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Liver Int. 2018 Dec;38(12):2137-2148. doi: 10.1111/liv.13863. Epub 2018 May 14.

Generic sofosbuvir-based direct-acting antivirals in hepatitis C virus-infected patients with chronic kidney disease.

Author information

1
Department of Hepatology and Liver Transplatation, Institute of Liver and Biliary Sciences, New Delhi, India.
2
Department of Nephrology, Institute of Liver and Biliary Sciences, New Delhi, India.
3
Department of Virology, Institute of Liver and Biliary Sciences, New Delhi, India.

Abstract

BACKGROUND & AIMS:

There is scant data on use of sofosbuvir containing directly acting antiviral (DAA) regimens in chronic kidney disease (CKD) patients. Recently generic versions of DAAs have become available in low-income countries including India. The aim of this study was to study the efficacy and safety of generic sofosbuvir in combination with generic ribavirin, ledipasvir or daclatasvir in HCV-infected patients with CKD including patients with advanced CKD (CKD stage 4 or 5 with an estimated glomerular filtration rate (GFR) <30 mL/min or those on dialysis).

METHODS:

Seventy-one CKD patients (76% male, 84.5% on maintenance haemodialysis, 23.9% cirrhosis) with HCV infection were included in the study. Full-dose sofosbuvir was used in combination with ribavirin (n = 26, for 24 weeks, 69.2% genotype 1, 30.8% genotype 3), ledipasvir (n = 26, for 12 weeks, all genotype 1) and daclatasvir (n = 19, for 12 weeks, all genotype 3).

RESULTS:

Sustained virological response (SVR) (HCV RNA <12 IU/mL) at 12 weeks after stopping treatment was seen in 100% of the patients in all the 3 groups. At 24-week follow-up after end of therapy, 1 patient in sofosbuvir plus ledipasvir group relapsed. At 48-week follow-up after end of therapy, 1 more patient in sofosbuvir plus ribavirin group relapsed.

CONCLUSION:

Full-dose sofosbuvir-based DAA therapy using generics is highly effective for individuals with HCV infection and CKD including advanced CKD (CKD stage 4 or 5 with an e-GFR <30 mL/min or those on dialysis).

KEYWORDS:

chronic kidney diseases; dialysis; direct-acting antiviral; hepatitis c; sofosbuvir

PMID:
29676846
DOI:
10.1111/liv.13863

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