Page 125 - Read Online

Umar et al. Hepatoma Res 2018;4:71 Hepatoma Research
DOI: 10.20517/2394-5079.2018.31

Original Article Open Access

Efficacy and safety of generic daclatasvir +
sofosbuvir ± ribavirin in treatment of genotype 3
infected hepatitis C patients - a real life experience
from Pakistan

1
1
1
2
Muhammad Umar , Tayyab Saeed Akhter , Junaid Sadiq , Samar Saleem , Shoaib Khokhar 1
1 Centre for Liver and Digestive Diseases, Holy Family Hospital, Rawalpindi Medical College and Allied Hospitals, Rawalpindi 46300, Pakistan.
2 Tehsil Headquarter Hospital, Murree 47150, Pakistan.
Correspondence to: Dr. Muhammad Umar, Centre for Liver and Digestive Diseases, Holy Family Hospital, Rawalpindi Medical College
and Allied Hospitals, Rawalpindi 46300, Pakistan. E-mail: drumarpk@yahoo.com

How to cite this article: Umar M, Akhter TS, Sadiq J, Saleem S, Khokhar S. Efficacy and safety of generic daclatasvir + sofosbuvir ±
ribavirin in treatment of genotype 3 infected hepatitis C patients - a real life experience from Pakistan. Hepatoma Res 2018;4:71.
http://dx.doi.org/10.20517/2394-5079.2018.31

Received: 27 Mar 2018 First Decision: 19 Apr 2018 Revised: 6 Jun 2018 Accepted: 18 Oct 2018 Published: 30 Nov 2018
Science Editor: Guang-Wen Cao Copy Editor: Cai-Hong Wang Production Editor: Zhong-Yu Guo

Abstract
Aim: Genotype 3 is the most prevalent genotype in Pakistan. Despite a revolution in the treatment of Hepatitis C,
genotype 3 is still thought to be difficult to treat genotype. The price of patent direct acting antivirals was thought
to a great limiting factor especially for low income countries. In Pakistan low cost generics of daclatasvir and
sofosbuvir are easily available for treatment. The aim of our study is to provide real life local data to determine
their efficacy and safety.

Methods: This open-label, non-randomized, uncontrolled study was carried out at Center for Liver and Digestive
Diseases, Holyfamily Hospital, Rawalpindi. We enrolled patients from March 2016 through March 2018 who were
18 years or older having chronic hepatitis C infection with detectable polymerase chain reaction (PCR), regardless
of whether they were treatment naïve or have experienced Interferon in the past. The patients were offered generic
sofosbuvir 400 mg and daclatasvir 60 mg once daily with or without ribavirin for a period of 12 to 24 weeks. Follow-
up PCRs were performed at 4th week of treatment, end of treatment and 12 weeks post treatment. All those
patients were included in the study that had at least one follow-up PCR during or after the course of treatment.

Results: A total of 102 patients were enrolled in the study with a mean age of 48.11 ± 12.70 including 63% males
and 37% females. All patients were genotype 3. On 4th week follow up, 31/36 (86.11%) patients had quantitative
PCR negative. Out of 102 patients 78 patients had follow up PCR at the completion of therapy with an end of
treatment response of about 96.1%. Thirty patients had a follow up at 12 weeks post treatment with a SVR12 of

© The Author(s) 2018. Open Access This article is licensed under a Creative Commons Attribution 4.0
International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use,
sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long
as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license,
and indicate if changes were made.

www.hrjournal.net