The Food and Drug administration approved a drug, Truvada, to reduce the chances of HIV infection. This just after the first HIV home test was approved by the FDA. HIV infections in the United States hold steady at about 50,000 new cases per year. Currently there are 1.2 million Americans with HIV, which develops into AIDS unless treated. It is hoped this drug will reduce the number of new cases.
The use of Truvada is called preexposure prophylaxis, and is used to prevent HIV infection from partners of HIV infected individuals. Preexposure prophylaxis had been limited to the use of condoms. It is hoped that intervention with Truvada, and possibly other drugs, will provides major step toward reducing HIV infections in the United States. The drug is effective to reduce transmission by as much as 75% in heterosexual and gay couples. Another study whosed that daily doses cut the risk of infection in healthy gay and bisexual men by 42% when used with condoms and counseling. In another study Truvada reduced the infection rate in heterosexual couples when one partner was infected.
The drug is Truvada, a combination of two anti-viral drugs tenofovir and emtricitabine. Truvada has been used, in combination with other drugs, for patients who have HIV but is not effective used alone.
The results from the study varied widely, from 40% to 75%, and while some could be explained by adherence to the daily regimen of the drug, there were clearly roles for other factors. The drug must be taken daily, and cannot be skipped, and the partners must use condoms with sexual activity. During one of the studies there was a high rate of pregnancy, indicating that unprotected intercourse was more common than self-reported.
Before prescribing the drug, the patient must be confirmed to be HIV negative. This was not made a requirement by the FDA. A patient who has HIV and uses this drug has ineffective treatment for HIV, which requires three anti-viral medications, and the concern would be that if an HIV positive patient uses this drug they may develop a resistance to this medication.
The drug is not risk free and there was noted changes in kidney and liver function as well as reduced bone density. Side effects include diarrhea, nausea, abdominal pain, headache, and weight loss. The FDA will continue to monitor the drug for adverse events. The other concern is that Truvada will lead to unprotected sex. In addition, there is no data regarding the use of Truvada in pregnancy
The drug is costs about $13,000 per year, and there is no word if insurance will cover the use of the drug.
We still await, however, a vaccine against HIV.
