Direct antiviral therapy in patients with HCV: evidence from Saudi Arabia
Published in Microbiology, Genetics & Genomics, and Public Health
It is well established that the primary goal of treatment for chronic hepatitis C is to achieve a sustained virologic response (SVR)—the absence of detectable hepatitis C virus RNA for at least 12 weeks (SVR12) or 24 weeks (SVR24)—and to reduce overall mortality and liver-related complications, including end-stage liver disease, hepatocellular carcinoma, and morbidity and mortality associated with extrahepatic manifestations of chronic hepatitis C virus infection. Achieving an SVR significantly reduces hepatic and extrahepatic complications associated with HCV, improves quality of life and prevents HCV transmission.
According to the latest data for 2016, approximately 0.5% of the Saudi population was actively infected with hepatitis C, of which approximately 20% had been previously diagnosed, and approximately 50% of these patients had been treated. Furthermore, 50% of treated hepatitis C patients were cured with standard therapy using pegylated interferon and ribavirin. An additional 5,000 people were treated with new direct-acting antiviral (DAA) drugs, with a cure rate of >90%.
In this study, we aimed to evaluate the real-world outcomes of treating Saudi patients infected with HCV with DAAs as part of a national campaign to eliminate this disease in Saudi Arabia. Unlike previous reports, we aimed to provide complete follow-up data (SVR12 and SVR24) and identify proportion of unspecified genotypes, which would contribute to understanding current diagnostic and therapeutic options in clinical practice.
The study included a sample of 144 Saudi patients infected with hepatitis C virus who were treated as outpatients and received DAA therapy between January 2016 and December 2023. All patients completed therapy and achieved SVR at 12 and 24 weeks. We attributed this to strict adherence monitoring, free therapy under the national program, and comprehensive follow-up protocols that minimized treatment discontinuations.
The most common genotype was GT4 (38.9%), followed by GT1(a and b) (20.1%). We also referenced previous studies describing the regional distribution of HCV genotypes and thus hypothesized that GT4 is the dominant genotype in Middle Eastern countries. In addition to examining known HCV genotypes, we also discovered a novel pattern in the Saudi population: of n = 144 patients, n = 42 (29.2%) had an unknown genotype. To our knowledge, this is the first study to report such a large proportion of cases with an unknown genotype. However, since this study was retrospective, we proposed further study of this genotype in prospective genetic studies.
Another finding that requires further study in prospective studies was that despite successful completion of the treatment course with 100% sustained virologic response, resulting in a significant reduction in mean liver enzyme levels—alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase (ALP)—the level of conjugated bilirubin did not change.
With the World Health Organization projecting a 90% reduction in new hepatitis cases and a 65% reduction in deaths between 2016 and 2030, these emerging data from Saudi Arabia are worth considering. We believe that new studies should consider a thorough investigation of unknown genotypes and examination of associated risk factors that may lead to liver fibrosis, as well as the association of age and gender with HCV genotypes with the inclusion of a larger population. Moreover, research based on these data will provide a deeper understanding of the effectiveness and durability of treatments, which may not only improve patient care but also inform health policy and recommendations, ultimately leading to improved health outcomes.
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BMC Infectious Diseases
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