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Publications 2003

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2003 Antiretrovirals Pipeline Report
The pipeline is bursting, with at least the following compounds twinkling in the eyes of scientists around the globe. It is by no means a full list, but those substances in red were presented at the recent CROI in Boston. There seems to be no lack of investigation — bench scientists are having a field day!

Position Paper on FTC (emtricitabine) brand name Emtriva
2003 - FTC is a once-daily (QD) thiacytidine nucleoside analogue developed by Triangle Pharmaceuticals, North Carolina. Triangle is now owned by Gilead Sciences. The compound was licensed from Emory University in 1996. It comes in 200 mg capsules and should be stored at room temperature, between 15-30 C (59-86 F). There are no food restrictions with FTC administration.

Postition Paper on Fosamprenavir Approval
October 2003 - Based on data from ongoing and completed studies, and to the extent the sponsors have provided requested information, TAG and the undersigned organizations and patient advocates of the community of people living with HIV/AIDS support the full approval of the GSK/Vertex application to FDA of Lexiva® brand 908 (fosamprenavir, NDA 21-XXX) to treat HIV infection in combination with other antiretroviral
agents in adults. However, we support the approval of 908 only in combination with low-dose ritonavir (908/r).

Postition Paper on FDA Approval of Atazanavir (Reyataz)
June 2003 - Atazanavir (ATV) is an azapeptide protease inhibitor under development by Bristol- Myers Squibb for people with HIV starting their first treatment regimen with a PI. Based on data from ongoing and completed studies, TAG and the undersigned organizations believe that the FDA should approve the Bristol-Myers Squibb application for accelerated approval of Reyataz® brand atazanavir (NDA 21-567 and 21-568) to treat HIV infection in combination with other antiretroviral agents in adults, provided that the follow up studies recommended below are commenced and successfully completed in a timely fashion.

Brand New, You're Retro
TAG Basic Science Project 2003 Retrovirus Conference Report
May 2003 - One major theme that emerged at this year's Retrovirus conference was a renaissance of interest in neutralizing antibodies. Antibodies are small Y-shaped molecules produced by B-cells that can lock onto foreign particles (such as viruses) floating in the bloodstream, thus preventing their replication and marking them for elimination from the body. HIV is notorious for evading antibody responses, seemingly due to its heavily sugared and mutable outer envelope which serves to shield regions of the virus that might otherwise be susceptible to an antibody attack.

Fuzeon Brand Enfuvirtide (T-20): Breaking Barriers or Breaking the Bank?
March 7, 2003 - Research and advocacy have brought forth 16 approved antiviral medications targeting two different stages in the HIV lifecycle. These drugs, when used in potent combinations, have significantly reduced morbidity and mortality in people living with HIV. However, for the large number of people who have been treated for years and have developed drug-resistant viral strains, the present drugs are often insufficient to achieve durable viral control. Because HIV rapidly evolves resistance and cross-resistance to available drugs, there is a clear need for therapies that target other points in the HIV lifecycle.

Critical Issues From TAG's Forthcoming HCV/HIV Coinfection Report, Version 2.0
Research and Policy Recommendations for HCV/HIV Coinfection
February 2003 - The unfolding epidemic of hepatitis C virus (HCV) infection is a serious and growing problem. An estimated 170 million people around the world are infected. In the United States, at least four million people have been exposed to HCV, and 2.7 million of them have developed chronic hepatitis C. Chronically infected persons can either remain asymptomatic, progress very slowly, maintain mild to moderate liver scarring or develop serious liver damage, such as cirrhosis or hepatocellular carcinoma (HCC). Hepatitis C-related liver damage has become the chief cause for liver transplantation in this country, and ten to twelve thousand people die each year from HCV-associated end-stage liver disease (ESLD). HCV disease is a particularly severe problem for HIV-positive people. Up to a quarter of all people with HIV in the U.S. may be coinfected with HCV. The progression of hepatitis C is accelerated in HIV-positive individuals, and HCV-related ESLD has become a leading cause of death in those with HIV.

Basic Science Review
January/February 2003

Swiss-Spanish Intermittent Treatment Trial Downer
January 29, 2003 - October 2002 saw the first publication of results from the Swiss-Spanish Intermittent Treatment Trial (SSITT), the largest study of structured treatment interruptions (STIs) in chronic HIV infection conducted to date. The design of SSITT was based on the "autovaccination hypothesis" -- the idea that short interruptions of HAART might augment the immune response to HIV by exposing the immune system to brief, time-limited bursts of viral replication. Evidence supporting this hypothesis has been reported from studies in acute HIV infection, but results so far in chronic infection have been mixed, at best, and highly controversial.