What is Hepatitis C?
71 million people worldwide chronically infected in 2015
72% of patients live in low- and middle-income countries
2.3 million people suffer from HIV/HCV co-infection
Approximately 400,000 deaths per year from HCV-related liver diseases
15–30% of those chronically infected develop cirrhosis of the liver within 20 years
Although HCV is found throughout the world and there are six different major genotypes (GTs) of the HCV virus which are distributed across different regions, GT1 is most prevalent in high-income countries and GT3 is the most prevalent in low- and middle-income countries and accounts for 30% of global HCV infection.
HCV is a blood-borne virus and hence the most common modes of infection are through unsafe injection practices, inadequate sterilization of medical equipment in some healthcare contexts, and un-screened blood/products. HCV can also be transmitted sexually and can be passed from an infected mother to her baby, but this is less common.
Following infection, there is an incubation period of two weeks to six months. After this period, approximately 80% of people are asymptomatic. The acutely infected may suffer from fever, fatigue, decreased appetite, nausea, vomiting, abdominal pain, dark urine, grey-coloured faeces, joint pain, and jaundice (yellowing of the skin and the whites of the eyes).
Patient treatment needs
The goal in treating HCV infection is to reduce virus-related complications. This is achieved by eradicating the virus as documented by a sustained viral response (SVR) several months after therapy discontinuation.
Treatment for HCV has evolved over the past decades from the use of interferon monotherapy in the 1980s to the use of pegylated interferon. This drug must be administered through injections, with side effects that are difficult to tolerate, and is only successful 40-80% of the time and must be provided for at least 24 weeks and often up to a year. Also, it is often combined with another poorly tolerated drug, ribavirin.
More recently-approved Direct Acting Antivirals (DAAs) have revolutionized the HCV therapeutic landscape. The new DAAs are all oral, with a sustained virologic response (cure) rate upwards of 95% and are usually taken daily for only 12 weeks. As of early 2018, there were at least 11 different DAA regimens that have been approved by at least one stringent regulatory authority since 2013. Only three of these were approved as pan-genotypic regimens, and each of the three had limitations in terms of access in low- and middle-income countries.
DNDi aims to deliver:
- A safe, effective, and easy-to-use direct-acting antiviral regimen, to be used as an affordable combination paving the way for a public health approach to HCV.