The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia

Sumaiah J Alarfaj; Abdullah Alzahrani; Anfal Alotaibi; Malak Almutairi; Mashael Hakami; Njood Alhomaid; Noori Alharthi; Ghazwa B Korayem; Abdullah Alghamdi

doi:10.1016/j.jsps.2022.07.005

The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia

Saudi Pharm J. 2022 Oct;30(10):1448-1453. doi: 10.1016/j.jsps.2022.07.005. Epub 2022 Jul 25.

Authors

Sumaiah J Alarfaj¹, Abdullah Alzahrani², Anfal Alotaibi¹, Malak Almutairi¹, Mashael Hakami¹, Njood Alhomaid¹, Noori Alharthi¹, Ghazwa B Korayem¹, Abdullah Alghamdi³

Affiliations

¹ Department of Pharmacy Practice, College of Pharmacy, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.
² Department of Pharmacy, Security Forces Hospital, Riyadh, Saudi Arabia.
³ Internal Medicine Department, Security Forces Hospital, Riyadh, Saudi Arabia.

Abstract

Background: The introduction of direct-acting antivirals (DAA) to treat the hepatitis C virus (HCV) overcame many drawbacks of interferon-based therapy. DAA achieved sustained viral response (SVR) rates above 90% and overcame many drawbacks of pegylated interferon regimens.The HCV genotype (GT) distribution varies by geographical area, with GT-4 being most prevalent in the Middle East region, including Saudi Arabia. Yet, the real-world evidence about using DAAs in the Saudi population is limited.Thus, the aim of this study to investigate the effectiveness and safety of DAAs in Saudi patients with HCV infection.

Methods: A retrospective cohort study included patients treated with DAAs from 2015 to 2017 at a tertiary care hospital in Riyadh, Saudi Arabia. All patients with HCV treated with either ledipasvir plus sofosbuvir (LDS/SOF) ± ribavarin (RBV) or ombitasvir-paritaprevir-ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± RBV were included. Using a per-protocol analysis, the effectiveness outcome was the end-of-treatment response (EOTr) and Sustained virologic reponce12 weeks after competing the regimen (SVR12). The secondary safety outcome was the adverse event related to the therapy reported by the patients.

Results: A total of 97 patients were included; with the majority infected with GT-4 (64 %), followed by GT-1 (18 %), in addition to 8 % having a mixed GT (1 + 4). The EOTr and SVR12 rates were 98 % and 96 %, respectively. SVR12 was 94.4 % within the LDS/SOF ± RBV group and 97.7 % within the OBV/PTV/r ± DSV ± RBV group. Only 4 % had a response failure due to relapse or breakthrough, and all were infected with mixed GT1 + 4. Medications were well tolerated with minimal side effects, including vomiting, nausea, and weakness.

Conclusion: DAAs regimens are associated with high rates of SVR12 and are well tolerated with a good safety profile in Saudi HCV-infected patients.

Keywords: DAA, direct-acting antiviral agent; DSV, dasabuvir; Direct-acting antivirals; Effectiveness; GT, genotype; Genotype 4; HCV, hepatitis C virus; Hepatitis C virus; LDV, ledipasvir; OBV, ombitasvir; PTV, paritaprevir; RBV, ribavirin; SOF, sofosbuvir; Saudi population; Sustained virologic response; r, ritonavir.