The ACTIVATE Study: Enhancing Hepatitis C Treatment for People Actively Using Injecting Drugs
In Australia, hepatitis C is a major health problem among people who use drugs. Among every 100 people who have ever injected drugs in their lives, 70 people will have been exposed to hep C virus and 50 people will develop ongoing hep C infection. After 20-30 years of having hep C, people may develop serious long-term problems including scarring of the liver (cirrhosis), liver cancer and death due to liver disease. This is a big problem among people over 40 years of age. It means that one out of every two people who have ever injected drugs may have problems because of hep C, especially people infected with hep C in the 1970s, 1980s or 1990s.
The good news is that there is a cure for hep C! The treatment has two parts. The first part is called pegylated interferon and you take this once a week as an injection. Interferon is actually a protein that your body produces naturally to fight off infections. When you have the flu virus, the reason you feel bad is not because of the virus itself, but actually because of the natural interferon that your body makes. Unfortunately, this also means that when you take the interferon, you also sometimes feel like you have the flu! The second part to hep C treatment is called ribavirin. You take this as pills twice a day. The combination of pegylated interferon and ribavirin is used together to cure hep C.
There are three main types of hep C virus in Australia. These different types are called “genotypes”. The main types are genotype 1, genotype 2 and genotype 3. Understanding your genotype is very important because some types of hep C are easier to treat than others. The most difficult to treat is genotype 1, while genotypes 2 and 3 are easier to treat. This means that standard treatment for genotypes 2 and 3 is shorter (only 6 months as compared to 12 months for genotype 1). Also, four out of every five people with genotypes 2/3 will have a cure following 6 months of treatment! In people with hep C genotype 1, half of them will have a cure with 12 months of treatment.
Among people who inject drugs, it is very important to treat hep C. A number of studies have shown that people who use drugs can respond very well to treatment. Also, guidelines throughout the world suggest that people who use drugs should be treated for hep C.
Fortunately, there is a study that will be starting in March 2012 called the ACTIVATE study. This is a study which will examine whether shortening treatment for hep C is feasible, safe and effective for people who are currently injecting drugs and who are responding well to treatment early on. The purpose is to investigate whether hep C treatment can be shortened from the standard 24 weeks (standard duration) to 12 weeks (shortened duration) if a patient has a rapid response to the treatment. A rapid response is where there is no hep C virus detectable in the blood after four weeks of treatment. The study will examine this in people who are infected with hep C genotype 2 or 3 and have injected drugs recently (injecting drug use in the previous 12 weeks).
The study is part of an international collaborative study sponsored by the University of New South Wales in Sydney, Australia and is being funded by Merck Sharpe and Dohme. The study will involve a total of 100 patients from Australia, Canada, Belgium, France, Norway, Switzerland, United Kingdom, Germany and Finland. In Australia, the clinics involved will be in Sydney (St. Vincent’s and Nepean Hospitals), Newcastle (Hunter Pharmacotherapy), Melbourne (the Alfred Hospital) and Adelaide (the Royal Adelaide Hospital).
Jason Grebely and Gregory Dore