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Publications 2001

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tagline 2001

Position Paper on NDA 21-356 for Gilead Sciences' Viread™ brand Tenofovir disoproxil fumarate
3 October 2001 - In May 2001, Gilead Sciences submitted New Drug Application (NDA) 21-356 to the FDA for its VireadTM brand of tenofovir disoproxil fumarate (TDF). Gilead is seeking accelerated approval for TDF to be indicated, in combination with other antiretroviral agents, for the treatment of HIV infected adults. TDF is a nucleotide reverse transcriptase inhibitor.

Ten Texts on Saquinavir: Its Rapid Rise & Fall
June 2001 - This is a story of desperation, expediency, compromise, and misfortune – the desperation of AIDS activists in the early and mid-1990s fighting with the government, with the drug companies, and with each other over how best to move new drugs forward through the testing and approval process to save the lives of those sick with AIDS and to figure out how to extend the health of those with HIV; the expediency of drug companies trying to bring forth new anti-HIV drugs as quickly (and often, as cheaply) as possible; compromises imposed by the government agencies that were most involved, the Food & Drug Administration (FDA) and the National Institutes of Health (NIH), and by the academic scientists who worked with NIH funds and played by FDA rules; and the misfortune of thousands of people with AIDS and HIV who suffered because of inadequate drugs, inadequate studies, and inadequate information – and, ultimately, because the drug in question, Roche’s saquinavir, turned out to be a big disappointment.

Position Paper Regarding Approval of Hoffmann-La Roche's Valganciclovir for the Treatment of Cytomegalovirus (CMV) Retinitus in Patients with AIDS
On 27 February 2001, the FDA's Antiviral Drugs Advisory Committee will consider an application for approval of Hoffmann-La Roche's valganciclovir for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.

Report and Recommendations from the STI Workshop, October 2000
January 31, 2001 - The investigation of Structured Treatment Interruption (STI) has fluid borders. Interruption is considered a treatment strategy per se, an adjunct to treatment, as well as the removal of treatment. Though first proposed as an immune-based treatment strategy, STI is now being explored as a research tool for basic science and clinical investigation, an option for clinical management, a tactic for toxicity relief, a way of reducing the cost of treatment, an aid to improving patient quality of life and as a method for guiding viral evolution. Recently, research on STI has begun as a resource conservation practice for large health networks or low-resource settings such as in developing countries. In addition, many clinicians and people on therapy have simply perceived a need to study the safety of what is already an established phenomenon — the “drug holiday.” Although fears about the danger of stopping treatment have been allayed and the popularity of treatment interruption has soared, there is still no firm consensus about the safety of STI.