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

Abstract

SummaryOmbitasvir/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. Treatment‐naïve or ‐experienced patients, with or without cirrhosis, received OBV/PTV/r ± DSV ± RBV according to approved local labels and clinical practice. Sustained virologic response at post‐treatment 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 ≥1 dose of study drug. The core population (N = 3808) further excluded patients with unknown GT or cirrhosis status, or who received off‐label treatment. Patients had HCV GT1a (n = 732; 19%), GT1b (n = 2619; 69%) or GT4 (n = 457; 12%). In 3546 patients with sufficient follow‐up data at post‐treatment Week 12, the SVR12 rate was 96% (n/N = 3401/3546 [95% CI 95.2‐96.5]). 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 GT1b‐infected patients with planned treatment for 8 weeks, SVR12 was 96%. In patients with ≥1 comorbidity (67%), SVR12 was 95%. 58% of patients received ≥1 comedication, and there was minimal impact on SVR12 rates using comedications for peptic ulcers and gastro‐esophageal 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. Post‐baseline Grade 3‐4 laboratory abnormalities were rare (<3%), and discontinuation rates were low (<4%). Real‐world 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 real‐world setting.

Glecaprevir/pibrentasvir is safe and effective in hepatitis C patients with cirrhosis: Real‐world data from the German Hepatitis C‐Registry

“…Overall, the characteristics of patients in the current study were similar to those observed internationally and within Germany, with most patients having HCV GT1 or GT3. 1,12,13 Most patients in the in comparison with other G/P or PI studies, 6,[13][14][15][16][17][18][19] G/P is not an appropriate treatment option for patients with decompensated cirrhosis because it is either not recommended or contraindicated for patients with Child-Pugh B and contraindicated in patients with Child-Pugh C. 5,9 Alternative DAA regimens are now available for the treatment of patients with HCV and advanced liver disease. 8 G/P remains an important treatment option for patients without cirrhosis or with CC.…”

“…Similarly, high rates of SVR12 have been observed with other DAAs, including other PI-containing regimens in real-world settings, even among patients with cirrhosis, although many of these studies are limited by analysis of only 1 or 2 GTs. 6,14,15,[17][18][19]…”

Liver Transplantation and HCV Genotype 4

“…The combination of ombitasvir, ritonavir and paritaprevir was evaluated in multiple studies involving compensated cirrhotic HCV-G4 patients and revealed high SVR rates reaching 100% in some studies [119][120][121][122][123][124]. In a recent meta-analyses, 20 cohorts across 12 countries were identified, totaling 5158 patients infected with Liver Transplantation and HCV Genotype 4 DOI: http://dx.doi.org/10.5772/intechopen.95831 G1 and 4.…”

Liver cT1 decreases following direct-acting antiviral therapy in patients with chronic hepatitis C virus

“…Chronic hepatitis C virus (HCV) affects an estimated 71 million people worldwide [1] and is associated with the development of liver cirrhosis, hepatocellular carcinoma (HCC), liver failure and death. Direct-acting antiviral therapies (DAAs) have high rates of viral eradication (> 95%) and have transformed the treatment of HCV [2][3][4][5][6][7][8][9][10][11][12].…”