Chronic Hepatitis C: Do Generics Work as Well as Branded Drugs?

Abstract

India has a large share of the hepatitis C virus (HCV) burden of the world. Unsafe medical practices and blood transfusions are the leading modes of transmission of HCV in India. The commonest HCV genotype in India is genotype 3 followed by genotype 1. While directly acting antivirals (DAAs) agents have become available at reasonable rates in India, cost of therapy remains a major barrier for control of HCV in India. Generic DAAs have been proven to be cost-saving in prior studies. We examined data from various studies in India and elsewhere using generic DAAs, and evaluated whether they are equally efficacious as the branded drugs. Since the availability of generic DAAs in the Indian market, there is a lot of real life data as well as prospective studies in special patient populations such as hematological disorders (thalassemia and hemophilia), chronic kidney disease, hemodialysis patients, post liver and renal transplant patients on immunosuppression, intravenous drug users, confections and other high risk groups. Control of HCV infection in India requires multi pronged approach. There is a need to formulate a health educational curriculum targeting not only the high-risk population but also the general population regarding the transmission of HCV. Adopting the dual approach of treating the old cases (decreasing the reservoir pool of HCV) and decreasing the incidence of new ones would help curtail the disease and decrease liver related mortality. In this scenario, the role of efficacious low cost generic medications is essential.

High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C

“…Omar et al (2018) showed that among 18,378 patients with HCV-G4 treated within the Egyptian national program with generic SOF-DCV, the SVR rate was 95.1%. Similar high SVR rates were presented in other reports for SOF-LDV (Zeng et al, 2017;Gupta et al, 2018), and for SOF-Velpatasvir (Liu et al, 2018), including patients co-infected with HIV (Premkumar et al, 2017). The largest real-life report for treatment of HCV with generic drugs came from the Egyptian national HCV treatment program, where 98.4% of 107,213 patients treated with generic SOF-DCV achieved an SVR (Elsharkawy et al, 2018a).…”

Real-world cost-effectiveness of pan-genotypic Sofosbuvir-Velpatasvir combination versus genotype dependent directly acting anti-viral drugs for treatment of hepatitis C patients in the universal coverage scheme of Punjab state in India

“…For instance, the Punjab government launched the “ Mukh Mantri Punjab Hepatitis C Relief Fund (MMPHCRF)” for free universal treatment of HCV patients with DAAs and thus improve access to treatment. This has been possible due to the availability of generic DAAs which have significantly lesser cost as compared to the branded DAAs, at comparable efficacy [11]. The MMPHCRF scheme was launched in 2016 and uses the existing infrastructure of 22 secondary level district hospitals and 3 tertiary level medical colleges in Punjab to deliver HCV infection related treatment and care [12].…”

Systematic review: epidemiology and response to direct‐acting antiviral therapy in genotype 6 chronic hepatitis C virus infection

“…The regimen and the duration of treatment will have to be individualised to the region where generics are variably available and cost is a factor. In most countries in Asia, pangenotype generics are available and highly effective . The challenge, as we move forward is in identifying infected patients and treating them effectively while we attempt to reduce the burden of the costs of virologic testing and on treatment and post‐treatment follow‐up evaluation.…”