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Publications 2004

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ICAAC Roundup, 2004
The Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) is the annual meeting of the American Society for Microbiology. In 2004, it happened in Washington DC from 30 Oct to 2 Nov. Some new drugs were presented along with data on new strategy initiatives. Here, a quick roundup.

Report from the 3rd International TB/HIV Community Workshop
December 2004 - The 3rd International Community TB/HIV Workshop was held in Paris from October 26-29, 2004. Participants were nominated by organizations and networks from all regions. From 229 applicants the Advisory Committee — Beverley Figaji (Namibia), Ezio Santos Filho (Brazil), Pervaiz Tufail (Pakistan) and Wan Yanhai (China) — selected 40 persons to attend the Workshop. Additional participants came from AIDES, the Bill & Melinda Gates Foundation, the European AIDS Treatment Group (EATG)/European Community Advisory Board (ECAB), Gay Men’s Health Crisis (GMHC), Open Society Institute (OSI), the Stop TB Partnership Secretariat, TAG, UNAIDS and WHO.

TAG Testimony to the FDA Vaccines and Related Biological Products Advisory Committee
September 28, 2004 - On September 23, 2004, the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee held a hearing to discuss the ongoing "prime-boost" Phase III HIV vaccine trial in Thailand. TAG submitted the following testimony to the hearing.

Brand-name FDCs and PEPFAR, 2004
September 2004 - In January 2003, W announced PEPFAR, The President's Emergency Plan For AIDS Relief, pledging 15 billion dollars of funding over 5 years, to provide testing and treatment in 15 countries affected by HIV/AIDS. Critique of PEPFAR has highlighted several things, including the narrow focus on 15 countries, and the requirement that PEPFAR funds only use brand-name ARVs in the treatment programs initiated in these countries. Since brand name drugs are prohibitively expensive—even after countries negotiate with the companies for discounts—and PEPFAR treatment funds are relatively low, excluding generics from the PEPFAR treatment plan means that far fewer people will have access to life-saving treatment than is possible with the use of generics.

Epzicom Brand Abacavir-Lamivudine QD
The Difference Between Drugs and New Drugs

August 2004 - FDA announced approvals in early August of two fixed-dose combination (FDC) antiretroviral drug products for use with other antiretroviral agents for the treatment of HIV-1 infection. FDCs are combinations of two previously approved drugs in what is understood to be an easier form, in both cases one pill a day, like Comibivir® already on the market, a combination of retrovir (AZT) and lamivudine (3TC). This paper will address what is known about Epzicom. While this new approval is a new and interesting option, it consists of previously approved, possibly previously taken and failed drugs, and is not, in and of itself, useful for everyone.

Two Out of Three Ain't Bad
Truvada Enters the Market at Full Blast
August 2004 - Truvada® is a single pill containing 300mg of tenofovir disoproxil fumarate (Viread, TDF) and 200mg of emtricitabine (Emtriva, FTC). These two drugs were previously approved individually under the brand names of Viread® in 2001, and Emtriva® in 2003.

Hepatitis C Virus (HCV) and HIV/HCV Coinfection: A Critical Review of Research and Treatment
July 2004 - TAG’s Hepatitis C and HIV/HCV Coinfection Report is a comprehensive review of basic and clinical science accompanied by recommendations for research and policy. It was written for people living with hepatitis C or HIV/HCV coinfection, clinicians, researchers, activists, educators, and advocates.

Chronic shortage of donor organs threatens people with HIV, 2004
Regardless of HIV status, transplant candidates face a daunting shortage of livers

TAG's HCV/HIV Coinfection Project Director, Tracy Swan, explores the impact of the chronic organ shortage on HIV-positive people who have developed end-stage liver disease (ESLD) from coinfection with viral hepatitis (and other causes), and ideas to increase the supply of donor organs.

Pharmacokinetic (PK) Issues and Drug-Drug Interaction Studies, 2004
This letter will focus on pharmacokinetic (PK) issues as they apply to specific populations and drug-drug interaction studies (1), to wit, on outlining possible changes regarding required or desirable pharmacokinetic and drug-drug interaction data. This data should be available from sponsors of investigational new drugs (INDs) for treatment of HIV disease and associated complications, either at the time the new drug application (NDA) is submitted, or as part of the suite of required post-marketing studies.

NIH Hearing on Norvir 400% Price Increase, 2004
On Tuesday, May 25, 2004, the National Institutes of Health (NIH) hosted a public meeting to seek comment from invited individuals, organizations, and other stakeholders on the use of the government march-in authorities under 35 U.S.C. 203 for Norvir© (ritonavir). Norvir© is a drug manufactured by Abbott Laboratories that was developed with NIH funds using inventive technologies. The "march-in authorities" refer to a clause of a piece of legislation (the Bayh-Dole Act) passed in 1980. This Act—spearheaded by Senators Birch Bayh of Indiana and Bob Dole of Kansas—aimed to stimulate research and product development of new drug agents funded by the US Government.

2004 Antiretrovirals Pipeline Report
February 2004 - Pipelines are almost as delicate and fragile as the ecosystems they go trampling through. Oft times the way to get from the beginning to the end is not a straight line. Although that does remain the quickest way geometrically, there may be other factors at play. For oil to get to the Black Sea, sometimes the pipeline has to go around countries and political factions, rather than through them. And on the way, discoveries are made and decisions are taken.