Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end‐stage renal disease on maintenance haemodialysis

Abstract

Background & Aims There is emerging data on the use of Sofosbuvir‐based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with end‐stage renal disease (ESRD) on maintenance haemodialysis (MHD). We evaluated the safety and efficacy of Sofosbuvir plus Velpatasvir fixed‐dose combination in CHC patients with ESRD on MHD. Methods Fifty‐one CHC patients with ESRD on MHD were included in a real‐life prospective study. All patients irrespective of genotype; presence of cirrhosis; treatment naive or experienced status were treated with full‐dose Sofosbuvir (400 mg) plus Velpatasvir (100 mg) fixed‐dosed combination given daily for 12 weeks. The efficacy was assessed by the sustained virological response (SVR12) with negative HCV RNA 12 weeks after the end of treatment (ETR). Side effects if any were recorded in all patients. Results The median HCV RNA level in 51 CHC patients [Males 41 (80.4%), mean age 42.8 ± 14.6 years] was 2.0 × 106 IU/mL. HCV genotype was available in 19 patients with predominant genotype 1 in 15 (79%) patients. Ten (19.6%) patients had evidence of cirrhosis (defined as LSM ≥ 12.5 kPa on Transient Elastography), and 8 (15.6%) patients were treatment experienced. Testing for ETR was done in 36 patients and all 36 (100%) patients achieved ETR, and 49 patients (96%) achieved SVR 12. All 51 patients tolerated the Sofosbuvir + Velpatasvir combination, with none of the patients reporting any serious adverse event. Conclusion Sofosbuvir plus Velpatasvir fixed‐dose combination is safe and effective in treating CHC in patients with ESRD on MHD.

Sofosbuvir in HCV patients with chronic kidney disease: No time for caution

“…The primary end‐point of SVR was achieved in 49 (96%) patients after 12 weeks of full‐dose SOF plus velpatasvir combination and no safety concerns were recorded. Interestingly, none of patients experienced worsening of kidney disease over the entire length of the study 14 . Lastly, a multicentre study recruiting 191 patients with severe renal impairment, including those with eGFR <30 mL/min not on haemodialysis, and those with compensated and decompensated liver disease, reported SVR12 rates in line with previous studies: 95.0% and 90.0% in patients with compensated and decompensated liver disease respectively.…”

“…More recently, SOF has been confirmed safe by another real‐life prospective cohort from India, including 51 patients with end‐stage renal disease on maintenance haemodialysis who were treatment naive or experienced 14 . The primary end‐point of SVR was achieved in 49 (96%) patients after 12 weeks of full‐dose SOF plus velpatasvir combination and no safety concerns were recorded.…”

“…Studies on sofosbuvir-containing regimens in patients with severe chronic kidney disease AE, adverse events; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; EP, evaluable population; ESRD, end-stage renal disease; HD, haemodialysis; PP, per-protocol population; pts, patients; QD, once daily; RBV, ribavirin; SOF, sofosbuvir; SVR12, sustained viral response 12 weeks post-treatment; TIW, three times a week; wks, weeks.naive or experienced 14. The primary end-point of SVR was achieved in 49 (96%) patients after 12 weeks of full-dose SOF plus velpatasvir combination and no safety concerns were recorded.…”

Management and Treatment of Hepatitis C: Are There Still Unsolved Problems and Unique Populations?

“…Available data consistently showed optimal rates of SVR with all the approved pangenotypic treatments in patients with severe CKD and on hemodialysis, including full-dose SOF-based regimens [33][34][35]. The magnitude of recent studies confirming the safety profile of SOF is of fundamental importance in contexts where resources are limited and in cases of decompensated cirrhosis where SOF-based regimens with or without RBV represent the only option [33][34][35]37]. As a result, patients with HCV infection and concomitant CKD do not appear as a difficult-to-treat population to date and IFN-free pan-genotypic treatments can be recommended in all patients with kidney disease, without dose-adjustments [25,38].…”

Reply to: “Real-world experience of serial serum levels of GS-331007 in chronic hepatitis C hemodialysis patients during and after sofosbuvir/velpatasvir therapy”

“…More recently, Taneji et al also demonstrated the safety and efficacy of sofosbuvir/velpatasvir in 51 patients with ESRD on maintenance hemodialysis. 3 These findings provide reassurance that the increases in GS-331007 exposure are not clinically relevant and indeed renal impairment, including dialysis, is no longer a contraindication for use of sofosbuvir/velpatasvir as reflected in the product monograph.…”