How Progress Works: A Disappointing Microbicides Trial and Why We’re Not Discouraged

The FACTS 001 trial made use of applicators to dispense 1 percent tenofovir gel before and after sex. / Andrew Loxley Photography

Science is messy. Data don’t always show us what we hope they will. But science is reality, and that’s why we must be unflinching in our pursuit of getting honest feedback on what works.  Today, we got that honest feedback, and it was disappointing: What once appeared to be a major breakthrough in HIV prevention was not confirmed. Results released from a large USAID-supported trial indicate that an antiretroviral-based vaginal gel may not be effective in reducing the risk of HIV infection in women when used before and after sex.

With women increasingly vulnerable to HIV infection, we must work towards finding a prevention method to protect them.
/ USAID, Tash McCarroll

The FACTS 001 trial—named after the Follow-on African Consortium for Tenofovir Studies (FACTS)—was designed to test the safety and effectiveness of a vaginal microbicide that contains 1 percent tenofovir gel. The study aimed to replicate the groundbreaking results of a 2010 trial called CAPRISA 004, which found a 39 percent reduced risk of HIV infection. Unfortunately, the FACTS 001 study did not replicate those results on a larger scale. Although the answer wasn’t what we’d hoped, in the process of asking we have learned and grown, and we’ll  redouble our efforts to take the next steps forward.

In sharing this news, I am struck by a simple observation made by the editor in chief of “Science News,” Eva Emerson: “This is how science is supposed to work.” Her remark referred to a recent discovery in physics that upon further investigation could not be confirmed. Emerson’s conclusion was matter of fact. Scientists are in the business of asking questions, whether it is the existence of gravitational waves or the ability of a gel to protect vulnerable women.

The process of “asking” also re-emphasized the reason why we pursue new technologies for HIV prevention. The young South African women who participated in the study live in communities with some of the highest incidence rates of HIV infection in the world. Their lives are complex and the decisions they face daily are staggering. Everything we do, whether it be investigating new methods of HIV prevention or conducting thorough evaluations, is in the effort of bringing relief to these women and achieving an AIDS-free generation.

The FACTS 001 study was launched in October 2011 at nine clinical trial sites in South Africa and included 2,059 female participants aged 18-30. By the end of the trial in September 2014, about 4 percent of both the placebo group and the treatment group receiving the gel became infected with HIV.

In spite of this setback, USAID has already developed a robust pipeline of new products, many of which are jointly supported by the National Institutes of Health, the Bill & Melinda Gates Foundation and others. These include innovative methods such as vaginal rings, long-acting injectable antiretroviral drugs, and products that combine contraceptives and HIV prevention technologies. For each hurdle we encounter, USAID is determined to jump two steps forward—our commitment to helping women protect themselves from HIV has never been stronger.

To the women who participated in this trial: Thank you. You are why the trial was done, and you are why we will persevere.

The FACTS 001 trial was led by Wits Reproductive Health and HIV Institute, sponsored by CONRAD, and funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through USAID, the Bill & Melinda Gates Foundation, and the Government of South Africa, with support from Gilead Sciences.