Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA‐C real‐world cohort

Abstract

Summary In randomized controlled trials of patients with chronic HCV infection, elbasvir/grazoprevir (EBR/GZR) demonstrated high cure rates and a good safety profile. This study assessed the effectiveness and safety of EBR/GZR, with and without ribavirin, in a real‐world HCV patient cohort. HEPA‐C is a collaborative, monitored national registry of HCV patients directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases. Patients entered into HEPA‐C between December 2016 and May 2017, and treated with EBR/GZR with at least end‐of‐treatment response data, were included. Demographic, clinical and virologic data were analysed, and adverse events (AEs) recorded. A total of 804 patients were included in the study. The majority were male (57.9%), with a mean age of 60 (range, 19‐92) years. Genotype (GT) distribution was GT 1, 86.8% (1a, 14.3%; 1b, 72.5%); GT 4, 13.2% and 176 patients (21.9%) were cirrhotic. Overall, among 588 patients with available data, 570 (96.9%) achieved sustained virologic response at 12 weeks post‐treatment (SVR12). SVR12 rates by genotype were GT 1a, 97.7%; GT 1b, 98.6%; and GT 4, 98.1%. No significant differences in SVR12 according to fibrosis stage were observed. Eighty patients experienced an AE, resulting in treatment discontinuation in three. In this large cohort of patients with chronic HCV managed in a real‐world setting in Spain, EBR/GZR achieved high rates of SVR12, comparable to those observed in randomized controlled trials, with a similarly good safety profile.

Effectiveness of Elbasvir/Grazoprevir in US Veterans with Chronic Hepatitis C Virus Genotype 1b Infection

“…SVR rates were generally unaffected by baseline characteristics, including presence of cirrhosis or history of hepatocellular carcinoma; however, the presence of NS5A resistance-associated substitutions, particularly in individuals who had previously received all-oral direct-acting antiviral therapy, was associated with virologic failure [18,19]. Similar results have also been reported in a Spanish cohort of patients with HCV genotype 1 infection, 73% of whom had genotype 1b infection [20]. In this analysis, of the 625 patients with data available at 12 weeks post-treatment, 570 (91.2%) achieved SVR12.…”

“…In the modified intention-to-treat analysis, which excluded 37 patients lost to follow-up, SVR12 was 96.9% (570/588). Among the patients with HCV genotype 1b infection, SVR12 rates remained C 96%, regardless of treatment history or presence of cirrhosis at baseline [20]. Data from the TRIO network in the United States further supports the high effectiveness of elbasvir/grazoprevir in patients with HCV genotype 1 infection in a real-world setting [21].…”

EASL recommendations on treatment of hepatitis C: Final update of the series☆

“…Sofosbuvir Tablets containing 400 mg of sofosbuvir One tablet once daily Half-strength tablets containing 200 mg of sofosbuvir a One tablet once daily Sofosbuvir/velpatasvir Tablets containing 400 mg of sofosbuvir and 100 mg of velpatasvir One tablet once daily Half-strength tablets containing 200 mg of sofosbuvir and 50 mg of velpatasvir a,b One tablet once daily Granules containing 50 mg of sofosbuvir and 12.5 mg of velpatasvir a,b Three or four granules once daily, according to body weight Sofosbuvir/velpatasvir/voxilaprevir Tablets containing 400 mg of sofosbuvir, 100 mg of velpatasvir and 100 mg of voxilaprevir One tablet once daily with food Glecaprevir/pibrentasvir Tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir Three tablets once daily with food Film-coated granules of glecaprevir and pibrentasvir in sachets containing 50 mg of glecaprevir and 20 mg of pibrentasvir mixed together in a small amount of food a,b Three to five sachets once daily, according to body weight The safety of elbasvir/grazoprevir is based on phase II and III clinical trials and real-world studies, with the most commonly reported adverse reactions being fatigue and headache. [46][47][48][49][50][51] Rare cases (0.8%) of substantial elevations in alanine aminotransferase (ALT) level were reported, slightly more frequently in female, Asian and elderly patients.…”

English hepatitis C registry data show high response rates to directly acting anti‐virals, even if treatment is not completed

“…Data on 14 603 patients with an established genotype who had completed treatment were retrospectively analysed making this one of the largest hepatitis C treatment cohorts evaluated globally 12,13 . Unlike other real‐world reports which describe experience with a single treatment regimen 12,14 or selected subpopulation (eg elderly patients 15 ), this cohort includes all patients and treatment options that have been available in England since 2014. Mandatory data collection through the national registry ensures that clinician‐generated patient selection bias is avoided.…”