Effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir for hepatitis C virus in clinical practice: A population-based observational study

Abstract

BackgroundDirect acting antivirals for hepatitis C virus have shown dramatic results in clinical trials. However, their effectiveness has yet to be demonstrated within observational cohorts which lack exclusion criteria found in randomized control trials.AimTo determine the effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir in achieving sustained virological response.MethodsRetrospective observational cohort study of all Clalit Health Services members with hepatitis C virus genotype 1 who were dispensed dasabuvir/ombitasvir/paritaprevir/ritonavir from January 1, 2015 to-November 31, 2015.ResultsThere were 564 participants during the study period. The average age was 61.9 years, 52.0% were male, and 61.5% were born Eastern/Central Europe or Central Asia. The prevalence of diabetes was 31.7% and 70.3% were overweight/obese. Cirrhosis was present in 41.0% of participants, of whom 52.8% had stage 4 fibrosis. Of the cohort, 416 (74.8%) had follow-up viral load testing at 10 or more weeks after the end of treatment. We report a sustained virological response of 98.8% among those tested.ConclusionsTreatment with dasabuvir/ombitasvir/paritaprevir/ritonavir demonstrated a near universal effectiveness in achieving a sustained virological response among HCV patients in a large cohort.

Loss to follow‐up: A significant barrier in the treatment cascade with direct‐acting therapies

“…Overall, irrespective of treatment duration, the OBV/PTV/r + DSV regimen showed high effectiveness with an overall 99.5% SVR rate among individuals with cirrhosis (SVR = 100.0%) and without cirrhosis (SVR = 99.5%). These findings are consistent with previously reported clinical trials and data from real‐world studies, as the majority (93.2%) of individuals in this group were infected with GT1b and only 10.6% were treatment experienced.…”

Treatment of hepatitis C: Results in real life

“…Furthermore, an SVR rate of 97% (170/176) was reported in a subset of more difficult patients (genotype 1b with cirrhosis) . 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 . In the German cohort, analysis of response across subgroups showed consistently high SVR rates: 95% in patients with cirrhosis (n = 123/129), 100% in those with moderate to severe renal impairment (n = 34/34) and 96% in subgroups that are usually excluded from clinical trials (including patients ≥70 years old [n = 64/67] and prior failures to protease inhibitor treatment [n = 46/48]).…”

“…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). This recommendation is based on lower cure rates than with other available regimens in most studies.…”

Expert Opinion on Managing Chronic HCV Infection in Patients with Type 2 Diabetes Mellitus

“…The introduction of IFN-free direct-acting antiviral (DAA) HCV therapies has dramatically improved at SVR post-treatment week 12 (SVR12) rates in both clinical trials and real-world studies [57], and realworld study data suggest high efficacy in patients with T2DM [58][59][60]. In a cohort study of 4365 HCV GT1-infected, treatment-naive US Veterans treated with ledipasvir and sofosbuvir with or without ribavirin (RBV), diabetes status did not impact SVR rates [58].…”