Overtaken by microbicide trial results, USAID update on global health research raises questions of HIV prevention pipeline
In one corner of room 121 at the Canon House Office Building in Washington, DC, Tuesday, a biomedical engineer from Boston University stood next to a portable device, explaining that it can test medicines, including ones to save the lives of women during childbirth, to determine if drugs are effective (or possibly counterfeit) before they are used, rather than after they have failed to work. In another corner, the man who had brought a device called a “bCPAP,” which was hooked up to a baby doll, explained how it can breathe life into an infant in respiratory distress, a leading cause of newborn deaths in low resource settings. Designed for such settings, it is both more affordable and effective than previous alternatives.
At a third, untended, table between the two others, amid discarded napkins and business cards, a plastic ring that looked like maybe it was a baby bangle bracelet rested on the torn open wrapper it came in. A stack of flyers next to it indicated that it is the antiretroviral drug-loaded vaginal ring that researchers hope will give women in high-HIV burden settings a means to protect themselves from infection.
The occasion was the launch of the USAID’s December 2014 report to Congress, USAID Health-Related Research and Development Progress Report, An Update on the 2011 – 2015 Health Research Strategy, a document delineating the agency’s goals and progress for medicines and technologies to save lives and protect health in low-resource settings. The report highlights the agency’s investments in tools toward three goals:
- to end preventable child and maternal deaths,
- to control infectious diseases that include tuberculosis through improved diagnostic and treatment capacities,
- and to strive toward an “AIDS-free Generation.”
The bCPAP machine hooked up to the baby doll was one show of progress in the first category, the machine having improved the survival rate of infants in respiratory distress from 25 percent to 70 percent, according to speakers. The medicine-testing machine, which does not yet have the capacity to test TB drugs, but can be adapted to, upon donor demand, according to the engineer who brought it, was a concrete step in the second category. The unaccompanied plastic ring, according to the first section of the HIV part of the report, is one of the hopes for progress towards “an AIDS-free generation,” as a step towards “new HIV prevention methods that women can control on their own.” Unlike the two machines it was flanked by, it has not yet been shown to work, which may have been why no one stood next to it to tout its success. Results of a clinical trial testing the ring are not due until 2016.
The report, however, highlights work toward female controlled HIV protection not in evidence at Tuesday’s event. It describes the CAPRISA 004 trial that released results in 2010 showing “proof of concept that a 1 percent tenofovir gel can safely and effectively reduce a woman’s risk of HIV infection.” It also describes the larger, follow up FACTS 001 trial, which, using the same regimen as the first, CAPRISA, trial, which according to the report “is helping to achieve regulatory approval for this microbicide product.” With results expected in 2015, the report cites “the unprecedented opportunity in the next 5 years to obtain regulatory approval form the U.S. Food and Drug Administration for 1 percent tenofovir gel” and “the urgent need to plan for the introduction of this new prevention product in countries where it will have the greatest impact.”
By the time that was written, of course, disappointing news from earlier trials of female-controlled interventions, including the VOICE trial, had already raised questions about the utility of vaginal gel, as well as of oral antiretroviral HIV prevention measures, in the countries where they might have the biggest impact. And by Tuesday, the unfortunate findings of FACT 001 had provided “proof of concept” that the 1 percent vaginal gel being tested could not be used by the women testing it enough for it to be effective.
In the void left by those results, a sentence at the end of the section moves up in prominence, where the report notes: “USAID continues to collaborate with its partners and other donors to design and validate improved models for preclinical evaluation.”