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The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia
Authors:Sumaiah J Alarfaj  Abdullah Alzahrani  Anfal Alotaibi  Malak Almutairi  Mashael Hakami  Njood Alhomaid  Noori Alharthi  Ghazwa B Korayem  Abdullah Alghamdi
Institution: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:BackgroundThe 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.MethodsA 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.ResultsA 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.ConclusionDAAs regimens are associated with high rates of SVR12 and are well tolerated with a good safety profile in Saudi HCV-infected patients.
Keywords:Hepatitis C virus  Direct-acting antivirals  Saudi population  Sustained virologic response  Genotype 4  Effectiveness  DAA"}  {"#name":"keyword"  "$":{"id":"k0040"}  "$$":[{"#name":"text"  "_":"direct-acting antiviral agent  DSV"}  {"#name":"keyword"  "$":{"id":"k0050"}  "$$":[{"#name":"text"  "_":"dasabuvir  LDV"}  {"#name":"keyword"  "$":{"id":"k0060"}  "$$":[{"#name":"text"  "_":"ledipasvir  SOF"}  {"#name":"keyword"  "$":{"id":"k0070"}  "$$":[{"#name":"text"  "_":"sofosbuvir  OBV"}  {"#name":"keyword"  "$":{"id":"k0080"}  "$$":[{"#name":"text"  "_":"ombitasvir  PTV"}  {"#name":"keyword"  "$":{"id":"k0090"}  "$$":[{"#name":"text"  "_":"paritaprevir  r"}  {"#name":"keyword"  "$":{"id":"k0100"}  "$$":[{"#name":"text"  "_":"ritonavir  RBV"}  {"#name":"keyword"  "$":{"id":"k0110"}  "$$":[{"#name":"text"  "_":"ribavirin  GT"}  {"#name":"keyword"  "$":{"id":"k0120"}  "$$":[{"#name":"text"  "_":"genotype  HCV"}  {"#name":"keyword"  "$":{"id":"k0130"}  "$$":[{"#name":"text"  "_":"hepatitis C virus
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