Sustained virological response to ombitasvir/paritaprevir/ritonavir and dasabuvir treatment for hepatitis C: Real‐world data from a large healthcare provider

Abstract

Treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin (OPrD ± RBV), was the first interferon-free direct-acting antiviral for hepatitis C virus (HCV) introduced to Israel's national basket of health services in February 2015. Patients with HCV genotype 1 (GT1) and advanced fibrosis (F3-F4) were eligible for treatment in 2015. This study aimed to characterize patients initiating OPrD ± RBV and assess sustained virological response (SVR). A retrospective cohort study was performed using the database of Maccabi Healthcare Services (MHS), a 2-million-member health plan in Israel. The study population included adults who initiated OPrD ± RBV through December 2015 per health basket criteria. A gap in medication fills (>14 days between a fill's run-out and the next fill) was used to estimate adherence. SVR was defined by the viral tests at least 12-week post-treatment. The study population consisted of 403 patients (56.3% male), with a mean age of 60.7 years (SD 11.0). Overall, 71.0% were naïve to prior HCV treatment, and 95.6% were treated with a 12-week regimen. A total of 348 patients (86.4%) completed the regimen in the usual time frame (highly adherent), whereas 8.2% completed with a gap, and 4.7% purchased less than the recommended dose. SVR rates overall and among highly adherent patients were 395/403 (98.0%; 95% CI 96.1-99.1) and 346/348 (99.4%; 95% CI 97.9-99.9), respectively. GT1b patients on 12-week regimens attained SVR rates of 194/196 (fibrosis F3) and 170/176 (cirrhosis). After a first year of provision of OPrD ± RBV with good adherence, high SVR rates were achieved in various patient subgroups and comorbidities.

Real‐world outcomes of unrestricted direct‐acting antiviral treatment for hepatitis C in Australia: The South Australian statewide experience

“…Importantly, the potential of “missing” virological failure in those LTFU does have onward implications for persistent transmission and eventual eradication of HCV. Amongst the current real‐world literature, missing SVR data ranges between 2 and 9% in larger observational studies . Elsharkawy et al (2001) report the highest level of loss to follow‐up at 29% in a large observational study of 20 324 genotype 4 patients completing DAA therapy in Egypt .…”

Treatment of hepatitis C: Results in real life

“…The ombitasvir/paritaprevir/ritonavir plus dasabuvir combination regimen has been evaluated in many large‐scale real‐world studies and reported consistently high SVR rates with 12‐24 weeks of treatment. In a real‐world study of genotype 1‐infected patients with advanced fibrosis (F3‐F4), the overall SVR rate was 98% (395/403) with this combination . Furthermore, an SVR rate of 97% (170/176) was reported in a subset of more difficult patients (genotype 1b with cirrhosis) .…”

“…In a real-world study of genotype 1-infected patients with advanced fibrosis (F3-F4), the overall SVR rate was 98% (395/403) with this combination. 13 Furthermore, an SVR rate of 97% (170/176) was reported in a subset of more difficult patients (genotype 1b with cirrhosis). 13 Real-world data from Germany, Spain and Israel have also reported high SVR rates of 96% (n = 892), 96.8% (n = 1567) and 98.8% (n = 416), respectively in patients with genotype-1 infection receiving this regimen.…”

“…13 Furthermore, an SVR rate of 97% (170/176) was reported in a subset of more difficult patients (genotype 1b with cirrhosis). 13 Real-world data from Germany, Spain and Israel have also reported high SVR rates of 96% (n = 892), 96.8% (n = 1567) and 98.8% (n = 416), respectively in patients with genotype-1 infection receiving this regimen. [14][15][16] In the German cohort, 14 The combination of sofosbuvir plus simeprevir (± ribavirin) is an alternative to sofosbuvir plus daclatasvir that is not currently recommended in patients with genotype 1 infection (Table 1).…”

Renal safety in 3264 HCV patients treated with DAA-based regimens: Results from a large Italian real-life study

“…Worldwide, 71 million people are chronically infected with the hepatitis C virus (HCV) [1]. Direct-acting antivirals (DAA) provided high sustained virological response (SVR) rates in reallife cohorts [2][3][4], without major safety signals [5][6][7][8][9][10][11][12][13]. Most of these studies have excluded patients with chronic kidney disease (CKD) as Sofosbuvir (SOF) is not recommended in patients with an estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m 2 [14,15].…”