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by Alan Franciscus
2005 was an incredible year for important news on advances in knowledge about hepatitis C. Below is a list of what we believe are the top stories about hepatitis C for 2005. It is difficult to assign a number to each and every one of the news stories below, but without a doubt the most important news stories of 2005 were the discovery of a saliva-based HCV test, replication of HCV in a test tube, followed by news about how HCV infects a cell and how HCV evades the immune system. There were also many important news stories about clinical trials on new drugs to treat hepatitis C.
The other stories are listed alphabetically and not in any particular order of importance. There may be other news stories that our readers feel should have been included in our Top Eleven list. If so, please drop us a line and let us know if we missed any important news.
1. Saliva-Based Test Developed for Hepatitis C.
On December 23, 2005 it was reported that scientists from Israel have developed a saliva-based test for detecting HCV antibodies. The scientists found that the results obtained from their salvia test were as good or even better than the test using serum or blood samples to detect HCV antibodies. Larger tests are needed to confirm these findings. This could be a milestone for HCV testing since a salvia test is less expensive, less labor intensive and easier to perform, thereby making mass screenings a reality.
2. HCV Replicated in a Test Tube
The growth of our understanding of hepatitis C was particularly important this year – more so than in any other year since the discovery or identification of HCV.
For the first time, scientists at the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) were able to replicate the hepatitis C virus (genotype 1) in a test tube. This system only represents the end of the viral life cycle, but a very important advance. Another HCV model system is needed to show the beginning stages of the viral life cycle.
Another group – The Rockefeller University – has produced an infectious form of HCV in a laboratory culture of human cells. In addition, the Rockefeller group was also able to identify a potential molecule that plays an important role in the entry of HCV into the host cell.
Other important breakthroughs are from researchers at UC Berkeley, New York University School of Medicine, University of Texas and The Johns Hopkins University School of Medicine who identified various mechanisms of action with regard to how HCV invades a human cell and how it evades the immune system.
These discoveries are very important because greater understanding of how HCV works and the ability to culture HCV in a test tube will provide important insights that will lead to the development of new drugs to treat as well as to eradicate HCV.
3. Hepatitis C Epidemic Control and Prevention Act
S521 and HR1290 was reintroduced in January 2005. This bill will provide monies to promote hepatitis C testing, counseling and referral to care in state, local and tribal programs. In order for this bill to pass and become law, a strong grass roots advocacy is needed. Have you contacted your local, state and national representatives to make your voice heard on this important legislation?
On a related note, the Decca high school kids have embraced the cause of hepatitis C and are actively educating the public and walking the halls of congress to drum up support for the legislation. In December 500 students from the DECA club at Robinson Secondary School, Fairfax, Virginia held a rally and press conference on the steps of the Capitol building, which I attended. It was heartwarming to see so many kids take up the cause of hepatitis C – the staff of HCSP are very grateful and appreciative of their efforts.
4. HIV/HCV Coinfection Treatment Guidelines
The U.S. Veterans Administration and The European Consensus Conference issued guidelines for the management and treatment of people infected with HIV and hepatitis C. This is important since hepatitis C in the setting of HIV accelerates hepatitis C disease progression and HIV medications can potentially cause liver damage. Up until now there have been no influential groups issuing management and treatment guidelines to help medical providers and their patients manage HIV and hepatitis C coinfection. The European Consensus Conference panel also included recommendations for the management of HIV/HBV coinfection.
5. Needle Exchange
Sadly, needle exchange in the U.S. lags behind most other democratic countries. However, there were some advances and victories in 2005. There also seems to be a change of mentality in some parts of the country: more people are beginning to see needle exchange in terms of disease prevention intervention as opposed to viewing it as a practice that encourages drug use. This is a hotly debated topic that will surely continue to be in the news for many years to come.
6. Pegasys plus Copegus FDA Approved for HCV Treatment in HIV/HCV Coinfected Patients
Early this year, the combination of Pegasys plus Copegus (ribavirin) was approved by the FDA to treat hepatitis C in people with HIV/HCV coinfection. This is the first (and only) HCV medication approved by the FDA to treat the estimated 300,000 individuals in the U.S. infected with both HIV and hepatitis C. This is an important milestone in treatment because people infected with both viruses are at greater risk for HCV disease progression. Another first for Pegasys is the FDA approval of Pegasys monotherapy as the only pegylated interferon for the treatment of chronic hepatitis B which affects approximately 1.25 million Americans.
Other noteworthy news about Roche was their national campaign on hepatitis C. Almost every large city in the country ran ads in newspapers, billboards, buses and kiosks about hepatitis C, and some of the ads even appeared in national publications.
7. Revised Estimate on HCV Infection in U.S.
New information revising the prevalence of HCV in U.S. upwards did not garner that much attention in the media. This is probably due to the fact that most experts know that the estimate derived from the NHANES III study was vastly underestimated because many HCV infected high risk groups or populations were not included in the NHANES III household base study. Brian Edlin and colleagues mathematically analyzed data on populations (prisoners, homeless persons, hospitalized persons, active duty personnel and nursing home residents) who are at a high risk for acquiring HCV. Had these numbers been included in the NHANES III the estimate would have increased to approximately 5 million people in the U.S. who have at one time been infected with HCV –of whom 3.9 million are currently chronically infected. It will be interesting to see if the CDC and NIH embrace these new estimates.
8. Schering’s Protease Inhibitor
Another HCV protease inhibitor came upon the scene in a rapidly expanding field of potential new HCV therapies. Phase I Data on Schering’s oral HCV protease inhibitor, SCH503034, was released at this year’s AASLD and the information looks impressive, showing dramatic viral load reductions in HCV positive patients who were treated with SCH503034 alone or in combination with Peg-Intron. Larger phase II studies are underway.
9. Valeant’s Viramadine
A prodrug of ribavirin, viramidine continues to gain momentum. In 2005 data was released showing that the overall effectiveness of viramidine in combination with pegylated interferon was similar to the combination of pegylated interferon and ribavirin, but viramidine had a lower rate of hemolytic anemia compared to the group that took ribavirin. Larger studies are underway.
Of interest, it was announced in December that Valeant had acquired the rights from InterMune to market Consensus interferon (Infergen). It will be interesting to see what Valeant does with the marketing strategy that InterMune has employed and if Valeant has a marketing strategy to leverage Infergen with viramidine.
Idenix’s Valopicitabine (NM283) is an oral HCV RNA polymerase inhibitor that in phase I and phase II studies showed a rapid HCV RNA decline. Preliminary results from a study of Valopicitabine used in combination with Pegasys showed a synergetic action with dramatic HCV RNA viral decline. Clinical trials have focused on genotype 1 non-responders to a previous course of therapy and treatment naïve (never been treated) patients. Idenix will meet with the FDA in early 2006 for approval of initiation of phase III studies.
The data from VX-950, an oral HCV protease inhibitor continues to be impressive. HCV RNA (viral load) reductions in patients treated with VX-950 were dramatic. Based on data from phase I and phase II trials, the FDA has agreed to review the data on an accelerated basis. “Fast track” status is a designation given to drugs that treat serious or life-threatening conditions. However, a company spokesperson commented that Vertex does not expect to apply for FDA marketing approval until 2008.
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