A new gel that empowers women to help prevent the spread of HIV/AIDS surprised and impressed experts such as Chicago's Jim Pickett at the recent 18th International AIDS Conference held in Vienna.The researchers and findings “received a standing ovation,” said Pickett, who attended as director of advocacy for the AIDS Foundation of Chicago.
The audience for the presentation on the gel was so unexpectedly large that conference organizers needed to open two or more rooms to accommodate the overflow crowd.
Scientists reported the results of a CAPRISA (Centre for the AIDS Programme of Research in South Africa) clinical trial testing the effectiveness of the vaginal application of tenofovir, an antiretroviral-based microbicide gel.
The gel contains 1 percent tenofovir as the active ingredient that helps prevent the contraction of HIV/AIDS. There is also a pill form that can be taken orally.
For those who have been involved in the war against HIV/AIDS, these results have created a stir of optimism and hope over the potential of this new weapon.
Researchers from the University of KwaZulu Natal in South Africa conducted the trial and found that the gel had a success rate of 54 percent for women who used the product as directed, meaning they used it more than 80 percent of the time. It had a approximately 39 percent success rate even for women who had an intermediate adherence rate, using the product as directed between 50-80 percent of the time.
The findings mean women who may not be able to convince male partners to take protective measures such as using condoms can now control preventive actions themselves.
In terms of this drug becoming available to the public, “It depends on the country," Pickett said. If South Africa decided to license tenofovir, they could do so readily, he said.
When it comes to availability in America, “There is a lot of momentum now and there are a lot of people in the community who are saying they want this gel right now, at 39 percent efficacy,” Pickett said.
At the same time, scientists want to make sure that these findings are corroborated on a larger scale and in multiple other countries before the drug is considered for distribution in this country.
The study conducted in South Africa included 900 HIV-negative women between the ages of 18 and 40 who were sexually active. The women were asked to vaginally apply the drug 12 hours prior to sex and 12 hours after.
The women were later tested for HIV. This study also showed positive results with regards to preventing herpes.
Pickett said that the scientific and medical community was not feeling so hopeful about the future of microbicides before these findings. There were many doubts about if microbicides could reach this level of efficacy, but this study has changed the game for those researching and studying HIV/AIDS.
When the findings were finally stated at the conference, "People were high-fiving. People were tearing up and crying. People have been working in this field who were waiting for this day,” Pickett said.
“It has recalibrated the entire prevention field. There was very much a before CAPRISA and after CAPRISA,” he said.
Yaa Simpson, community epidemiologist for TACTS (The Association of Clinical Trial Services) in Chicago, is involved in raising awareness of clinical trials and evidence-based research regarding HIV, STDs and hepatitis.
Simpson said she does not want people to see this as a possible "end all, be all," however. She said she fears that some people will have a false sense of security and have the mindset of “if I pop this pill I can take on the world.”
She added she believes it is important for people to view this as an extra level of protection to be used with another layer of protection such as a condom. “The more we have for prevention the better it is,” said Simpson.
Simpson said she likes the concept of a gel because the use is similar to birth control methods and “provides a way for women to have control over what they engage in.”
Simpson and Pickett both added that the gel could be an extra layer of protection to women who may be in violent relationships or are not in complete control over their sexuality for various reasons.
Yvette Williams, case manager for the AIDS Department at Lawndale Clinic, Yvette Williams said that she commonly runs into cases where women do not want to use condoms because their partner is opposed to them.
At the same time she says that it is a positive and a negative because it would provide some protection from HIV, but doesn't prevent pregnancy and other STDs.
People who are HIV positive may think that they can use this gel to protect an HIV negative partner, but Pickett noted that's not the case. “Antiretroviral-based prevention is not to be used by people with HIV," he said. Doing so could mean developing drug resistance.
If and when tenofovir becomes available as a prevention method, people will still need to be tested regularly.
Although the studies findings have invigorated the prevention field, there are more studies that need to be done in regards to the best application for this drug’s effectiveness level, as well as doing more studies that corroborate these findings.
Pickett, also heads IRMA (International Rectal Microbicide Advocates), a group of advocates, scientists and policy makers who are interested in developing rectal microbicides. He hopes that this study projects a future for topical tenofovir, where people are able to use microbicides to protect themselves from infection regardless of the type of sex they are engaging in.
Currently, a phase 1 safety trial of rectal tenofovir is scheduled for testing in Birmingham, Boston and Pittsburg with a small group of 60 individuals later this year. A larger phase 2 trial coul begin in late 2011 to 2012.