SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience

Abstract

Background and objectives The pangenotypic single tablet regimen of NS5B inhibitor sofobuvir (SOF) and NS5A inhibitor velpatasvir (VEL) is advised for 12 weeks in HCV-infected patients including those with compensated cirrhosis. Addition of ribavirin (RBV) may be considered in genotype 3 (GT3) with compensated and is recommended in decompensated cirrhosis. Real-life results with SOF/VEL are limited. To evaluate efficacy and safety in a large real-world-cohort including patients with different GTs and various fibrosis stages. Design In total, 1429 patients were treated with SOF/VEL 400/100 mg for 12 weeks in the Puglia registry between June 2017 and May 2018. 1319 (92.3%) reached week 12 post-treatment (SVR12) at the moment. Only 41 received RBV. Diagnosis of cirrhosis was based on transient elastography and/or APRI or FIB-4 scores. Sensitivity analysis in the population including all patients except non virological failure was conducted. Primary efficacy endpoint was the percentage of patients with SVR12. Results Patients’ mean age was 63.8 years, 42.3% had GT1. The majority were naïve and 735 (55.5%) F0/F2. Of the remaining 587, 282 had cirrhosis. SVR12 was 98.5%, 98.0% in GT1, 99.4% in GT2, 97.1% in GT3, 100% in GT4. Overall, SVR12 by sensitivity analysis was 99.4%; 99.7% among F0-F1. Among 218 PWID, SVR12 was 94.5%. Discontinuation rates were 3.7% among PWID and 0.7% among non-PWID (p = 0.004). Conclusions SOF/VEL treatment of chronic HCV infection reaches very high cure rates in a variety of patients; including those with F0/F1 and PWID.

Global real‐world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts

“…Several real-world cohorts have evaluated SOF/VEL effectiveness and safety in varying settings, with the results being similar to those of clinical trials. 10,[15][16][17][18][19][20][21][22][23][24] In this integrated real-world analysis, data from 12 clinical practice cohorts across different real-world settings in Canada, Europe and the USA were pooled to allow the evaluation of the real-world effectiveness of SOF/VEL for 12 weeks without ribavirin (based on the label or physician discretion) in the largest available heterogeneous HCV patient population and to investigate any patient characteristics affecting the risk of not achieving SVR. (Table 1)…”

Comparison of three therapeutic regimens for genotype‐3 hepatitis C virus infection in a large real‐life multicentre cohort

“…In the face of an abundance of literature on different single regimens to treat HCV‐GT3, direct comparisons among different regimens are limited . Treatment recommendations are based on small, non‐randomized trials or on comparisons with suboptimal and currently dismissed regimens (ie SOF + RBV, or SOF + pegylated interferon + RBV), with HIV coinfection and cirrhosis being often underrepresented.…”

“…4 The combination of SOF + daclatasvir (DAC), though not included in the latest guidelines, have been widely used in recent years, either in clinical trials [9][10][11] or in real life, [12][13][14][15][16] and has been the benchmark treatment for HCV-GT3 in cirrhotic patients, where it was used for 24 weeks, often with the addition of RBV. 11,[14][15][16] In the face of an abundance of literature on different single regimens to treat HCV-GT3, [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] direct comparisons among different regimens are limited. [34][35][36][37] Trying to get through this lack of data, we aimed at comparing sustained virological response (SVR) rate of these three different regimens for HCV-GT3 in a large real-life cohort.…”

HCV Infection in Thalassemia Syndromes and Hemoglobinopathies: New Perspectives

“…The eradication of the virus determined by the new drugs has also led to a marked improvement in the parameters of martial accumulation, demonstrating a synergic action also between the effect of antiviral therapy and iron chelation (Dharamsi et al, 2017;Nagral et al, 2017;Origa et al, 2017;Premkumar et al, 2017;Mehta et al, 2018;Mangia et al, 2019;Ponti et al, 2019).…”

“…Several trials have been performed on thalassemia patients, while few studies focused on safety, tolerability and efficacy of LDV/SOF treatment for patients with SCD (Moon et al, 2017). The development in recent years of highly effective and increasingly selective DAAs toward different viral genotypes has led to a real revolution in the HCV eradication for patients with thalassemia and hemoglobinopathies, leading to negative viremia and SVR between 90 and 98% (Materazzi et al, 2014b(Materazzi et al, , 2017bNagral et al, 2017;Origa et al, 2017;Mehta et al, 2018;Premkumar and Dhiman, 2018;Mangia et al, 2019;Ponti et al, 2019).…”