Efficacy of Combination of Daclatasvir and Sofosbuvir for Management of HCV Genotype 3 Patients

Abstract

Introduction: Chronic infection with hepatitis C virus (HCV) affects approximately 170 million people worldwide and is a major cause of cirrhosis and hepatocellular carcinoma. Globally, 2.2% of the world's population is suffering from HCV. HCV is classified into six major genotypes. Genotypes 1, 2, and 3 are found worldwide. Daclatasvir is a first-in-class HCV NS5A replication complex inhibitor, and sofosbuvir is a nucleotide analogue HCV NS5B polymerase inhibitor. Both have potent antiviral activity and broad genotypic coverage and are administered orally once daily. Each is effective in patients infected with genotype 1, 2, or 3.

Objective: The objective of this study was to determine the frequency of sustained virological response (SVR12) of Daclatasvir plus Sofosbuvir combination for management of HCV genotype 3 infections in non-cirrhotic, treatment-naive patients.

Study Design: Descriptive case series.

Setting: Gastroenterology Department of Shifa International Hospital Islamabad.

Study Duration: Present research was conducted from 24-05-2019 to 24-11-2019.

Material and Methods: After approval from the ethical committee the study was started. All consecutive patients fulfilling selection criteria were enrolled in the study through OPD of Department of Gastroenterology, Shifa International Hospital, Islamabad. Informed consent was obtained. Demographic information (name, age, gender) was recorded. All basic labs were checked including CBC, LFTs, Creatinine and INR. Then patients were prescribed Daclatasvir 60mg and Sofosbuvir 400mg orally once daily. Patients were followed-up in OPD for 12 weeks. Then the patients were advised to follow-up after 12 weeks at the end of treatment at which time HCV PCR12 were checked. Reports were assessed and if HCV RNA<15IU/mL, then it was labeled as Sustained Virological Response - 12 is achieved (as per operational definition). The primary end point was sustained virological response after 12 weeks of end of treatment assessed by a sensitive molecular method. All this information was recorded through structured proforma (attached). All the lab investigations were done in the hospital laboratory and verified by pathologists.

Results: From 75 patients, it was observed that the minimum age was 25 years and maximum age was 70 years with mean and standard deviation of the age was 48.65 ± 13.72 years. Male patients were 56% while female patients were 44%. Diabetes mellitus was present in 62.7% patients while it was absent in 37.3% patients. SVR12 was achieved in 85.3% patients while it was not achieved in 14.7% patients.

By using chi-square test it was found that there was no significant association between SVR12 and gender having p-value = 0.916. There was no significant association between SVR12 and Diabetes mellitus having p-value = 0.455. Significant association was not found between age and SVR12 with p-value 0.076.

Conclusion: Sustained virological response (SVR12) is achieved in 85.3% HCV genotype 3 infection patients used Daclatasvir plus Sofosbuvir combination. Effect modifiers have no significant influence.