By Lee Claypool, USAID Biologist
Microbicide. That’s kind of a funny-sounding — perhaps even scary — word for something pretty powerful. It certainly has a scientific “ring” to it, and that tends to turn people off. It’s complicated, it’s detailed, and it’s… boring, right?
If you think something that can empower women, save lives, and possibly change the course of history is boring, then yes. Here at USAID, we actually think it’s pretty exciting. For nearly 50 years, we’ve been investing in science, research, and innovation to enable game-changing interventions and breakthroughs to reduce poverty and improve livelihoods. This year, such an investment provided the first-ever proof that a microbicide, Tenofovir 1% vaginal gel, can safely and effectively protect women from HIV transmission.
An estimated 33.3 million people are living with HIV globally. Nearly 23 million of these individuals, 60 percent of whom are women, live in sub-Saharan Africa. In many countries, women lack the power to negotiate the use of prevention tools and approaches to protect themselves from exposure to HIV through conventional methods such as condom use, partner reduction, and negotiating delay of sexual debut.
The results of the USAID and South African-supported Center for the AIDS Program of Research in South Africa (CAPRISA) 004 trial are encouraging, and provide hope that a new method that will enable women to have greater control over HIV prevention will soon be available.
The next steps are to confirm these results in further studies; once this happens we could have on our hands a unique HIV prevention tool for women who are not able to negotiate other HIV prevention methods with their male partners. Once this new technology is ready, USAID will work with all our partners to make it available to vulnerable women and girls as soon as possible.
But, since everyone is different, we know that we need a variety of HIV prevention methods to choose from. For just this reason, other next-generation ARV-based product leads are in the pipeline and will be tested clinically if they continue to show good results in preclinical testing. We will continue to support clinical studies of promising products.
We are thrilled our Administrator thinks microbicide is an exciting word as well. Just two weeks ago he convened a meeting to determine the next steps following the success of CAPRISA. There will also be an additional meeting with technical experts in the field to discuss how to aggressively roll out microbicide treatments to those most in need.
Microbicide: Does one word say it all? Perhaps not. Is the word off-putting? Even a little too scientific? Perhaps. We just see it as the future of HIV prevention.
Want to know more about USAID-supported innovation and breakthroughs for global health? Stay tuned to www.usaid.gov and the IMPACT blog! We’ll be posting updates to highlight a variety of new research findings over the next several weeks as we roll out the 2010 Health Research Report to Congress.
hi. What are the side effects of tenofivir vaginal cream.does ot reduce the chances of getting pregnant,dose it pose any health risk to the fetus if a pregnancy is achieved while using the drug. and dose it have any bad effect on the sperm. thankyou
Hi Hilda,
My name is Daliha and I work on the Microbicides Team at USAID. Thank you for your questions, which are all very important for women who will be using this product. Of course, we need to do further research in all of these areas before we can make final conclusions, but here are some findings from our current studies on Tenofovir.
-What are the side effects of Tenofovir vaginal cream?
Studies in both animals and people have shown that Tenofovir is generally safe to use. Currently, Tenofovir (Viread®) is also provided in the pill form to individuals undergoing treatment for HIV infection. Some people have reported nausea, vomiting, diarrhea, and weakness while using the drug. In the CAPRISA 004 study of the vaginal gel form of Tenofovir, the drug was also shown to be safe. Some women did experience mild diarrhea, but overall, there were no serious side effects due to product use.
• Does it reduce the chances of getting pregnant? Dose it pose any health risk to the fetus if a pregnancy is achieved while using the drug?
o Studies of Tenofovir in the pill form have shown that there are minimal risks, if any, to pregnant moms and their babies. In the Tenofovir gel study, when women applied it vaginally, there were no effects on pregnancy outcomes or on the health of the babies born. We are planning to do more research in this area to confirm our results. We expect that Tenofovir as a vaginal gel will be safer than Tenofovir in the pill form because there will be less drug circulating in the blood. Tenofovir gel is applied in the vagina, so it will be present mainly in the vagina and will not spread to the rest of the body as much as the pill.
• And does it have any bad effect on the sperm?
o Animal studies so far have not shown any effects on fertility. Moreover, women who became pregnant in the study had healthy babies. Nevertheless, we are doing more research in this area to confirm our results. We believe it is important for women to have a safe product that they can use to protect themselves against HIV and we will continue to support research to have a safe and effective microbicide.
Thanks again for your great questions. Let us know if you have anymore.
Best wishes,
Daliha