Friday, August 31, 2012

HIV Prevention in a Pill; Is it a good or bad thing for struggling AIDS Drug Assistance Programs?

The ADAP Advocacy Association -- in partnership with Community Access National Network and Housing Works -- held its 5th Annual Conference in Washington DC at the Westin City Center from August 19th-21st. The theme: AIDS Drug Assistance Program Crisis: "STAMP" Out ADAP Waiting Lists!

The opening day of the conference featured a town hall-style meeting to discuss Pre-Exposure Prophylaxis for HIV prevention, or what has commonly been called PrEP. HIV Prevention in a Pill; Is it a good thing or a bad thing for AIDS Drug Assistance Programs? provided a platform for all sides of the policy debate to share its perspective on PrEP. The session was moderated by Michael Shankle, Director of Prevention and Public Policy with HealthHIV. He started off the session asking the panelists to describe in one word what PrEP means to each one of them. The words from the panelists included "promising, possibility, opportunity, and risky."

The panelists included William McColl with AIDS United, Darryl Fore with the Cleveland Ryan White Planning Council, Kathie Hiers with AIDS Alabama, Joseph Terrill with the AIDS Healthcare Foundation, and Joey Wynn with Broward House. McColl and Fore represented the pro PrEP side of the debate, and Terrill and Wynn represented the against PrEP side, while Hiers offered the middle-of-the-road perspective.

While most agreed it’s yet another tool in the tool box to combat the epidemic, feelings on the topic were VERY mixed. The positions varied and the reaction from the crowd was just as mixed. The following summarizes the panelist positions...

AIDS Healthcare Foundation position:
PrEP approval was fast tracked without regard for the potential increase in the risk of developing resistance if taken inconsistently, the possibility of increasing the likelihood of a Truvada resistant strain of HIV and the potential for increasing high risk behaviors among MSMs. The FDA approval moved forward without a hard requirement for an HIV test before a prescription, only "recommending" a test. Current concern is the push for Medicaid funding to cover PrEP. AHF doesn't think this would be a good use of public funds. The cost, implementation and monitoring of those for whom PrEP is prescribed are also concerns.

AIDS United Position:
AIDS United works with the Mapping Pathways project to help research the best means to provide information to policymakers and opinion leaders about the use of anti-retroviral drugs for prevention. AIDS United believes that PrEP is one of several new tools that will play a role in lowering new infections in the US. Like every new technology it requires ongoing and careful study to ensure that it is being used appropriately and with the least risk and that it is made available without regard for income or population disparities. That said it is a promising intervention and should continue to be explored.

AIDS Alabama Position:
PrEP adds another tool to the prevention toolbox that furthers our efforts to prevent new infections, a goal shared by everyone. However, the biggest question is a financial one. Do stakeholders push for public payment when many persons currently living with HIV disease are unable to obtain a steady supply of ARVs? Obviously all persons living with HIV/AIDS should be our top priority in ensuring that treatment is available. What are the future medical consequences for persons who do not adhere and who contract the virus, as well as long-term safety and fetal exposure issues in general that are unknown? On the other hand, persons who can afford to utilize PrEP should have every right to do so. AIDS Alabama believes that there is a benefit for persons consistently at high risk, including sex workers and people in discordant relationships.

Darryl Fore (Patient Advocate):
The PreP study is an opportunity to collect relevant data to supplement the data derived from the HIV vaccine trial. How will the PreP study affect the various HIV+ and HIV- populations, including gay men, women, seniors, youth, sex workers, IV drug users and prison populations. What are the conceived and un-conceived risks in participating in this study?

Broward House Position:
PrEp involves giving expensive HIV Medications to HIV negative individuals for an extended period of time to prevent HIV transmission. The basic concept for this intervention has good intentions, but the reality of existing implementation makes this a very bad idea as it is currently structured. South Florida local consensus statement: The Broward County Prevention Planning Partnership held a meeting May 11th 2011; a consensus statement was read, debated, and a consensus was reached. It reads, “Affected areas with large HIV communities should oppose this intervention until after 2014 and further clinical trials are completed & results analyzed.” Many local advocates, agencies & popular opinion leaders are opposed to this effort, and see no benefit from a public health or community perspective. The risks far outweigh the benefits."

A significant portion of the discussion centered around the five points of concern raised by Joey Wynn, which included:

1) Data surrounding condom use is mixed. Many gay men report the perception that they can now “Not have to use condoms if they take this medication” this absence of condom use is growing as an expectation for gay men not well versed in the iPrEx study. (@ IML referring to this as “Alternative to condoms” causing a strong response for & against the topic at the event).

2) Higher risk activities are already increasing in South Florida, as evidenced with soaring STD rates and increasing HIV rates. This “newfound invincibility to HIV” undermines our existing HIV Prevention strategies; not to mention - Hep. C, MDR gonorrhea, and other STDs.

3) Financing of the expected system of support & care not available in most areas, especially in the south, where HIV rates among gay men of all races is highest. The weekly counseling, ample supplies of condoms, support groups & risk education, as well as time for physicians to teach how to properly use this medication are not widely available. Little to nothing was provided to those gay men already using this medication that we surveyed; a prescription was written and filled. Perceptions among gay men vary widely on how often to take this, often disregarding the label instructions. Some choose to take this “only on weekends”, or just before a sexual encounter. Staffing resources do not have additional capacity to provide this service and will have to choose between traditional prevention efforts or PrEP.

4) Using Truvada as the agent is a REALLY BAD IDEA! A) this optimal backbone regimen is involved with a huge majority of treatment options currently in use in the United States. B) When taken incorrectly, or by people that think they are negative but are not, resistant strains WILL emerge. A better solution would be generic Combivir. It is vastly less expensive, poses no serious risk to the treatment therapies in use across the country in terms of resistance, and offers a history of efficacy in mother to child transmission reduction over the past 15 years.

5) This controversial intervention distracts us from our larger mission to achieve the National HIV AIDS Strategy(NHAS). We need to focus on getting positive people into care, get them on therapy and get them to undetectable viral loads, and substantially reduce new infections. HPTN 052 shows at least a 96% reduction in infections. This is double the possible best case scenario of PrEP and is the better route for the reduced funding we are experiencing nationwide.

The Town Hall meeting didn't appear to change anyone's mind, but it most certainly provided an excellent forum for the free-flowing exchange of ideas. At the end of the Town Hall meeting, Shankle had everyone write down the one word they thought of PrEP, to sum up the words everyone seemed cautiously optimistic at this time. HealthHIV developed this word cloud to summarize the feelings from those stakeholders in attendance: