Ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin is safe and effective in HCV‐infected patients in a real‐life cohort from Latin America

Abstract

Information about the use of ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin (OBV/PTV/r/DSV ± RBV) in real-clinical practice in Latin America is scarce. We aimed to confirm safety and effectiveness of OBV/PTV/r/DSV ± RBV therapy in real-world setting. We analyzed a cohort of patients with genotype 1 infection treated with OBV/PTV/r/DSV ± RBV. Data on demographics, clinical features, safety, and virological response were retrospectively collected from 21 centers in Latin America. A total of 96 patients received OBV/PTV/r/DSV, associated with RBV in 68% of the cases. Most were genotype 1b (80%), 56 (58%) had cirrhosis, and 45 (47%) failed prior HCV treatment. Adverse events occurred in 62% of patients. The most common adverse events were pruritus (21%), hyperbilirubinemia (17%), and asthenia (17%). Five patients discontinued therapy prematurely due to hepatic decompensation, three of them were Child-Pugh B at baseline and one patient died due to multi-organ failure. Follow up HCV-RNA 12 weeks after completion of therapy was evaluated in all the patients and sustained virologic response rate was 97%. No virologic breakthrough was detected. Our study confirms that OBV/PTV/r/DSV treatment is highly effective in patients with chronic HCV without cirrhosis or with Child-Pugh A cirrhosis in non-European populations. Adverse events were often mild and rarely led to treatment discontinuation except for patients with Child-Pugh B cirrhosis or with previous history of hepatic decompensation. These results can support the development of public strategies to expand the access of OBV/PTV/r + DSV and other DAAs combinations in order to reduce the burden of HCV infection in our region.

Real‐world effectiveness and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without ribavirin for patients with chronic hepatitis C virus genotype 1b infection in Taiwan

“…At week 4 of treatment, the rate of serum HCV RNA level < LLOQ in our patients receiving PrOD‐based regimens was 98.0%, which was much higher than East Asian HCV‐1b patients receiving peginterferon plus RBV. After 12 weeks of off‐therapy follow‐up, the SVR 12 rate in our study was 98.1% and was comparable with the clinical trials and the published real‐world studies for HCV‐1b infected patients receiving the PrOD‐based regimens . In lines with the trial reports, we confirmed that the SVR 12 rates were comparable in our patients receiving PrOD‐based treatment, regardless of sex, age, prior treatment experience, HBsAg status, RBV usage, baseline HCV RNA levels, eGFR or stage of hepatic fibrosis .…”

“…Following the clinical trials reporting excellent efficacy and safety profiles, the real‐world data in Western HCV‐1b patients receiving PrOD with or without RBV for 12 weeks showed that the SVR 12 rates range from 87.6% to 98.9% . Regarding the real‐world data of PrOD‐based treatment in Asian patients, one report from Hong Kong evaluated 35 HCV‐1b patients receiving PrOD with or without RBV for 12–24 weeks.…”

Effectiveness and safety of original and generic sofosbuvir for the treatment of chronic hepatitis C: A real world study

“…Chronic hepatitis C is a major global health problem causing approximately 399 000 deaths per year according to recent estimates . Clinical trials and real‐world studies showed how direct‐acting antiviral agents (DAAs) dramatically improved hepatitis C cure rates even in patients with advanced liver disease . In Argentina, where the prevalence of hepatitis C is estimated to be 1.5‐2.5%, DAAs were first approved in 2015.…”

The ECHO model proved to be a useful tool to increase clinicians' self‐effectiveness for care of patients with Hepatitis C in Argentina

“…Our study also confirms that DAA regimens are highly effective in patients with chronic HCV with or without cirrhosis. Almost 450 patients were prospectively included in our analysis presenting high SVR rates, similar to what has been described in other real‐life cohorts from Latin America . The high safety and effectiveness of these drugs should support the deployment of public health strategies to expand the access to different DAA regimens in order to reduce the burden of HCV infection in our region.…”