AIDSWEEKLY Plus; Monday, May 11, 1998
Daniel J. DeNoon, Senior Editor
Earlier recommendations issued by a panel of experts convened by the National Institutes of Health did not include Roche's saquinavir in its initial formulation (hard-gel capsules, trade name Invirase). But recently updated recommendations include the soft-gel version of the drug, trade name Fortovase, as well as Merck's indinavir (Crixivan), Abbott's ritonavir (Norvir), and Agouron's nelfinavir (Viracept).
And the new recommendations contain even more good news for Roche.
Based on new data (see AIDS Weekly Plus, March 30, 1998), the revised treatment guidelines drop language stating that there was no demonstrated benefit of dropping viral load below 500 RNA copies/mL, the limit of currently used tests. New language notes that dropping viral load below 50 RNA copies/mL "is associated with a more complete and durable viral suppression, compared with reducing HIV RNA to levels between 50-500 copies/mL."
Roche Diagnostic Systems makes the highly sensitive Amplicor Monitor assay, which can quantitate viral loads as low as 20 HIV RNA copies/mL.
And the new recommendations continue to note that while its efficacy is unproven, one possible salvage therapy for patients failing antiretroviral treatment is the combined use of two protease inhibitors. One of the two should be saquinavir, which increases serum concentration of other protease inhibitors.
The recommendations contain another, unprecedented change: they suggest that under some circumstances clinicians might consider enrolling patients in trials of specific investigational new drugs (INDs).
These drugs include the nucleoside-based reverse transcriptase inhibitors adefovir (Preveon, Gilead) and abacavir (previously known as 1592U89, Glaxo-Wellcome) and the non-nucleoside reverse transcriptase inhibitor efavirenz (DMP- 266, trade name Sustiva, DuPont-Merck).
Another update from the NIH panel is expected before the end of 1998.
The current update is titled "Report of the NIH Panel to Define Principles of Therapy of HIV Infection and Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents." It was published in the U.S. Centers for Disease Control and Prevention (CDC) publication Morbidity and Mortality Weekly Report (MMWR) dated April 24, 1988 (Vol. 47, No. RR-5).
Companion recommendations for pediatric patients appeared a week earlier ("Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection," MMWR, April 17, 1998, Vol. 47, No. RR-4).
The pediatric guidelines advise aggressive antiretroviral therapy for all HIV infected children younger than 12 months of age "regardless of clinical, immunologic, or virologic status."
To date, the only HIV protease inhibitors available in oral solution or powder are ritonavir and nelfinavir.
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