4 research outputs found
Impact of Comorbidities and Comedications on the Effectiveness of Ombitasvir/Paritaprevir/Ritonavir +/- Dasabuvir +/- Ribavirin in Clinical Practice: Real-World Evidence From a Multicountry Postmarketing Observational Study
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1-and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries
International audienceOmbitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) regimens show high efficacy and good tolerability in clinical trials for chronic hepatitis C virus (HCV) genotypes (GT) 1 or 4. To evaluate whether these results translate to clinical practice, data were pooled from observational studies across 13 countries. TreatmentânaĂŻve or âexperienced patients, with or without cirrhosis, received OBV/PTV/r ± DSV ± RBV according to approved local labels and clinical practice. Sustained virologic response at postâtreatment Week 12 (SVR12), adverse events (AEs) and comedication management were assessed for patients initiating treatment before 1 June 2017. The safety population included 3850 patients who received â„1 dose of study drug. The core population (N = 3808) further excluded patients with unknown GT or cirrhosis status, or who received offâlabel treatment. Patients had HCV GT1a (n = 732; 19%), GT1b (n = 2619; 69%) or GT4 (n = 457; 12%). In 3546 patients with sufficient followâup data at postâtreatment Week 12, the SVR12 rate was 96% (n/N = 3401/3546 [95% CI 95.2â96.5]). In patients with or without cirrhosis, SVR12 was comparable (96%). In patients with HCV GT1a, GT1b or GT4, SVR12 rates were 93%, 97% and 94%. In GT1bâinfected patients with planned treatment for 8 weeks, SVR12 was 96%. In patients with â„1 comorbidity (67%), SVR12 was 95%. 58% of patients received â„1 comedication, and there was minimal impact on SVR12 rates using comedications for peptic ulcers and gastroâesophageal reflux disease, statins, antipsychotics or antiepileptics. Most comedications were maintained during treatment although 58% of patients changed their statin medication. AEs and serious AEs occurred in 26% and 3% of patients. Postâbaseline Grade 3â4 laboratory abnormalities were rare (<3%), and discontinuation rates were low (<4%). Realâworld evidence confirms the effectiveness of OBV/PTV/r ± DSV ± RBV in patients with HCV GT1 or GT4, regardless of common comorbidities or comedications, and is consistent with clinical trial results. Adverse safety outcomes may be limited by underreporting in the realâworld setting
Effect of Hepatitis C Treatment with Ombitasvir/Paritaprevir/R + Dasabuvir on Renal, Cardiovascular and Metabolic Extrahepatic Manifestations: A Post-Hoc Analysis of Phase 3 Clinical Trials
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