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Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function.

ABSTRACT: BACKGROUND & AIMS:Renal clearance is the major elimination pathway for sofosbuvir (SOF). We assessed the safety and efficacy of SOF-containing regimens in patients with varying baseline estimated glomerular filtration rate (eGFR). METHODS:HCV-TARGET database is a multicentre, longitudinal 'real-world' treatment cohort. RESULTS:A total of 1789 patients [genotypes 1 (72%), 2 (17%) 3 (9%), 4-6 (2%)] had baseline eGFR determination: 73 with eGFR?45 (18 with eGFR?30, 5 on dialysis) were compared to 1716 with eGFR>45 ml/min/1.73 m(2) . Patients with baseline eGFR?45 vs. >45 differed in being female (55% vs. 36%), age ?65 years (24% vs. 16%), Black race (22% vs. 12%), having cirrhosis with decompensation (73% vs. 24%) and being post-transplant (49% vs. 10%), all P < 0.05. All patients with eGFR?45 were treated with SOF 400 mg/day (including those on haemodialysis) and had median starting ribavirin (RBV) dose of 800 mg (IQR: 400-1200). Sustained virologic response (SVR) frequencies were similar across eGFR groups, ranging from 82-83%. Patients with eGFR ?45 more frequently experienced anaemia, worsening renal function and serious AEs (all P < 0.05), and these associations persisted when limiting analysis to RBV-free regimens. Patients with baseline eGFR?30 and eGFR 31-45 had similar frequencies of efficacy and safety outcomes. CONCLUSIONS:Sustained viral clearance was achieved in 83% of patients with renal impairment (eGFR ?45 ml/min/1.73 m(2) ) treated with SOF-containing regimens. However, these patients had higher rates of anaemia, worsening renal dysfunction and serious adverse events regardless of use of RBV. Patient with renal impairment require close monitoring and should be treated by providers extensively experienced with SOF-containing regimens.

SUBMITTER: Saxena V

PROVIDER: S-EPMC6453817 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function.

Saxena Varun V Koraishy Farrukh M FM Sise Meghan E ME Lim Joseph K JK Schmidt Monica M Chung Raymond T RT Liapakis Annmarie A Nelson David R DR Fried Michael W MW Terrault Norah A NA

Liver international : official journal of the International Association for the Study of the Liver 20160324 6

<h4>Background & aims</h4>Renal clearance is the major elimination pathway for sofosbuvir (SOF). We assessed the safety and efficacy of SOF-containing regimens in patients with varying baseline estimated glomerular filtration rate (eGFR).<h4>Methods</h4>HCV-TARGET database is a multicentre, longitudinal 'real-world' treatment cohort.<h4>Results</h4>A total of 1789 patients [genotypes 1 (72%), 2 (17%) 3 (9%), 4-6 (2%)] had baseline eGFR determination: 73 with eGFR≤45 (18 with eGFR≤30, 5 on dialys ...[more]

PMID: 26923436

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Project description:BackgroundWith the appearance of oral direct-acting antivirals (DAAs), the field of hepatitis C virus (HCV) treatment has been dramatically changed. This evolution makes possible for all oral treatments to be available for the treatment of HCV-infected patients. The aims of this review were to report the efficacy and safety of sofosbuvir (SOF)-based regimens for the treatment of patients with chronic HCV infection and to provide our clinical perspectives on these regimens.MethodsA literature search of clinical studies published in PubMed and posted on ClinicalTrials.gov website was performed to identify studies evaluating the efficacy or safety of SOF-containing treatment regimens.ResultsA total of 23 clinical trials were examined in the review. The evaluated SOF-based regimens are as follows: SOF/daclatasvir (DCV) ± ribavirin (RBV), SOF/ledipasvir (LDV) ± RBV, SOF/simeprevir (SMV), SOF/velpatasvir (VEL) ± RBV, and SOF/RBV ± peginterferon (peg-IFN). These SOF-based regimens were at least effective and safe for HCV-infected patients with or without cirrhosis. The SOF/VEL ± RBV regimen, a pan-genotypic DAA regimen, was effective for the treatment of patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection. The 24-week SOF/RBV regimen was as effective as the 12-week SOF/RBV/peg-IFN regimen. Patients with HCV genotype 3 infection could have benefits from the use of the 24-week SOF/RBV regimen. For cirrhotic patients with HCV genotype 3 infection, the 12-week SOF/RBV/peg-IFN regimen could be considered as an alternative treatment option when access to SOF-based regimens with other DAAs is limited. In the included studies, significant adverse events due to SOF-based regimens were not reported.ConclusionThe clinical trials suggest that SOF-based treatment regimens for HCV-infected patients with or without cirrhosis can be at least effective and safe patient-convenient medications. However, it is necessary to monitor HCV-infected patients, since rare adverse events, drug-drug interactions, and drug-disease interactions can occur in real clinical settings.

Dataset Information

Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function.

Publications

Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function.

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