Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis

Abstract

Background/Aims: Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited. Methods:We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR 12 ) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. The safety profiles were reported.Results: The SVR 12 rates in the EP, modified EP and PP were 89.7% (95% confidence interval (CI): 82.5%-94.2%), 94.1% (95% CI: 87.8%-97.3%), and 100% (96 of 96 patients; 95% CI: 96.2%-100%). No patients who failed to achieve SVR 12 were attributed to virologic failures. The SVR 12 rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs).Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR 12 , 84.4% and 64.6% had improved Child-Pugh and Model for End-Stage Liver Disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥ 15 was associated with an improved MELD score of ≥ 3 (odds ratio (OR): 4.13, 95% CI: 1.16-14.71; p = 0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate (eGFR) declines than patients with CKD stage 2 (-0.42 mL/min/1.73m 2 /month; p = 0.01) or stage 3 (-0.56 mL/min/1.73m 2 /month; p < 0.001). 8Conclusions: SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.

Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study

“…Although there were few patients with decompensated LC in our study, high SVR12 rates in both compensated and decompensated LC support the treatment guidelines of KASL and previous studies [ 20 , 32 ]. As glecaprevir/pibrentasvir is contraindicated for decompensated LC and SOF/velpatasvir, an effective DAA for decompensated LC [ 33 ], is still not approved in South Korea, our promising results of LDV/SOF plus ribavirin in decompensated LC provide the possibility of successful HCV treatment in these Korean patients.…”

Sofosbuvir-based direct-acting antivirals for patients with decompensated hepatitis C virus–related cirrhosis

“…A subsequent multicenter study of 107 patients with Child-Pugh B or C cirrhosis reported SVR 12 rates in evaluable and per-protocol populations of 89.7% and 100%, respectively, with SOF/VEL plus RBV for 12 weeks. 4 In addition, in another study of the most difficult-to-treat population with combined liver and kidney failure who were treated with full-dose SOF/VEL and renally adjusted RBV for 12 weeks, the SVR 12 remained excellent under judicious monitoring. 5 In line with the findings of Su et al, patient tolerability was generally good and the causal relationship between SOF-based DAAs and severe adverse events was limited in our studies.…”

“…5 In line with the findings of Su et al, patient tolerability was generally good and the causal relationship between SOF-based DAAs and severe adverse events was limited in our studies. [2][3][4][5] This is particularly relevant for patients with decompensated HCV-related cirrhosis because a shortage of organs limits accessibility to transplantation. Although a significant proportion of patients with SVR 12 have improved Child-Pugh and model for end-stage liver disease scores, a short-term state of score "purgatory" does not necessarily reflect long-term clinical improvement, and hence prudent surveillance is needed to secure long-term outcomes.…”

HCV Infection and Liver Cirrhosis Are Associated with a Less-Favorable Serum Cholesteryl Ester Profile Which Improves through the Successful Treatment of HCV

“…Most of the patients followed for up to four years after treatment with DAAs had only marginal improvements of the MELD score, showing that liver dysfunction persists [ 8 , 9 ]. It was also reported that about 30% of patients had an improved MELD score ≥ 3 at sustained virologic response rates at off-treatment week 12 when treated with sofosbuvir/velpatasvir plus ribavirin [ 10 ]. Notably, DAA therapy is similarly effective in HCV patients with and without liver cirrhosis [ 10 , 11 ].…”

“…It was also reported that about 30% of patients had an improved MELD score ≥ 3 at sustained virologic response rates at off-treatment week 12 when treated with sofosbuvir/velpatasvir plus ribavirin [ 10 ]. Notably, DAA therapy is similarly effective in HCV patients with and without liver cirrhosis [ 10 , 11 ].…”