The Effectiveness and Safety of Direct-Acting Antivirals in the Treatment of Hepatitis C Virus in Saudi Arabia: A Nationwide Study Based on the Saudi Ministry of Health Surveillance Data From 2017 to 2021

Abstract

Background and objective While the Kingdom of Saudi Arabia (KSA) has had a hepatitis C virus (HCV) elimination program in place since 2015, there have been limited studies investigating the effectiveness and safety of direct-acting antivirals (DAAS) based on the Ministry of Health (MOH) surveillance data. In light of this, this study was conducted to assess the effectiveness and safety of DAAS (glecaprevir/pibrentasvir, daclatasvir/sofosbuvir, or other combinations) in treating HCV cases in Saudi Arabia as per the MOH data from 2017 to 2021. Methods This was a retrospective cohort study involving recorded HCV cases in the national hepatitis surveillance database of MOH across all regions of KSA from 2017 to 2021. Statistical analyses were performed using IBM SPSS Statistics software (IBM Corp., Armonk, NY). Continuous variables were expressed as mean ± standard deviation (SD), and categorical variables were presented as numbers (percentages). An independent t-test was used for continuous variables, and a Chi-square analysis was used for categorical variables. A confidence interval of 95%, a margin of error of 0.05, a precision of 2%, and a 5% level of significance were employed. Results Regarding demographic characteristics, age was significantly associated with HCV infection (p=0.002). Similarly, nationality had a highly significant association with HCV infection (p=0.004). Regarding clinical characteristics, creatinine levels were significantly associated with HCV infection (p=0.009). As for effectiveness, all participants had a positive polymerase chain reaction (PCR) for HCV at enrolment (n=4806) and were DAAS-naïve. After the completion of the first DAAS course, 99.5% (4781) had negative PCRs 12 weeks post-treatment completion; however, the PCR remained positive for some patients (0.5%, n=25), which became negative after receiving the second DAAS course, resulting in complete cure of HCV infection and a 100% negative PCR among all participants. With regard to safety, no side effects were recorded in the cohort and hence the safety aspect was not analyzed. Conclusion Univariate analysis revealed that nationality (non-Saudi), age, and creatinine levels were significantly associated with HCV infection. However, only nationality showed a significant association with HCV infection following multivariate logistic regression adjustment. We believe that these insights will help guide the creation of clinical guidelines and promote evidence-based decision-making in the management of HCV in Saudi Arabia.

Keywords: direct-acting antivirals; effectiveness and safety; hepatitis c virus (hcv); kingdom of saudi arabia (ksa); ministry of health (moh).