Original Versus Generic Direct Acting Antivirals in Treatment of Chronic Hepatitis C Patients: Real Life Data From Latvia

Background: Despite effective treatment available from 2016 in Latvia, there are restrictions - only patients with fibrosis (F, Metavir) stage 3 to 4 have access to reimbursed medicines. Some patients obtain generic drugs from India. Objective: The aim of this study was to evaluate the efficacy of original and generic direct acting antiviral medications in Latvian patients. Materials and Methods: This is a retrospective study of 179 chronic virologic hepatitis C patients. Data were obtained from patients’ medical records. Mean age 49.2 years (SD 10.2, range 24-71), 88 female patients (49%), 91 male patients (51%). Genotype 1b was detected in 157 patients (87.7%). Patients were divided into two groups - patients who received original direct acting antivirals ombitasvir, paritaprevir, ritonavir, dasabuvir + ribavirin (n=144, F3-4, Child-Pugh A) and those who received generic medicines from India (n=35, F0-2) sofosbuvir, ledipasvir (n=7) or sofosbuvir, daclatasvir + ribavirin (n=28). Undetectable viral load 12 weeks after cessation of therapy (sustained virologic response 12 or SVR12) was measured in all patients. Therapy course completed 142 patients from original medicines group and all patients from generics group. Results: In the original medicines group - sustained viralogic response was achieved in 142 patients who completed treatment course (100%), while in generic medicines group in 32 patients (91.4%). Conclusion: Study results show high efficacy of both regimens using original and generic medicines - sustained virologic response was achieved in more than 90% of patients, with slight superiority in original medicines group.