In 2010, two new drugs to treat hepatitis C (HCV) were submitted to the FDA for approval as well as requests for expedited reviews. The shortened review period has been granted to both telaprevir and boceprevir because they represent a significant improvement over current standard care (interferon + ribavirin). The approvals will hopefully happen by mid-summer.
These new HCV protease inhibitors are promising because the cure rate has shifted from about 40% on standard treatment up to around 75% by adding of one of these drugs. People new to treatment and those who stopped treatment before or whose HCV wasn't cured benefited from these new regimens. What's also encouraging is that treatment can be cut from 48 weeks to 24 for most people.
Although the course of treatment has shortened and the cure rate greatly improved, the main concern with HCV treatment is being able to manage its sometimes considerable side effects. The most common mild-to-moderate side effects were rash, itchiness, fever, tiredness, headache, nausea, trouble sleeping, anemia and diarrhea. With careful planning, most people can manage them. Beyond this year's considerable advance, there are dozens of other experimental drugs in the pipeline that hopefully will do away with the need for standard therapy, which includes injecting one of the drugs.
What these new drugs mean for HIV-positive people who live with hepatitis C is not so clear. For these approvals, the studies were done in mono-infected individuals, although clinical studies have now started in co-infected people. Since nearly 1 out of 4 HIV-positive people also live with HCV, it's important to know how successful these new drugs will be for them.
It's likely that the companies will help individuals with payment for the drug through new PAPs. For current PAP and co-pay program information, go to http://fairpricingcoalition.org/projects. Call the HIV Health InfoLine for more information on HCV, or go to HCV Advocate and HIV and Hepatitis.