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| Popping a Pill to Prevent HIV:
Can AIDS drugs stop HIV transmission?
Tuesday, April 25, 2006
6:30-8:00PM
LGBT Community Center, New York City
This event was the nation’s first comprehensive public forum on the important research on the use of anti-retroviral drugs to prevent HIV transmission (known as Pre-Exposure Prophylaxis or PrEP).
Some of the questions addressed in the forum included: Why are researchers pursuing PrEP as a possible effective intervention, and what are the current studies? What are the special issues in the LGBT community as we search for options beyond condoms or condemnation of our sexuality?
Researchers from PrEP clinical trials in San Francisco, CA and Lima, Peru spoke at the event.
Co-sponsors:
AIDS Vaccine Advocacy Coalition (AVAC) – http://www.avac.org
The Center for HIV Law and Policy - http://www.hivlawandpolicy.org
Community HIV/AIDS Mobilization Project (CHAMP) – http://www.champnetwork.org
Gay Men’s Health Crisis (GMHC) – http://www.gmhc.org
LGBT Community Center – http://www.gaycenter.org
Treatment Action Group (TAG) - http://aidsinfonyc.org/tag
COMMUNITY FORUM MATERIALS: SPEAKER PRESENTATIONS
Edd Lee, AVAC: Overview
PowerPoint Presentation
Richard Jefferys, TAG: Research Thus Far
PowerPoint Presentation
Albert Liu, PrEP Researcher, San Francisco
PowerPoint Presentation
Pedro Goicochea, PrEP Researcher, Peru
PowerPoint Presentation
Raffi Babakhanian, CHAMP: Prevention Activist Perspectives
PowerPoint Presentation
Edd Lee, Moving Forward
PowerPoint Presentation
COMMUNITY FORUM MATERIALS: OUTREACH VIDEO
Video from Peru used for clinical trial outreach
TE QUEREMOS
Summary of Discussion:
How long the PrEP treatment will last? Will dosing stay the same?
Currently PrEP refers to a regime of a pill a day for indeterminate amount of time, although researchers are looking into different durations and after the results of the first studies are released they can begin to look at different dosing.
How is adherence measured?
In Project T in SF, they measure adherence through several methods:
- Memory caps on pill bottles that track when they are opened
- Pill counts
- ACASI self-interviews (currently in English only, looking to get in Spanish too)
(Note: goal of Project T is to have 25% men of color)
What is the cost and how are pharmaceutical companies involved? At this stage have you considered the cost of retrovirals and future access?
It is still unclear how it is paid for or marketed in developed and developing countries. It was noted that through Gilead’s Global Access Program, Tenofovir is allowed to be distributed at cost. Currently a generic is being produced in South Africa but only for distribution in South Africa.
Note that any free trade agreements (some of which are currently under negotiation) between South America and US could directly affect a country’s ability to purchase generics.
Some of the trials closed partly because of work by activists who were suspicious that researchers were just looking to show efficacy in a lucrative market.
Both Truvada and Tenofovir are manufactured by Gilead. Gilead has cooperated by providing the drugs – but if drugs are shown to be efficacious they would not file for a change of indication with the FDA.
This is somewhat uncharted territory for pharmaceuticals, as they prefer treatment to prevention (treating sick people versus giving a drug to someone who is healthy).
If Truvada is showing to be more efficacious than Tenofovir in monkey studies, will the drugs used in trials change? Is money a factor?
Peru has applied to change their protocol to Truvada after the findings on Truvada were presented at CROI. While the monkey data doesn’t necessarily reflect what will happen in humans, and while Truvada is more expensive than Tenofovir, the science pushes you to Truvada and the need to test because we can’t know for sure until it’s tested in humans.
Accessibility is still an issue but something they’re working on.
Is there a corollary to this in medicine (i.e. taking a pill day, prophylaxis)?
- Birth control pills
- Malaria (but shorter term)
- To some degree can compare to MTCT
What has been the community response to Project T [San Francisco]?
There have been several community forums held in San Francisco. The Community Advisory Board (CAB) is very involved in the study and wanted to make sure study looked critically at behavioral disinhibition. There has been clear support of the trial across different community groups, largely due to the involvement stakeholders from the community
Note: Preliminary data about HIV antibodies, immune system attenuated could be looked at. The Peru site is looking to get additional grant to follow seroconverters (attenuated due to Tenofovir) and study highly exposed subjects who didn’t seroconvert.
Press Coverage:
http://www.gaycitynews.com/gcn_517/candrugspreventhiv.html
GAY CITY NEWS
Volume 5, Number 17 | April 27 - May 3, 2006
HEALTH
Can Drugs Prevent HIV?
Center forum explores studies aimed at testing pre-infection interventions
BY DUNCAN OSBORNE
A forum held at the Lesbian, Gay, Bisexual and Transgender Community Center explored the current studies and future potential of using anti-HIV drugs to keep HIV-negative people from becoming infected with the virus that causes AIDS.
“The studies that have been done so far have been done in animals and are based on theoretical models,” said Richard Jefferys, a speaker at the April 25 event, who is director of the basic science, prevention, and vaccines project at the Treatment Action Group (TAG), an AIDS organization. “Obviously, the big question is what will happen in people? What kind of toxicities will we see?”
Currently, there are five studies around the globe that are investigating the use of either tenofovir or truvada for so called pre-exposure prophylaxis (PrEP).
One U.S. study is recruiting 400 gay or bisexual men in Atlanta and San Francisco to take a daily dose of tenofovir or a placebo. The men will participate in the study for 24 months and that could determine the efficacy and safety of the drug.
“We’re not talking about the evening before or the morning after,” said Dr. Albert Liu, a speaker and the director of HIV Prevention Studies at the San Francisco Department of Public Health, a study site. “We’re talking about a continuous dose.”
Investigators also hope to measure if the men can adhere to the daily dosing schedule, weigh any side effects, and determine if they increase their sexual risk-taking as a result of taking the drug.
Another study in Peru will recruit 1,400 gay or bisexual men to take truvada, which a combination of two AIDS drugs, tenofovir and FTC, or a placebo for 20 months. Studies in Ghana, Thailand, and Botswana will recruit 3,200 men and women to take either tenofovir or truvada to determine its safety and efficacy at preventing HIV infection.
The two drugs are manufactured by Gilead Sciences, a California-based pharmaceutical company. Gilead was invited to participate in the forum, but declined. The drugs were selected because they have relatively few side effects and HIV is generally slow to develop resistance to them.
Four earlier PrEP studies in Cambodia, Cameroon, Malawi, and Nigeria were controversial because AIDS activists and political leaders charged that the structure of those studies was unethical and that using those drugs for PrEP might interfere with their use in treating HIV-positive people. While PrEP itself was not deemed objectionable in the earlier efforts, investigators on the current studies are being careful.
“We have learned that we really need political support,” said Pedro Goicochea Vergara, a speaker and co-investigator on the Peru study from the Association on the Impact of Health and Education. The Peru study has the support of that country’s health minister, Vergara said.
Some evidence suggests that sexually active gay men are already using anti-HIV drugs to try to keep from becoming infected with the virus. At least six 2005 articles in the mainstream press referred to this practice.
J. Jeff McConnell, a co-investigator on the Peru study and a project director at the Gladstone Institute of Virology and Immunology at the University of California at San Francisco, noted a 2005 survey of gay men in that city from the federal Centers for Disease Control and Prevention that found that seven percent said they had used an anti-HIV drug as a form of PrEP “at some point in the past.”
Speakers were careful to say that they were not endorsing PrEP even as they said that more research was needed on it.
“We’re definitely not a cheerleader for PrEP,” said Raffi Babakhanian, a speaker and member of the Community HIV/AIDS Mobilization Project (CHAMP). “I don’t think we’re at a point where anybody can be a cheerleader.”
CHAMP was the primary organizer of the event and the Community Center and TAG were among the co-sponsors.
Giving healthy people a drug to prevent them from becoming infected with a bug is rare. People who are traveling to an area where they may be exposed to malaria may take anti-malaria drugs before and during their trip, but that is the only similar practice.
“There isn’t a clear corollary,” said Edd Lee, director of community education and outreach at the AIDS Vaccine Advocacy Coalition (AVAC) and the forum moderator. “That’s why this research is so new.”
Other forum sponsors were AVAC, the Center for HIV Law and Policy, and the Gay Men’s Health Crisis.
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PRESS CENTER