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I am excited about HCV protease inhibitors which are orally active drugs with great strength. VX-950 from Vertex Pharmaceuticals has been named telaprevir, and it drops the viral level by about 99.9% in a week or two. The viral level then is about the same, and resistance comes into play. It has to be taken by mouth every 8 hours without fail, which makes patient compliance a problem. When telaprevir is combined with Pegasys plus ribavirin, it dropped the HCV-RNA to undetectable in 12 of 12 genotype one patients in 28 days. Phase 2 studies are underway and a big phase 3 study will start in 2008. I expect it will be a big help in previously untreated genotype one patients, and could double success. The standard treatment may fall from one year to only 6 months for genotype one patients. I hope it is tested alone without interferon or ribavirin in patients with sarcoidosis, liver failure, ITP and others who cannot take interferon. It is possible that reducing the HCV-RNA by 3 or 4 logs will reduce liver damage even without cure, but that must be proven. Oral drugs for HCV are being developed by pharmaceutical companies. The hope is that oral drugs will control HCV without using interferon. They would be taken by mouth and will be similar to the drugs taken for HIV or HBV. Those proven safe and effective would allow us to avoid the side effects and risks of interferon based therapy. I do not think that these new drugs will cure HCV if not combined with interferon, but I expect they will control it. When combined with interferon plus ribavirin they will shorten treatment duration and will increase the number cured. HCV protease inhibitors and other oral drugs will be the third major advance in treating HCV. First was interferon approved in 1992, second was ribavirin approved in 1998 and HCV protease inhibitors is number 3. Pegylated interferons were approved in 2001-2 and are convenient, but are not as big of a help as ribavirin. With strong protease inhibitors, we will cure many more patients. If you are interested in participating in a clinical trial to
test new drugs go to
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