Importation of generic hepatitis C therapies: Bridging the price - access gap in high-income countries

Abstract

The global burden of hepatitis C infection and the emergence of effective therapies An estimated 80-150 million people are infected with hepatitis C infection (HCV) worldwide, with the highest prevalence rates in low- and medium-income countries of Africa and Asia. HCV-related liver disease mortality is estimated to be half a million per annum.1,2 Chronic HCV treatment was interferon-based for two decades, with the addition of ribavirin (RBV),3 pegylated-interferon (PEG-IFN)4 and initial protease inhibitor direct acting antiviral (DAA) therapies (telaprevir, boceprevir)5,6 subsequently providing stepwise improvements in the rate of sustained virological response (SVR). Despite these improvements, interferon-containing HCV therapy uptake remained low in most countries, ranging from <1% to a maximum of 5% of people with chronic HCV initiating therapy each year.7 Fortunately, recent years have seen a revolution in HCV therapeutic development, with the advent of interferon-free DAA therapies, which disrupt replication through inhibition of HCV protease, polymerase and NS5A function.8 Simple (single daily dosing oral regimens), highly tolerable, short-duration (8-24 weeks) regimens with extremely high efficacy (cure rates above 95%) have been developed and registered internationally. Used in various combinations depending on HCV genotypes and previous treatment exposure, these include: sofosbuvir/ledipasvir ,9-11 paritaprevir/ritonavir/ombitasvir/dasabavir/+/-ribavirin ,12-14 sofosbuvir/daclatasvir,15,16 elbasvir/grazoprevir,17,18 and sofosbuvir/velpatasvir. There is clear evidence that HCV cure impacts HCV-related liver disease and hepatocellular carcinoma (HCC) risk.19 Early treatment may have greater benefit. Furthermore, as a result of the high efficacy and tolerance, and ease of delivery of these medications, HCV treatment as prevention is being explored in some countries, particularly treating high prevalence populations, such as people who inject drugs and incarcerated populations.20 The broad implementation of these therapeutic regimens has the potential to dramatically impact HCV-related disease burden globally. Indeed, new HCV treatments have been deemed so important that some (sofosbuvir, daclatasvir) were added to the 2015 WHO Essential Medicines List along with a number of their combinations.