Direct-acting antivirals for chronic hepatitis C infection: a protocol for a systematic review of observational studies
Abstract
Chronic hepatitis C virus infection presents a substantial global health burden, frequently resulting in severe liver conditions. Hepatitis C virus (HCV) therapy requires complex decision-making. Direct-acting antivirals (DAAs) offer a potential solution by targeting viral proteins to inhibit replication. Understanding DAAs real-world effectiveness and how they impact long-term outcomes beyond clinical trials is essential. We aim to comprehensively evaluate the benefits and harms of DAAs in individuals with chronic HCV infection, reported in observational studies. We will consider for inclusion prospective and retrospective observational studies with quasi-randomised, cohort, case–control, controlled before-and-after, and cross-sectional designs. Our experimental interventions will be any class of DAAs available on the market or in development. DAAs could have been administered alone, in combination, or with other medical co-interventions. Our control interventions will be untreated chronic HCV conditions, with or without placebo. Participants will be adults, regardless of demographics, treatment history, or healthcare setting. Our primary outcomes will be participants experiencing hepatitis C-related morbidity or all-cause mortality, serious adverse events, and health-related quality of life. Secondary outcomes will include all-cause mortality, cirrhosis, variceal bleeding, hepato-renal syndrome, hepatocellular carcinoma, hepatic encephalopathy, non-serious adverse events,…
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Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
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