepatitis C; mITT, modified Intention-to-Treat; real life experience.