Med Monitor

The Food and Drug Administration granted accelerated approval to the Tibotec Therapeutics protease inhibitor Prezista in June. When taken with a 100-milligram booster dose of Norvir, the drug is approved to treat drug-resistant virus. The FDA has required Boehringer Ingelheim to include a new black-box label warning for protease inhibitor Aptivus to warn of possible intracranial hemorrhages. The company reports that 13 patients taking Aptivus developed bleeding in the brain; eight died. The FDA has approved Gardasil, Merck's cervical cancer vaccine. It prevents infection with four strains of the sexually transmitted human papillomavirus linked to 70% of cervical cancers, which is an AIDS-defining illness in HIV-positive women. A study published in the Journal of Acquired Immune Deficiency Syndromes has shown that GlaxoSmithKline's protease inhibitor Lexiva can be safely used simultaneously with the heartburn pill Nexium. Prior studies had warned against mixing protease inhibitors with acid-lowering treatments. Independent Forensics has announced the development of the CCR5 Halotype Test, which determines human genetic resistance to HIV and helps gauge if a person will experience fast, average, or slow HIV disease progression. The test measures the number of CCR5 receptors on the surface of immune system cells; the more receptors, the faster HIV disease will progress.