Original Versus Generic Direct Acting Antivirals in Treatment of Chronic Hepatitis C Patients: Real Life Data From Latvia
Ieva Tolmane1, 2, *, Baiba Rozentale2, 3, Seda Arutjunana1, Agita Jeruma2, 4, Velga Kuse1, 2, Raimonds Simanis4
Identifiers and Pagination:Year: 2018
First Page: 63
Last Page: 70
Publisher Id: TOIDJ-10-63
Article History:Received Date: 26/03/2018
Revision Received Date: 6/06/2018
Acceptance Date: 12/06/2018
Electronic publication date: 29/06/2018
open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.
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.
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%).
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.