Med Monitor

Bristol-Myers Squibb and Gilead Sciences filed for Food and Drug Administration approval in late April of their three-drug combination pill that's taken just once daily. The pill contains a full day's doses of Sustiva, Viread, and Emtriva. A decision by the FDA is expected before the end of the year. A study in the Journal of Antimicrobial Chemotherapy identifies the causes of poor interaction between Videx and Viread that leads to a drop in CD4-cell levels. Combining the drugs interferes with the intercellular activation pathways of the medications and blocks a key enzyme in the body. A 48-week study of Lexiva and Kaletra show the two protease inhibitors are comparable in their ability to reduce blood-based HIV levels. The study shows 73% of people taking Norvir-boosted Lexiva suppressed viral loads to undetectable levels, compared to 71% of those taking Kaletra, which already contains a booster dose of Norvir. Almost two thirds of highly drug-resistant HIVers who switched from multidrug therapy to taking only the protease inhibitor Kaletra were able to achieve and maintain an undetectable viral load for more than one year, according to a study presented at the 12th Annual Conference of the British HIV Association. Sustiva causes only modest changes to sleeping patterns and has no adverse effect on quality of life, according to a study in the May edition of HIV Medicine. Sleep studies showed only slight changes in sleep patterns, including a reduction in stage 2 sleep'thought to be linked with daytime alertness'and a lengthening of two dream-associated sleep stages. The study subjects did not report any changes in sleep quality or overall quality of life. Amazon Biotech filed paperwork with the FDA in April for a Phase I/II clinical trial of its experimental immune modulator AMZ 0026, which aims to prevent HIV infection from progressing to AIDS. The drug works to boost normal metabolic processes that support immune system function.