Top Eleven News Stories of 2007

[Guest guest]

Top Eleven News Stories of 2007Alan Franciscus, Editor-in-Chief

It is that time of year again when the staff of the Hepatitis C Support Project/ HCV Advocate compile a list of the most important news stories of the year. In 2007 we saw some tremendous advances in the development of new drugs to treat hepatitis C. There was also some disappointing news about the cancellation of some studies on drugs that we were all hoping would become viable treatment options in the near future. In 2006 there were tremendous strides in our understanding of the HCV lifecycle and we seemed to be on the verge of discovering exactly how the virus replicates and becoming more clued into HCV disease progression. Unfortunately, 2007 wasn’t as enlightening on these issues as 2006 – still there were some advances in research and the understanding of the hepatitis C virus. Going forward, 2008 promises to be the year that even more investigational drugs are discovered and advanced through clinical development, and there is a real possibility that science will nail down the lifecycle of the hepatitis C virus and we will finally be able to study it in depth and find out what exactly kills HCV. As well more drugs will be identified to treat hepatitis C, and improved strategies developed for managing disease progression.

Listed below is a list of news stories that our staff have identified as the most important news stories of 2007. As in years past, we have identified the number one story, but the ones that follow number one are not necessarily in any particular order.

1. Telaprevir – Two years in a row, now, telaprevir has been our top newsmaker. In 2007 phase II studies of the combination of telaprevir, pegylated interferon and ribavirin showed improved sustained virological response rates by about 10% and shortened treatment duration for people infected with HCV genotype 1 (from 48 weeks to 24 weeks). This is a major advancement. In 2008, Phase III studies of telaprevir combination therapies will commence. Another phase II study is eagerly awaited on retreatment of prior genotype 1 non-SVR responders, to see if telaprevir will improve retreatment responses in a population that has few or little treatment options.

• Albuferon – this form of time released interferon is advancing through clinical development and may offer a choice of dosing once every 2 weeks compared to weekly injections of the current pegylated interferons. It may not be a treatment advance in terms of a better treatment response rate, but it might provide less frequent injections. A phase III study was initiated and enrollment completed in 2007.

• The Future of Interferon and Ribavirin – one important piece of information that we have learned in 2007 is that interferon and ribavirin will be included in therapy to treat hepatitis C in the foreseeable future. We were all hoping that we could eliminate one or both, but the reality is that they are going to be included in the mix for quite some time until we have many more specific HCV antivirals.

• OraSure – was another top news item in 2007. There hasn’t been much news out of OraSure about the HCV rapid test, but earlier this year, OraSure stated that they hope to have their clinical trials completed by the end of 2007 and may be able to apply to the FDA for marketing approval in 2008. A rapid HCV test will hopefully get more of the estimated 70% of people who have HCV and don’t know it tested.

• Pegylated Interferon and Ribavirin Therapy – in 2006 and in 2007 we learned a lot about optimizing treatment outcome with pegylated interferon and ribavirin therapy. There have been two major strides towards improving treatment outcome: prolonging treatment duration and more effective side effect management. The big lesson we learned was that there are no ‘cookie-cutter’ treatment protocols for people with hepatitis C. Treatment needs to be individually tailored to a person based on many factors, such as age, viral load, duration of treatment, etc. Over the years, we have also come to understand treatment-related side effects and, more importantly, how to manage and relieve the side effects so that people can have improved quality of life while on therapy. Managing side effects is also important so that people can stay on treatment longer, if appropriate, and to help people take all of the prescribed medications as close to 100% of the time as possible. We have also learned that pegylated interferon and ribavirin will be the backbone of therapy for the foreseeable future; so these strides in current treatment optimization can only help us to improve future treatment outcomes.

• Nexavar – a new treatment for liver cancer was recently approved by the Food and Drug Administration (FDA) and is one of a few treatment options for people with liver cancer. It is currently the only drug approved by the FDA to treat liver cancer. In clinical trials, Nexavar was found to improve overall survival. Nexavar has already been approved for the treatment of advanced kidney cancer.

• R1626 – a promising new HCV polymerase inhibitor that is in early clinical development. R1626 produced remarkable HCV antiviral activity and does not appear to produce drug resistance – at least in the early studies. R1626 is creating a lot of excitement, but, due to some of the serious side effects, more clinical studies are being planned with different doses of R1626, pegylated interferon and ribavirin that will hopefully tease out what is the most effective dose that has the least amount of side effects.

• Insulin Resistance – information about insulin resistance and its affect on HCV treatment outcome was released in 2007 and showed that just having insulin resistance greatly reduced the chances of achieving an SVR. More importantly it was also found that lifestyle modification by way of diet, exercise and weight reduction dramatically improved the treatment response in people with insulin resistance.

• Valopicitabine – In July 2007 the FDA conducted an independent risk-benefit analysis based on the entire development program and based on their findings notified Idenix that they were putting the entire development program on hold, and it appears that Idenix will no longer develop valopicitabine for the treatment of hepatitis C. Unfortunately, there were also other drugs that didn’t live up to expectations and were taken out of clinical development; but still there are many new drugs under development that have the potential to improve treatment outcome that everyone should be optimistic about.

• Psychiatric Populations – one of the most interesting (and sorely needed) studies released in 2007 was a study on people with psychiatric disorders who were treated with interferon- based therapies. In the study, it was found that in people with psychiatric and substance use problems there was no association between treatment completion, the baseline use of antidepressants, and a history of substance use. The researchers found that people with psychiatric or substance use disorders can be considered HCV treatment candidates provided that they are given multidisciplinary support. As is always the case successful treatment outcome is dramatically influenced by support in almost every area of need. This was a much needed report on a group of people who have a very high prevalence of hepatitis C.

• Harm Reduction Efforts for Injectors – advancements have been made in the United States on various harm reduction efforts such as needle exchange, overdose prevention, and drug injector education and advocacy. There is a very interesting experiment that is currently being conducted in Vancouver, BC that people in the US should be paying close attention to. Vancouver, BC is currently running the largest needle exchange program in North America and has opened ‘safe injection sites’ where addicts can inject without fear of reprisal from law enforcement. Another benefit is that it has reduced the number of accidental overdoses because there are people in the safe sites who can treat a person who accidentally overdoses. The clear winner so far! – infection rates from HIV and hepatitis C have fallen dramatically. However, a conservative government has been sworn in and a harder line is being taken at a national level. Hopefully, we can learn from the successes and problems that the Vancouver experience is teaching us.

Listed below are some predictions that our staff has made for 2008, based on what has happened in years past.

Our staff has made the following predictions for 2008:

• Hepatitis C will finally get more national and international awareness. Planning for an expanded World Hepatitis Day is underway. Stay tuned for more information about events that will take place around the world and how everyone can get involved.

• Even more drugs will be developed to treat hepatitis C and some of the drugs in current clinical development will advance into larger clinical trials. The drugs to keep an eye on are telaprevir, boceprevir (SCH 503034), nitazoxanide, and R1626.

• We believe that in 2008 science will be able to replicate the hepatitis C virus in a test tube, which will open the door for more drug discovery and information on what kills HCV, as well as on how to prevent or slow down HCV disease progression.

• In 2008 we believe that there will be more movement towards health care reform on a local and state level as we have seen in Massachusetts and San Francisco. We all believe that the time is right for major health care reform in this country and that eventually there will be a national focus on health care reform, but it is going to take many years and much advocacy on the part of all Americans to make health care and services for all Americans a reality.

http://www.hcvadvocate.org/news/newsLetter/2008/advocate0108.html#5