Gilead Drugs to Prevent HIV Spurned by African Women in Study

Drugs made by Gilead Sciences Inc. (GILD) that can prevent healthy adults from getting HIV didnt reduce infections in African women because of lack of adherence to treatment, raising questions about the medicines usefulness in stopping the spread of AIDS.

About two thirds of women didnt consistently use Gileads daily pill Truvada or Viread, which came in the form of a pill or vaginal gel, according to the study released today at the Conference on Retroviruses and Opportunistic Infections in Atlanta. The women in the study said they were deterred from using the medicines because of stigma associated with AIDS drugs and side effects, which can include diarrhea and nightmares.

Women were not using the product and those women least likely to use the product are the ones most at risk for HIV infection, they are young women and those who are not married, said Jeanne Marrazzo, a researcher at University of Washington in Seattle who led the study.

The finding may cause global health officials to rethink their strategies for using the treatments as a form of prevention. U.S. regulators approved Gileads Truvada last year as the first drug to prevent HIV infection in healthy adults. Health organizations worldwide have been studying ways to get the pill to regions hardest hit by the epidemic and have called it a new tool in ending the epidemic.

In addition to being used as a form of pre-exposure prophylaxis, know as PrEP in the AIDS community, Truvada is a main treatment for people infected with AIDS and works by stopping the virus from taking hold and replicating in the body. It had more than $3 billion in sales last year.

Because of the irregular use, there was no significant difference in AIDS infection rates in the women taking the drugs compared to a placebo.

Some of the 5,000 women in the study, many who enrolled for the free health services, said they werent using the products because of the stigma associated with taking an AIDS medication, even with the knowledge that it was to prevent the disease, Marrazzo said. Others had issues with the side effects though those typically clear up over time, she said.

The findings reinforce what we already know from previous trials -- these interventions work when they are used, and they dont work when they are not used, said Mitchell Warren, executive director of AVAC , a New York-based AIDS advocacy group. Now we have a dual responsibility to understand who might benefit from daily PrEP and ensure that they can access it, and to accelerate the development of additional options that can meet the urgent needs of others.

In the study, women received either Gileads Viread as a pill or vaginal gel, the daily pill Truvada, which combines Viread with Gileads emtricitabine, or a placebo pill or gel. Most of the women were in South Africa with the remainder in Uganda and Zimbabwe.

About 6 percent of patients assigned to the Viread daily pill or vaginal gel group developed HIV and 4.7 percent in the Truvada group become infected. That compares to 6.8 percent who became infected using a placebo gel and 4.2 percent infection rate among the placebo pill group.

Read the original here:
Gilead Drugs to Prevent HIV Spurned by African Women in Study