A little more than 10 years ago, a New York Times reporter interviewing International Partnership for Microbicides chief executive Zeda Rosenberg pointed to estimates putting the earliest possible marketing of topical product women could use and control to protect themselves from HIV about seven years away and asked if women at greatest risk for infection had seven years to wait.
No they don’t, Rosenberg replied, adding that all the same, testing the safety and effectiveness of the most promising product would take at least that long. Developments and setbacks in the microbicide field during the years since have only underscored the combination of patience, persistence and urgency that have characterized the quest for biomedical tools that can put the barriers to HIV transmission into the hands of people who need them most. Most recently, they have included the CAPRISA trial that provided proof that topical application of an HIV-fighting drug could prevent transmission, and the results of the VOICE trial, which indicated that possible barriers for some women using such a product remained unidentified. In the course of both of those developments the potential for a microbicide containing vaginal ring that could remain in place for a month gained prominence as a promising next step.
Now two grants from USAID totalling as much as $40 million puts completed development of a vaginal ring releasing the antiretroviral dapivirine as near as three years away, with distribution following swiftly, and new product in the pipeline, word from IPM says.
The time between now and 2016 will be spent completing phase III trials on the dapivirine ring, moving toward the regulatory approval that will be needed to distribute the product, and working to make it widely and affordably available, Rosenberg told Science Speaks last week.
Rosenberg evinces optimism fueled in part by setbacks — the current product represents the fourth attempt to make an effective ring, each an improvement over the previous version. “Now it is a highly stable ring,” she says, pointing to a potential four-year shelf life, important to developing country settings. And, of course, replaced monthly, that is will not be “what used to be called coitally dependent,” (and now Rosenberg adds, is called on demand), addresses a major issue driving vaginal microbicide research: “The reality of many women’s lives is they don’t plan for sex,” Rosenberg notes.
So, with the problems it has been developed to address, and the high hopes that it will, how do researchers prepare for the possibility of disappointment?
“I’m not sure you can ever be prepared for it,” Rosenberg said. Researchers will know more than they do now, she added. In addition, they will know, in the course of the trial whether the product was used as intended — used rings will provide that indication.
She notes the inarguable point that has to be the mantra of anyone invested in outcomes that must be demonstrated through clinical trial research:
“There’s no such thing as failure, because what you learn takes you to the next step,” she says. But, she adds, as time passes between each step, women continue to be infected.
“That’s the hard part,” she says. “But do I think we will get there? Yes. I just hope it’s not too many more steps.”