Generic Hepatitis C Treatments May Lower Costs with Equal Efficacy

A recent study suggests the efficacy of generic versions of sofosbuvir, ledipasvir, daclatasvir, and ribavirin may be equivalent to branded combination treatments.

In a study presented at The International Liver Congress 2016, patients with hepatitis C virus (HCV) received legally imported generic HCV treatments in Australia, United States, UK, Canada, Europe, South East Asia, and Africa.

In Australia, generic direct-acting antivirals (DAAs) were tested for quality using liquid chromatography, nuclear magnetic resonance, and mass spectroscopy.

Patients were assessed before and after treatment, as well as at week 4 to assess sustained virologic response (SVR4) and week 12 (SVR12).

The researchers found the SVR rate was 95% for patients with genotype 1. Patients treated with generic sofosbuvir and ledipsavir had SVR4 rates of 93%, while patients treated with generic sofosbuvir and daclatasvir had SVR4 rates of 97%.

"Across all genotypes, the SVR rate was 94% after treatment with generic DAAs. This indicates that generic DAAs can deliver the same success rates as branded equivalents, but at a price which is 1/100th of the current cost," said James Freeman, BSc and MB, BS, lead author of the study.

Currently, the branded DAAs prevent many people throughout the world from receiving treatment. With generics, the treatments could potentially cost as little at $1000 per person, according to the study.

"There is a clear role for generic treatments such as these for people with Hepatitis C across the world,” said Laurent Castera, MD, PhD, EASL Secretary General. “The implications of increased availability of these drugs could be enormous, presenting more people with the possibility of a 'cure' for what is often a debilitating condition.”