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Use of sofosbuvir based regimen in patients with end-stage renal disease and chronic hepatitis C; an open label, non-randomized, single arm, single center study from Pakistan

Rajesh Mandhwani, Farina M.Hanif, Ghulamullah Lail, Nasir Hassan Luck, Muhammad Ali Khalid, Muhammad Manzoor ul Haque, Syed Mudassir Laeeq, Tahir Aziz
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Abstract

Aim: we aimed to determine the virological response and safety of Sofosbuvir-based direct-acting antiviral agents (DAAs) in chronic hepatitis C (CHC) patients on long-term hemodialysis (HD).

Background: With the advent of interferon-free DAAs, the treatment of CHC has been revolutionized. Pakistan is among the countries where novel sofosbuvir (SOF)-free antiviral agents are not available.

Methods: This non-randomized, single-arm, open-label study enrolled all HD patients with chronic HCV infection after informed consent. They were treated with SOF in combination with Ribavirin (RBV) with either interferon (IFN group) or daclatasvir (DAC group), with the virological response assessed according to standard guidelines. Data were analyzed using SPSS version 20.00.

Results: Out of 133 patients, the majority (72.9%) were males with the mean age of 31.92 ± 9.88 years. Most patients (50.3%) had HCV genotype (GN) 1, followed by GN 3 in 42.9%, 4 in 1.48% and 2 in 0.7%, while mix GN was documented in 6 (4.4%) patients. Among these, 60 (45.1 %) patients received standard SOF, IFN, and RBV (IFN group) and 73 (54.9 %) received SOF, DAC and RBV (DAC group). End of treatment and sustained virological response at 12 weeks post-treatment were achieved in 133 (100%) and 129 (97 %) patients, respectively. The adverse effects were anemia in 58 (43.6 %) patients and elevated alanine transaminases in 11 (8.1%) patients.

Conclusion: SOF in combination with either IFN or DAC is an equally efficacious and effective treatment regimen for patients on maintenance HD, especially in resource-poor countries.

Keywords: End-stage renal disease, hemodialysis, Hepatitis C virus, Interferon, Sofosbuvir, Sustained virological response.

(Please cite as: Mandhwani R, Hanif FM, Lail GH,  Luck NH, Khalid MA, Muh ul Haque MM, et al. Use of Sofosbuvir based regimen in patients with end-stage renal disease and chronic hepatitis C; an open label, non-randomized, single arm, single center study from Pakistan. Gastroenterol Hepatol Bed Bench 2020;13(2):141-146).


Keywords

End stage renal disease, hepatitis C virus, interferon, anti-viral treatment response, sustained virological response

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DOI: https://doi.org/10.22037/ghfbb.v13i2.1856