Hepatitis C : Introduction

HepatisC infection is caused by the Hepatitis C Virus (HCV). It is an emerging public health threat in a global scale. The Sustainable Development Goals (SDGs) adopted on 25 September 2015 recognize hepatitis as a global health issue to be tackled on an urgent basis.

Hepatitis is now one of the leading causes of death across the world and it is timely that the SDGs have recognized it as a major global health concern for which comprehensive health strategies need to be formulated and implemented and resources mobilized, nationally and internationally as a priority. Prevention of transmission, improving access to testing and treatment services and providing care and support services for those living with Hepatitis should be the focus of national responses to Hepatitis, particularly in high burden countries.

In 2014, HCV-related liver disease was reported to be the primary cause of death in the US. 2 It is also the leading cause of death in people co-infected with HIV. People living with HIV/HCV co-infection are at a greater risk for the progression of liver fibrosis but it is HCV, not HIV that is the cause of a significant number of deaths in co-infected people because while there are combination antiretroviral widely available to treat HIV, HCV testing and treatment remains out of reach for most who need it, even in high-income countries. PLHCV will continue to suffer without access to HCV prevention, testing, and treatment services unless immediate action is taken by policy-makers to address HCV. 1.2 HCV DISEASE PROGRESSION HCV infection may result in acute or chronic infection. Acute HCV infection is defined as the presence of HCV within six months of exposure. In 15–45% of individuals affected with acute infection the virus clears on its own 3 while the remaining proportion i.e. 55–85% 4 will carry HCV for the rest of their lives if not treated, and are considered to have chronic HCV infection. Those testing positive for anti-HCV antibodies must undergo a nucleic acid test (NAT) for HCV RNA to detect the presence of HCV in order to confirm chronic HCV infection. Chronic HCV infection can cause liver cirrhosis, hepatocellular carcinoma (HCC) and liver failure all of which are progressively fatal if affected people do not receive appropriate treatment.

HCV TREATMENT IS WITHIN REACH Fortunately, there now are highly effective, safe, well-tolerated and pan-genotypic treatments in the form of Direct-Acting Antivirals (DAAs) like sofosbuvir, ledipasvir and daclatasvir available in India which can cure most PLHCV. Results from clinical trials of daclatasvir and sofosbuvir demonstrate cure rates of up to 98% in Genotype 1 and 89% in Genotype 3, the two most common genotypes found in India, after 12 weeks of treatment. 5 This is a significant improvement from interferon-based therapies, which offer only 45-70% cure rates 6 besides having worse toxicity and side effects compared to DAAs. Sofosbuvir, a DAA with pan-genotypic properties, is now the backbone of HCV treatment across the world. In India, it is now available at less than half the price of interferon-based therapies. Sofosbuvir fixed-dose combination with Ledipasvir is also available in the market, as is Daclatasvir, another pangenotypic drug, the latest DAA to be approved in India. Sofosbuvir based regimens are likely to cure most PLHCV including the difficult to treat genotypes. With generic versions of these key DAAs being available in the market and the resultant competition, it is very likely that the prices of these medicines will decrease further in the medium to long term, presenting an opportunity to scale-up treatment services for PLHCV.

While Gilead has priced sofosbuvir exorbitantly in developed country markets, for example, in the United States, a three month course of treatment is priced at USD 84,000 (54,60,000 INR), generic versions are available in India at USD 306 i.e. INR 19,900 (approximately) making Indian prices 99% cheaper than the US price for sofosbuvir which is USD 84,000.7 Generic Sofosbuvir and Ledipasvir FDC is priced at around Rs. 25,000 for a month’s treatment while Daclatasvir is available at Rs. 46000 (approximately). Given that India is a leader in production and supply of generic medicines globally and that with more generic entrants into the market the prices are likely to reduce further, Indian generics could be well-placed to supply new DAAs to the developing and developed world at affordable prices. But voluntary licenses that Indian generics have signed with Gilead risk restrict licensees global sales to mostly low-income, low burden countries which might impact decisions of generic companies to supply to many of these countries. In addition, the high cost of diagnostics pose an additional barrier to initiating and scaling-up treatment services.

Soul of Healing with its subsidiary Sunny Pharma based in Bangalore provides for through its PAP generic medication that can treat Hep C. For more information please feel free to visit and contact us.