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Efficacy and tolerability of ledipasvir/sofosbuvir on chronic hepatitis C virus patients attending viral hepatitis clinic at Benghazi medical center, Libya

Background: The prevalence of hepatitis C virus (HCV) infection in Libya is 1.3%. It is considered now a curable disease due to the availability of effective DAAs which open a new horizon for HCV elimination. The aim of this study was to evaluate the efficacy and tolerability of ledipasvir/sofosbuvir (LDV/SOF) (Harvoni) on patients with chronic hepatitis C infection. Patients and Methods: The cohort comprises 266 HCV-infected patients followed from May 2016 to October 2017. The inclusion criteria were treatment experienced or naïve and 18 years or older. Cirrhotic patients included were Child–Pugh A and B whereas Child–Pugh C patients were excluded. All patients had been treated with LDV/SOF 90/400 mg. The primary endpoint was sustained virological response (SVR) at week 12 and significant adverse events. Results: Of 266 patients who participated in the study, it's found that 126 were males(47.3%) and 140 were female (52.7%). The average age of the patients was 45 years for both genders. Ninety percent of patients were Libyan. The predominate genotype was 4 (81.3. %), genotype 1 (15.3%), and genotype 2 (3.2%). One hundred and seventy-eight (66.9%) patients were treatment naïve and 88 (33.1%) patients were treatment experienced. Alanine aminotransferase elevated in 37% of patients at baseline. HCV RNA >5 log at the start of treatment was found in 67.2% of patients. Eighty-eight patients were cirrhotic. The adverse effects of the drug were reported in 38/266 (14.2%); the most commonly reported side effects were headache, gastrointestinal upset, and dizziness, whereas hepatic decompensation occurred in 5 patients and all were cirrhotic. Undetectable viremia at the end of treatment (week 12) was observed in 263 patients (98.5%) and 3 patients have been labeled as nonresponders. SVR at week 12 was available in 263 patients and achieved in 261 patients (98.1%), and only two relapsed. Conclusion: Excellent treatment outcomes among our cohort of HCV-infected patients were achieved with LDV/SOF. Testing for chronic HCV patients and availability of care will help in cure and a step toward eradication of HCV in near future.