An accompanying editorial in JAMA reviews the development of drugs that are effective against drug-resistant HIV and cites the FDA decision. Its benefits must be balanced, however, with side effects that were manageable but did involve nausea and other gastro-intestinal problems as well as increasing kidney problems in about 60 percent of the patients over time. Among other positive results, the drug showed that it remained active when integrated with other antiretroviral drugs in a treatment regimen known as combination therapy. Combination therapy is designed to maximum the medication potency against HIV by striking at a variety of different biochemical mechanisms and at several vulnerable points in the viral lifecycle. Over the past four years, antiretroviral therapy has led to improved survival for many HIV patients, however, because of the development of resistance, there is an ongoing effort to develop new anti-HIV medications that will add to the drug arsenal for combination therapy, Kahn said.
Every patient is different, so there is no universal combination drug therapy.
The combination needs to be adjusted and individually tailored for each patient for optimum benefit. All study participants were treated for at least eight weeks with antiretroviral combination therapy immediately preceding the beginning of the trial. Half the patients received the drug and half received a placebo, an inert substance with no medical benefit. All were encouraged to continue with their antiretroviral regimens. The drug was administered as a pill, taken orally once a day for 24 weeks.