Generic direct acting antivirals in treatment of chronic hepatitis C patients


This article by Dr. Ieva Tolmane et al. is published in The Open Infectious Diseases Journal, Volume 10, 2018

There has been published results of the study "ORIGINAL VERSUS GENERIC DIRECT ACTING ANTIVIRALS IN TREATMENT OF CHRONIC HEPATITIS C PATIENTS: REAL LIFE DATA FROM LATVIA" authored by Tolmane I, Rozentale B, Arutjunana S et al., recently.

There are many new highly effective direct acting antiviral medicines for hepatitis C treatment registered worldwide during recent years. Despite effective treatment available from 2016 in Latvia, there are restrictions - only patients with fibrosis (F, Metavir) stages 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 hepatitis C patients. This was a retrospective study of 179 chronic viral hepatitis C patients. Patients were divided into two groups - those who received original direct acting antivirals ombitasvir, paritaprevir, ritonavir, dasabuvir + ribavirin (n=144) and those who received generic medicines from India (n=35) sofosbuvir, ledipasvir or sofosbuvir, daclatasvir + ribavirin. Undetectable viral load 12 weeks after cessation of therapy (sustained virologic response 12) was measured in all patients. Therapy course completed 142 patients (2 patients discontinued treatment) from original medicines group and all patients from generics group. In the original medicines group - sustained viral response was achieved in all 142 patients who completed treatment course (100%), while in generic medicines group in 32 patients (91.4%).

Study results showed 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. This study shows patient's interest and eligibility to seek for alternative treatment possibilities, when original drugs are not available through reimbursement system, and they are too expensive to buy out of pocket. This study also shows high efficacy of generic drugs obtained from India.

Reference: Tolmane L et al, (2018). Original Versus Generic Direct Acting Antivirals in Treatment of Chronic Hepatitis C Patients: Real Life Data From Latvia. The Open Infectious Diseases Journal, Volume 10, 2018. DOI: 10.2174/1874279301810010063

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