Sofosbuvir–velpatasvir single-tablet regimen administered for 12 weeks in a phase 3 study with minimal monitoring in India

Abstract

Background and aimsIn clinical studies, sofosbuvir–velpatasvir has demonstrated high cure rates and favorable tolerability in patients chronically infected with chronic hepatitis C virus (HCV) of any genotype. We evaluated the effectiveness and safety of sofosbuvir–velpatasvir administered with minimal medical monitoring to patients in India. MethodsAt 16 sites in India, 129 adult patients with chronic HCV infection of any genotype initiated 12 weeks of once-daily sofosbuvir–velpatasvir (400–100 mg). Patients with compensated cirrhosis or prior treatment experience could be included in the study. Study drug was dispensed monthly, but there were no on-treatment study assessments. The primary efficacy endpoint was rate of sustained virologic response (HCV RNA < 15 IU/mL) 12 weeks after treatment (SVR12), which was compared to a pre-specified performance goal of 85%.ResultsThe majority of patients had HCV genotype 3 infection (70%), followed by HCV genotype 1 (22%). The SVR12 rate was 93% (120/129; 95% CI, 87% to 97%) (p = 0.009 compared with the 85% performance goal). Of the nine patients who did not achieve SVR12, 1 experienced virologic failure, 2 relapsed after treatment, 1 withdrew consent after treatment, and 5 were lost to follow-up (1 during and 4 after treatment). Sofosbuvir–velpatasvir was well-tolerated, and no patients discontinued treatment because of an adverse event. The most frequently reported adverse events were headache (3% of patients), upper abdominal pain (2%), and pyrexia (2%).ConclusionsIn this study conducted at multiple sites in India, sofosbuvir–velpatasvir administered without genotype restriction or on-treatment safety assessments was well-tolerated and highly effective.

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

“…The only difference from our study was that there were no DAAs treatment-experienced patients in the study by Gaur et al, which further reiterates our claim that this combination is highly efficacious even in treatment-experienced patients similar to study by Borgia et alThe results of our study and the two previous studies confirm the high efficacy and safety profile of single tablet, fixed-dose combination of full-dose Sofosbuvir and Velpatasvir in patients with ESRD on MHD. The results of our study have explicated clearly that Sofosbuvir and Velpatasvir fixed-dose combination can be used in ESRD patients with excellent results irrespective of the previous treatment status, genotype, and presence of cirrhosis with minimal monitoring as in non-CKD patients 33.…”

Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan

“…Regarding drug adherence, 98.9% of our patients consumed > 95% of the dispended pills. Because that SOF/VEL has the advantages of easy dosing without food effects, low pill burden, short treatment duration, low risk of treatment-emergent AEs, the excellent drug adherence may contribute to the high SVR 12 rate in our patients [27].…”

Safety and efficacy of Sofosbuvir and Velpatasvir in children with active hepatitis C virus infection undergoing haploidentical transplantation

“…The advent of DAA for HCV has ushered a new era of antiviral therapy in infections, where effective vaccination remains elusive. Amongst the DAA, Sofosbuvir, a nucleotide analogue inhibitor of the NS5B polymerase of HCV, has become the backbone of combination approaches to anti‐HCV therapy, primarily because of high barrier to resistance, pan‐genotypic efficacy, and excellent safety‐profile 8 . This has been combined with protease inhibitors such as simeprevir or NS5A inhibitors such as daclatasvir or ledipasvir with excellent SVR across genotypes.…”