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Expanded Access for Nevirapine and Delavirdine

Makers of the non-nucleoside reverse transcriptase inhibitor delavirdine and nevirapine (Viramune) have filed for regulatory approval and announced temporary programs for early access to the drugs for HIV-infected individuals with CD4 cell counts < 200 (this may change). To inquire about the program for nevirapine, call Boehringer Ingelheim at (800) 595-5494; and for delavirdine, call Pharmacia Upjohn at (800) 779-0070.

OAR Loses Out on 1996 Budgetary Authority

Despite protests from prominent scientists and activists–and even President Clinton, the Republican Congress voted to hand the 1996 AIDS budget back over to the individual NIH institutes–revoking the OAR’s authority over the budget which the Congress had granted it only 3 years earlier. A massive review of the NIH’s AIDS research program is due out in April.

Lowering the Vaccine Goalpost

In an attempt to lure industry back to the HIV vaccine business, the NIAID has announced new–some say drastically watered down–criteria in oder for candidate vaccines to advance from phase one studies to larger efficacy studies. According to the new plan, vaccines that have been shown to produce neutralizing antibodies in at least 90% of the people who receive them and CTLs in at least 30% will be eligible to move onto the next phase of development. A “prime-boost” strategy currently being tested, which employs the combination of a canarypox-based vaccine followed by a boost with the Biocine gp120 product, has been shown to stimulate the production of antibodies and CTLs in 12-44% of persons vaccinated. NIAID’s Fauci added an enigmatic caveat that although the 90/30 criteria are the “minimal requirements,” they are subject to change should new scientific information surface. Unequivocally equivocal.

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