Observational Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 21, 2016; 22(43): 9613-9622
Published online Nov 21, 2016. doi: 10.3748/wjg.v22.i43.9613
Hepatitis C virus therapy with peg-interferon and ribavirin in Myanmar: A resource-constrained country
Naomi Khaing Than Hlaing, Debolina Banerjee, Robert Mitrani, Soe Htet Arker, Kyaw San Win, Nyan Lin Tun, Zaw Thant, Khin Maung Win, K Rajender Reddy
Naomi Khaing Than Hlaing, Soe Htet Arker, Kyaw San Win, Nyan Lin Tun, Zaw Thant, Khin Maung Win, Department of Hepatology, Mandalay General Hospital, Mandalay 02121, Myanmar
Debolina Banerjee, Robert Mitrani, K Rajender Reddy, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA 19104, United States
Author contributions: Hlaing NKT and Banerjee D contributed equally to this work; Hlaing NKT and Reddy KR designed the research; Hlaing NKT, Arker SH, Win KS, Tun NL, Thant Z and Win KM performed the research; Banerjee D analyzed the data; Banerjee D and Mitrani R wrote the paper.
Institutional review board statement: This study did not have a formal Institutional Review Board statement; however, this study was conducted in accordance with the prevailing scientific standards of Myanmar.
Informed consent statement: All study participants, or their legal guardian, provided informed verbal consent prior to study enrollment.
Conflict-of-interest statement: Reddy KR serves on the advisory boards for BMS, Gilead, Abbvie, Merck and Jansen. Research support from BMS, Gilead, Abbie, Merck and Janssen is paid to the University of Pennsylvania. All other authors do not have any conflicts-of-interest.
Data sharing statement: Technical appendix, statistical code and dataset available from the corresponding author at rajender.reddy@uphs.upenn.edu. Participants gave informed verbal consent for data sharing, and the presented data are anonymized.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: K Rajender Reddy, MD, Ruimy Family President’s Distinguished Professor of Medicine, Professor of Medicine in Surgery, Director of Hepatology, Director of the Viral Hepatitis Center, and Medical Director of Liver Transplantation, Division of Gastroenterology and Hepatology, University of Pennsylvania, 2 Dulles, 3400 Spruce Street, Philadelphia, PA 19104, United States. rajender.reddy@uphs.upenn.edu
Telephone: +1-215-6624276 Fax: +1-215-6151601
Received: August 16, 2016
Peer-review started: August 17, 2016
First decision: September 5, 2016
Revised: September 13, 2016
Accepted: September 28, 2016
Article in press: September 28, 2016
Published online: November 21, 2016
Abstract
AIM

To investigate peg-interferon (peg-IFN) and ribavirin (RBV) therapy in Myanmar and to predict sustained virologic response (SVR).

METHODS

This single-center, open-label, study was conducted in Myanmar between 2009 and 2014. A total of 288 patients infected with HCV genotypes 1, 2, 3 and 6 were treated with peg-IFN alpha-2a (180 μg/wk) or alpha-2b (50 to 100 μg as a weight-based dose) and RBV as a weight-based dose (15 mg/kg/d). Treatment duration was 48 wk for genotypes 1 and 6, 24 wk for genotype 2, and 24 or 48 wk for genotype 3 based on rapid virologic response (RVR). Those co-infected with hepatitis B received 48 wk of therapy.

RESULTS

Overall, SVR was achieved for 82% of patients and the therapy was well tolerated. All patients achieved SVR at equivalent rates regardless of HCV genotype (P = 0.314). Low fibrosis scores (P < 0.001), high baseline albumin levels (P = 0.028) and low baseline viral loads (P = 0.029) all independently predicted SVR. On the other hand, IL-28B TT and CC genotypes were not found to significantly predict SVR (P = 0.634; P = 0.618). Among those who completed treatment, the occurrence of RVR showed a > 96% positive predictive value for achieving SVR. Treatment duration did not significantly impact the likelihood of achieving SVR for patients infected with genotype 3 HCV (P = 0.371). The most common adverse events were fatigue (71%) and poor appetite (60%). Among patients with genotype 3 HCV, more patients in the 48-wk treatment group required erythropoietin than in the 24-wk treatment group (61.1% vs 49.2%).

CONCLUSION

SVR rates were high with peg-IFN and RBV therapy in Myanmar. Fibrosis scores, baseline albumin, HCV RNA levels and RVR independently predicted SVR.

Keywords: Hepatitis C virus, Pegylated-interferon, Ribavirin, Sustained virologic response, Rapid virologic response

Core tip: Peg-interferon (peg-IFN) and ribavirin (RBV) therapy was a viable treatment option for hepatitis C virus (HCV)-infected patients in Myanmar due to its availability and affordability. Currently, direct-acting antiviral agents are not widely accessible to the Myanmar population. Therefore, HCV treatment is still being conducted with peg-IFN and RBV therapy. This treatment regimen was shown to be reasonably efficacious with minimal adverse events. Fibrosis scores, baseline albumin, HCV RNA levels and rapid virologic response all independently predicted sustained virologic response.