Another Pill for Sex - this one blocks HIV
According to AP, the first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.
In a series of votes, a Food and Drug Administration advisory panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-positive partner.
The FDA is not required to follow the panel's advice, though it usually does. A final decision is expected by June 15.
Gilead Sciences Inc., based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe it as part of a drug cocktail to repress the virus.
While panelists ultimately backed Truvada for prevention, Thursday's 12-hour meeting highlighted a number of concerns created by the first drug to prevent HIV. In particular, the panel debated whether Truvada might lead to reduced use of condoms, the most reliable defense against HIV. The experts also questioned the drug's effectiveness in women, who have shown much lower rates of protection in studies.
Panelists struggled to outline steps that would ensure patients take the pill every day. In clinical trials, patients who didn't take their medication diligently were not protected, and patients in the real world are even more likely to forget than those in studies.
Panelists stressed that people should be tested to make sure they don't have HIV before starting therapy with Truvada. Patients who already have the virus and begin taking Truvada could develop a resistance to the drug, making their disease even more difficult to treat.
Truvada first made headlines in 2010, when government researchers showed it could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.
According to RED more than 33 million people in the world have HIV; over 22 million live in Africa. Zambia has the highest percentage of HIV prevalence at 13.5% with a population of 13.5 million. However, South Africa, with a greater population, has the highest number of people living with HIV, estimated at 5, 600 000.
Truvada could be a breakthrough prophylactic medicine which could dramatically decrease the spread of AIDS infection. Although it is not a cure for AIDS once the patient has it, it has been proven to prevent infection by 75% - making it safer for couples with one HIV positive partner.
Unfortunately, Africa cannot as of yet be too excited about the endorsement of this drug as various studies in Africa done last year have found it to be ineffective, especially among women. The cause of this is not clear, although it appears that some women may not be taking the correct dosage. The drug only works properly if taken daily, 100% correctly.
In another story, according to the NY Times, a small British trial of an injectable, once-a-month formulation of rilpivirine, a possible new anti-AIDS drug, showed that it appeared safe and lingered long enough in the body to prevent infection. This means it could act like Truvada, for prevention for people without AIDS, but without the need to remember a daily pill.