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Publications 1999

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tagline 1999

Policy Statement on Application for Approval of Adefovir for HIV
1 November 1999 - On June 29th, 1999, Gilead Sciences, Inc. submitted new drug application (NDA) 20-993 to the US Food and Drug Administration (FDA) for accelerated approval of Preveon™ brand adefovir dipivoxil (formerly known as bis-pom PMEA). Adefovir is a nucleotide analog that inhibits the reverse transcriptase (RT) enzyme of the human immunodeficiency virus (HIV). Unlike the nucleoside analog reverse transcriptase inhibitors (RTIs), such as AZT, ddI, d4T and 3TC, adefovir, which possesses a phosphate group, requires only two intracellular metabolic steps to be converted into its active form. While intriguing data have been presented regarding the activity of adefovir dipivoxil against HIV that has developed resistance mutations to lamivudine (3TC), the overwhelming preponderance of studies of the drug's activity have been disappointing, and the rate of serious renal toxicity in patients treated with adefovir is high. Consequently, the application for approval of the drug presents regulators and patient advocates with particular challenges.

Structured Treatment Interruptions Workshop Summary
August 1999 - From 30 July to 1 August 1999, a diverse, internation al group of biomedical researchers, statisticians, clinicians, research administrators and community treatment advocates met to discuss and develop plans for research on structured treatment interruptions (STIs) in the context of highly active antiretroviral therapy (HAART). Participants reviewed observations to date, currently available virologic, immunologic and clinical hypotheses, and reviewed studies now underway or in the planning stages. They evaluated STI research in the context of fully-virally suppressed patients with primary or chronic HIV infection, and multi-drug resistant (MDR) patients who are failing to achieve full viral suppression. In a series of intradisciplinary and in terdisciplinary breakout-groups, participants identified gaps in current STI research and developed several proposals and mechanisms to address these gaps, and to coordinate and expedite the overall STI research effort.

Policy Report on Application for Ageneras Approval
February 19, 1999 - If one should hear yawns emanating from the consecrated halls of the Food and Drug Administration (FDA), it's possible that the team evaluating the New Drug Application (NDA) for Agenerase™ brand amprenavir is responsible. The HIV treatment community seems equally detached as it looks ahead to the seemingly more potent ABT-378 and a couple of early stage compounds with wished-for efficacy against protease mutated virus. Regardless, amprenavir is likely to become the youngest member of the protease party of five since preliminary data suggests that its strength and safety are comparable to its approved forerunners. Though ordinary in many ways, amprenavir offers the expedience of twice per day dosing without dietary restriction.