Med Monitor

The Food and Drug Administration has approved Aptivus, a nonpeptidic protease inhibitor from Boehringer-Ingelheim. The drug was shown to be effective against PI-resistant strains of HIV. Aptivus, now available nationwide, should be taken with a booster dose of Norvir. __________ Drugmaker Roche has advised health care professionals that it will stop sales and distribution of Fortovase, one of its protease inhibitors, by February 15 because of low demand. Roche's Invirase'which, like Fortovase, is a formulation of saquinavir'will continue to be available. __________ A pilot study in the July 1 edition of the Journal of Acquired Immune Deficiency Syndromes has shown that a nucleoside-sparing regimen containing just Kaletra and Sustiva is as effective as most three-drug regimens in reducing blood-based HIV viral loads and boosting CD4-cell counts. __________ HIV patients failing to achieve adequate blood-based concentrations when taking standard doses of the protease inhibitor Kaletra rarely achieve therapeutic levels by boosting their Kaletra dosage, according to a study in the July 1 edition of the journal AIDS. Drug side effects also were more likely with dosage increases. __________ A skin-patch test that screens for high levels of CD8 cells is effective in diagnosing risk factors for serious and possibly life-threatening hypersensitivity reactions to the nucleoside analog Ziagen. Researchers suggest combining the skin-patch test with immunological and genetic screenings to help diagnose and prevent Abacavir Hypersensitivity Syndrome. __________ Pfizer has announced it is abandoning development of experimental nonnucleoside analog capravirine because tests showed it was not more effective than existing antiretroviral drugs. __________ Tibotec is launching an expanded access program for the experimental protease inhibitor TMC114. Tests have shown that TMC114 is active against protease-resistant strains of HIV. Tibotec says that in 2006 it will seek accelerated approval for the drug. __________ Gilead Sciences has launched a Phase I/II study of its experimental integrase inhibitor GS 9137, which aims to prevent HIV from integrating viral genetic material into cellular DNA, a step necessary for the virus to replicate. The drug was previously evaluated in a Phase I trial in Japan. __________ A study in the July edition of The Annals of Pharmacotherapy has shown that once-daily administration of Ziagen is as effective in suppressing HIV replication as a twice-daily dosing, but the dose was linked with increased risk for hypersensitivity reactions and severe diarrhea. __________ Bristol-Myers Squibb has cut the price in poor nations of pediatric formulations of Zerit and Videx. Zerit's price was reduced by 44%; Videx's price was cut by 90%.