What is Hepatitis C?
71 million people worldwide chronically infected in 2015
81% 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. However, research and development (R&D) for the DAAs has been focused on one genotype 1, predominant in high-income countries, neglecting the huge number of patients worldwide infected by other genotypes that are predominant in low- and middle-income countries. The prohibitively high cost of drugs means that access is a problem in low- and middle-income countries.
There is a need for:
- A vastly improved therapy effective against all genotypes that is efficacious, well-tolerated with a short treatment duration, and simple to use (once-daily oral with low pill burden, less need for on-treatment monitoring) would be ideal. Hopefully more patients, particularly those with advanced liver disease, or co-infection with HIV or hepatitis B (HBV), will benefit from further development and optimization of pipeline DAAs.
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.
An alternative Research and Development Strategy to Deliver Affordable Treatments for Hepatitis C Patients
DNDi‘s hepatitis C drug development strategy based on patient needs, not profits