Hemodialysis Patients Treated for Hepatitis C Using a Sofosbuvir-based Regimen

Abstract

IntroductionThere is paucity of data on sofosubvir (SOF)−based therapy in patients on maintenance hemodialysis (MHD). The objective of this report is to describe our experience using SOF-based direct antiviral agent (DAA) therapy in MHD patients in India.MethodsAll patients on MHD and treated with SOF-based therapy were included in this study. Before starting treatment, viral load, genotype, liver fibroscan, and upper gastrointestinal endoscopy were performed in all patients. SOF 400 mg/d or on an alternate day, ribavirin 200 mg/d and daclatasvir 60 mg/d were used in different regimens. Hepatitis C virus RNA was assessed at day 10 and at 4 weeks, at end of therapy, and at 12 weeks after stopping therapy.ResultsA total of 62 treatment-naïve patients were included. Mean age was 33.3 ± 10.2 years; 66% were men. Median number of copies were 106/dl. None had clinical evidence of cirrhosis. The most common genotype was genotype 1 in 64.5% of cases, followed by genotype 3 in 29% of cases. Thirty-nine patients were treated with SOF every other day/ribavirin, 2 patients with SOF daily/ribavirin, 6 with SOF every other day/daclatasvir, and 15 patients with SOF daily/daclatasvir. All patients were treated for 12 weeks. Fifty-nine (95.2%) patients had a sustained viral response (SVR). There was no impact of genotype on SVR. Twenty-three patients (37%) had complications while on therapy; 13 (20.3%) had dyspepsia, 4 had tuberculosis, and 3 had bacterial pneumonia. Most of the patients (n = 23; 56%) in the ribavirin group required an increase in the erythropoietin dose. No patient discontinued therapy due to complications.DiscussionSOF-based DAAs were well tolerated and efficacious in this cohort of patients on MHD.

Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

“…SVR rate in his study was 95.2%. Most of the patients in the RBV group (n = 23; 56%) required an increase in the erythropoietin dose; however, no patients discontinued therapy because of complications . The lower SVR rate in our haemodialysis cohort may be related to the small number of patients and the difference in RBV and SOF dosage.…”

“…Though smaller doses of the drug (200 mg/d or 400 mg on alternate day) were used by some investigators, several authors showed lower SVR rates with such doses . On the other hand, high efficacy and safety of full dose SOF‐containing regimens in patients with severe renal impairment were also demonstrated by many investigators …”

Pharmacokinetics and drug interactions of medications used to treat hepatitis C virus infection in the setting of chronic kidney disease and kidney transplantation

“…Twenty‐three patients (37%) had complications while on therapy; 13 (20.3%) had dyspepsia, 4 (6%) had tuberculosis, and 3 (5%) had bacterial pneumonia. Twenty‐three patients (56%) in the RBV group had worsening anemia, requiring an increase in the erythropoietin . Further studies are required to better establish the role of sofosbuvir‐based regimen in CKD stages 4 to 5 and ESRD.…”

Effectiveness of Sofosbuvir Regime in Hepatitis C Virus Infection in Hemodialysis Pakistani Patients: Single Centre Study

“…However, the issue related to DAAs that various DAA drugs are not universally available in all countries 12 . Like in Pakistan, only SOF and subsequently Daclatasvir were available in 2015 to 2017.…”

“…Like in Pakistan, only SOF and subsequently Daclatasvir were available in 2015 to 2017. Because of suboptimal SVR, higher cost, and the moderate degree of adverse effects of IFN-based therapy, there was an intense interest in using DAAs in patients with endstage renal disease 12 .…”