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 ahepatitis C virus (HCV) elimination program in place since 2015,there have been limited studies investigating the effectivenessand safety ofdirect-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 HCVcases in Saudi Arabia as per the MOH data from 2017 to 2021. Methods This was a retrospective cohort study involving recorded HCVcases in the national hepatitis surveillance database of MOHacross all regions of KSAfrom 2017to 2021. Statistical analyses were performed using IBM SPSS Statistics software (IBM Corp., Armonk, NY). Continuous variables were expressed asmean ± 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 Regardingdemographic characteristics, age was significantly associated with HCVinfection (p=0.002).Similarly, nationality had a highly significant association with HCVinfection (p=0.004). Regardingclinical characteristics, creatinine levels were significantly associated with HCVinfection (p=0.009). As for effectiveness, all participantshad a positivepolymerase chain reaction(PCR) for HCVat enrolment(n=4806) and were DAAS-naïve. After the completion of the first DAAScourse, 99.5%(4781) had negative PCRs12 weeks post-treatment completion; however, the PCRremained positive for some patients (0.5%, n=25), which became negative after receiving the second DAAScourse, resulting in complete cure of HCV infection and a 100% negative PCRamong all participants. With regard to safety, noside 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 HCVinfection. However, only nationality showed a significant association with HCVinfection 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 HCVin Saudi Arabia.