Developing multiple prevention strategies, Part II—In conversation with U.S.-Based Jessica Terlikowski

Original content from the Mapping Pathways blog team

“We need to ensure access to all forms of prevention and treatment is readily and easily available for anyone who needs it, so people can reduce their risk, get the prevention and care they need, reduce onward transmission and lead healthy lives.”

Jessica Terlikowski is director of regional organizing at AIDS United based in Washington, D.C. and was most recently a policy manager at the AIDS Foundation of Chicago. Both organizations are Mapping Pathways partners. Jessica is co-founder of the Chicago Female Condom Campaign, and coordinates the National Female Condom Coalition. She was recently honored by the AIDS Legal Council of Chicago  as “Advocate of the year” for outstanding work in making a difference in the lives of people with HIV and AIDS. 

 In part 1 of her interview, Jessica discussed the importance of scaling up interventions we know that work while moving forward with new strategies like PrEP. In part II of the interview, she discusses some of the challenges that have to be overcome in the HIV prevention landscape.

MP: In our previous conversation, you mentioned a lack of political will to invest in resources? Could you elaborate on that?

JT: In the United States, there are a number of state and federal lawmakers who are proposing deep cuts to health care, prevention, and other public assistance programs in the name of “fiscal responsibility.” They claim that by reducing the government’s spending on such programs, we can begin to turn the U.S. economy around. However, such cuts would be devastating to those of us who already struggle financially and have limited to no access to healthcare – the majority of people with HIV. Additionally, decimating health and social safety net programs results in higher future costs which simple doesn’t make good economic sense.

Federal funding for syringe-exchange programs has recently been banned once more, just two years after our Congress lifted a 21-year ban. These programs provide sterile syringes, male and female condoms, HIV and hepatitis counseling and testing, vaccinations, and many other lifesaving services to injection-drug users and their partners.  Syringe exchange is one of the most successful and cost-effective interventions we have. 

We’re in a situation now where we are getting conflicting messages from our leaders. On the one hand, we have Secretary of State Hillary Clinton saying, “we can have an AIDS-free generation “, while at the same time Congress is making decisions that undercut efforts to actually get us to that point.

MP: Why is the work that Mapping Pathways is doing important right now?

JT: Our work especially matters because we have a number of tools now and coming down the pike to stem the HIV epidemic. We have several strategies at our disposal including PrEP and TLC+. While the stakeholder interviews and community input sessions are hugely beneficial to us, they also inform, educate and create a discussion among the stakeholders and the communities they belong to.

Many people’s knowledge of ARV-based prevention strategies is limited. They also have a lot of questions and concerns. . We are creating a space for people to learn and to discuss each of the options and how they relate to each other. Mapping Pathways participants then communicate and discuss the broader issues with their own communities. This is something that we are working on now—the dissemination of the community and expert perspectives we collected in the first year of the project.

Mapping Pathways is also important here in the U.S. because HIV continues to be a big problem here that especially impacts people who are already marginalized: people with low incomes, gay men, transgender women and women of color, people who use drugs. These are communities whose needs must be prioritized if we are to reduce the number of new HIV infections.

Mapping Pathways is all about having conversations about ARV-based prevention strategies. We need to make sure that these strategies are not going to be reserved just for people who already have access to healthcare.  We need to ensure access to all forms of prevention and treatment is readily and easily available for anyone who needs it, so people can reduce their risk, get the prevention and care they need, reduce onward transmission and lead healthy lives.

MP: Is this possible in the U.S. context right now?

JT: It is, but it won’t happen overnight. AIDS is a social justice issue and not just a public health issue. We have to talk about many other issues when we talk about HIV, like sex, drugs, and poverty, which are not things many people feel comfortable talking about. Our job as advocates is to raise these issues with decision makers and educate and organize our communities to build the necessary political will.

  

MP: What is the most satisfying part of your job?

JT: I think the most satisfying part of my job is working with others who share a common passion and drive on these issues. We are all deeply committed to working with our communities to increase political will for greater investment in and attention on HIV prevention, treatment, and care issues.

Read the first part of Jessica’s interview here, and learn more about the Mapping Pathways learnings from the U.S. here. 

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AIDSmeds: Adherence Challenges in Intermittent HIV PrEP Study

via AIDSmeds.com

Intermittent use of Truvada (tenofovir plus emtricitabine) as pre-exposure prophylaxis was associated with poor adherence, compared with daily use of the tablet to prevent HIV infection, according to results of a small clinical trial published in the online scientific journal PLoS ONE.

Using electronic pill caps, the Kenyan study found that the adherence rate associated with daily PrEP use was 83 percent. Among those using intermittent therapy—Truvada taken on Monday, Friday and within two hours following sexual intercourse—the adherence rate was 55 percent. Among those who only took Truvada within two hours following sexual intercourse, the post-coital adherence rate was only 26 percent.

Truvada as PrEP was recently recommended for U.S. Food and Drug Administration (FDA) approval by the Antiviral Drugs Advisory Committee. The recommendation is based on data from several clinical trials, all exploring the safety and efficacy of Truvada PrEP used daily.

There has been interest in exploring alternative dosing strategies, notably scheduled and as-needed intermittent use of the drug. Experts hypothesize less frequent dosing may reduce the risk of side effects and prove easier for people to use, in light of the poor adherence that has been noted in clinical trials evaluating daily use of Truvada.

Read the Rest.


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FDA Hearing on Truvada as PrEP - Watch the Webcast!

On May 10, 2012 the FDA Antiviral Drug Advisory Committee strongly recommended that emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) be approved for use as pre-exposure prophylaxis (PrEP) among sexually active adult men and women – particularly gay men and other MSM, serodiscordant heterosexual couples, and other individuals at high risk. It is likely the FDA will follow the committee’s recommendations and issue a new prevention indication for the use of Truvada by mid June.

Watch the recorded webcast here.

Check out the slide presentations here.


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The Lancet:PrEP for HIV prevention reaches key milestone

via the Lancet.com, by Salim S Abdool Karim and Quarraisha Abdool Karim

On May 10, 2012, a US Food and Drug Administration (FDA) advisory committee voted in support of the use of tenofovir-emtricitabine for HIV prevention.1 If the FDA, which is scheduled to make its decision by June 15, adopts the committee's recommendations, tenofovir-emtricitabine will become the first antiretroviral drug to be approved as pre-exposure prophylaxis (PrEP) for the prevention of HIV, paving the way for implementation.

PrEP has a unique advantage in young women in southern Africa, who bear a disproportionate burden of the HIV epidemic. In much of this region, young women are often unable to convince their male partners to use condoms, remain faithful, or have an HIV test. To rely on her HIV- positive discordant male partner to come forward to test, to agree to take antiretroviral therapy (ART), and to take his ART with high adherence, all for her protection, puts a woman's risk of acquiring HIV back in the hands of men, thereby disempowering women and undermining their efforts to control their risk of HIV.

However, there are several criticisms and concerns about PrEP. First, that data on the effectiveness of PrEP, especially in women, are inconsistent. This concern is based on the results of two PrEP studies—the FEM-PrEP2 and VOICE3, 4 trials—which were stopped, at least partly, earlier than planned when they did not show efficacy. To some extent, this concern has been allayed by recent data from the FEM-PrEP trial5 which show that adherence to daily tenofovir-emtricitabine in the trial was too low allow assessment of efficacy. Data to explain the VOICE trial, which still has an ongoing tenofovir-emtricitabine group, are not expected until 2013.

Second, some suggest that antiretroviral drugs should be provided to HIV-negative people only when all eligible HIV-positive patients are receiving ART. Although it is a legitimate concern that eligible HIV-positive patients should be prioritised for ART for their own health and to save their lives, it is spurious to trade off treatment and prevention as if these drugs are being taken away from sick and dying patients to be given to healthy people. Treatment and prevention strategies are a continuum in their use of antiretroviral drugs—both are needed in conjunction with each other to ensure ART provision is sustainable in the long term and to realise the quest to end the HIV epidemic.

Read the Rest.


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Developing multiple HIV prevention strategies - In conversation with U.S.-based Jessica Terlikowski

Original content from the Mapping Pathways blog team

 

“We must build the political will for investment in each these HIV- prevention strategies”

Jessica Terlikowski is director of regional organizing at AIDS United based in Washington, D.C. and was most recently a policy manager at the AIDS Foundation of Chicago. Both organizations are Mapping Pathways partners. Jessica is co-founder of the Chicago Female Condom Campaign, and coordinates the National Female Condom Coalition. She was recently honored by the AIDS Legal Council of Chicago  as “Advocate of the year” for outstanding work in making a difference in the lives of people with HIV and AIDS. 

 MP: How did you get involved in the field of HIV prevention?

JT: I got involved in the field of HIV prevention through my commitment to women’s reproductive health and rights, which is where I got my professional start. I have been a staunch reproductive rights advocate ever since I can remember.  When I moved to Chicago, there was a position available at the AIDS Foundation of Chicago and microbicide education and advocacy education was a part of the job.  I didn’t have an in-depth knowledge of the field at the time and was eager to learn.  

 MP: Is there a prevention strategy that you are especially passionate about?

JT: I think the key is to have as many prevention strategies available as possible. I am, however, extremely passionate about female condoms as they are an important tool for any receptive partner—woman or man—to reduce their risk of HIV and other STDs. They are particularly important for women though as female condoms are the only HIV and STI prevention options that also prevents unintended pregnancies. The global South has recognized the value of this tool for quite some time and the U.S. is starting to get there now too. We are seeing more and more community based organizations, clinics and health departments prioritize female condoms as a result of increased advocacy from a handful of us. The U.S. female condom movement is growing and building momentum.

What I am really concerned about is making sure that people are aware of what prevention strategies exist, so they know what is out there and can access what they need when they need it. We owe it to the communities to push for both existing tools like male and female condoms, sterile syringes, PEP, as well as emerging biomedical tools like microbicides and PrEP.

MP: What Mapping Pathways activities have you and AIDS United engaged in recently?

JT: We adapted the analyses from stakeholder interviews and online survey the Mapping Pathways team conducted in 2011 and created a PowerPoint slide deck which provides  a strong overview of the Mapping Pathways methodology, definitions of ARV-based prevention terms and an overview of ARV-based prevention strategies (read more about the presentation here). We conducted community input sessions with stakeholders at the CDC’s National HIV Prevention Conference and with a number of stakeholders at and AIDS United convening of southern grantees.  

A key finding  was that when we talked about ARV-based prevention strategies, people’s minds would go straight to PrEP instead of thinking of the full portfolio of ARV-based prevention strategies—TLC+, vaginal and rectal microbicides, and PEP. We also learned that there is a real need for developing a common vocabulary around these options to ensure we are all talking about the same thing. At times stakeholders would interpret use the term “treatment as prevention” to refer to PrEP when it is actually referring to TLC+.

A major theme arising from the stakeholder interviews, the survey outcomes as well the community input sessions was that though people are excited about the possibilities of ARV-based prevention strategies as a whole, they are also concerned about how the vast majority of the people who need these options could pay for them.

MP: What are some of the issues, financial and otherwise, that keep coming up in the field of HIV prevention?

JT: I think one of the biggest issues that keep coming up is that of resource allocation. Many are asking where the HIV field can and should invest its resources in order to have the most impact. Since HPTN052, some say that we should pull resources from traditional prevention programs to invest in TLC+ and suggest that people don’t use condoms anyway. Others say that due to resource limitations, it simply isn’t feasible to get everyone who is HIV-positive on treatment.

The reality is that there is no magic bullet that is going to turn the tide on the epidemic in the U.S. or around the world.  We need as many options available as possible and we need to scale up the interventions that we know to work, including increasing availability to sterile syringes and male and female condoms, while also continuing to invest in research for emerging options ensuring that HIV-positive people who need treatment can access it. We can’t afford to play either/or here. Instead, we must build the political will for investment in each these strategies.

Check back next week for part II of the interview in which Jessica discusses ways we can make HIV prevention and treatment a reality for the people who need it most.

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Patients in South Africa Increase the Use of Antiretroviral Treatment

via aidsmap.com, by Carole Leach-Lemens

South Africa exceeded national targets for new patients starting antiretroviral treatment (ART) by around 50% between 2007 and 2011 – achieving treatment coverage of close to 80% of eligible adults – according to new research carried out by Dr Leigh F Johnson, actuarial scientist at the University of Cape Town, published  in the March issue of The Southern African Journal of Medicine.

From mid-2004 to mid-2011, the total numbers of people receiving ART increased from 47,500 (95% CI: 42,900 to 51,800) to 1.79 million people (95% CI: 1.65 to 1.93 million). The latter figure represents close to 80% of adult treatment coverage, according to eligibility criteria in use during this period (CD4 cell counts under 200 cells/mm3). Using current South African CD4 cell count eligibility criteria (under 350 cells/mm3), coverage achieved decreases to 52% (95% CI: 46-57%).

While the targets were still exceeded, children and men started ART at considerably lower ratios than women.

Women accounted for 61%, men 31% and children 8% of the total.
Effective HIV treatment significantly reduces illness and death resulting from HIV, as well as onward transmission of HIV. Evaluating the effectiveness of HIV treatment and prevention programmes requires monitoring access to ART.

Previous monitoring assessments have shown a dramatic increase in access to ART in South Africa. While these assessments have suggested South Africa was on track to meet the targets of its HIV & AIDS & STI National Strategic Plan 2007-2011 (the NSP), no formal assessment has been made, Dr Johnson adds.


Read the Rest.


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Orasure In-Home HIV Test Gets Unanimous Approval Recommendation

 via AIDSmeds, by Tim Horn

Orasure’s oral swab-based rapid in-home HIV test has been recommended for approval by the U.S. Food and Drug Administration’s Blood Products Advisory Committee. If the FDA follows its advisory committee’s recommendation, the Oraquick In-Home HIV Test will be the first complete home-based screening assay for any infectious disease available for purchase over-the-counter (OTC) from pharmacies and internet retailers.

The advisory committee voted unanimously, 17-0, in favor of the test upon being asked two questions: Do the available clinical trial results provide reasonable assurance that the test is safe and effective? And, importantly, do the benefits of in-home HIV testing outweigh the potential risks, notably false negative and false positive results?

The particulars of the second question were hotly discussed throughout the May 15 meeting in Gaithersburg, Maryland. Of concern to the FDA presenters and advisory committee panelists is the test’s reduced sensitivity—its effectiveness at screening for HIV antibodies in those infected with the virus—compared with the professional oral swab OraQuick assay.

Read the rest.

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Slim Abdool Karim: Shaking up SA’s ailing medical research

via Business Day (South Africa), by Tama Kahn

PROF Salim Abdool Karim, the newly appointed president of the Medical Research Council (MRC), sweeps into his office exuding energy and beaming from ear to ear, hardly the disposition you’d expect from someone who had less than four hours sleep the night before. His ability to thrive under pressure will stand him in good stead as he seeks to turn around an institute in the doldrums: the MRC’s international reputation has slid, its staff are demotivated, and it is chronically underfunded.

Hand-picked for the job by Health Minister Aaron Motsoaledi, Karim is used to difficult challenges. He was a political activist and medical student at the height of apartheid and went on to become one of the world’s leading HIV researchers, investigating vaginal gels to protect women from infection. His background left him unafraid to talk truth to power.

He was a member of former president Thabo Mbeki ’s scientific AIDS advisory panel, established in 2000 to answer Mbeki’s controversial questions about the disease long after the scientific community had accepted that HIV caused AIDS. He was openly critical of the dissidents who disputed this link and of the very idea that a panel could vote on matters of scientific fact. He was also on the organising committee of the Durban Declaration, a petition signed by leading scientists affirming that HIV causes AIDS to try to counter the damage done by the dissidents.

Three years ago, he co-authored a warts-and-all analysis of the many problems that beset SA’s health landscape, which was published to much acclaim in the prestigious medical journal, the Lancet. The series of papers offered a snapshot of the dismal state of healthcare in SA at the end of former health minister Manto Tshabalala-Msimang ’s tenure, and is often quoted from by Motsoaledi.

Karim briefed the minister about The Lancet series before it was published, warning him it would not be good news.

Read the rest.

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FDA Panel Backs Approval of First Drug to Prevent HIV

via Associated Press, by Matthew Perrone

Excerpt:

Nick Literski, a federal worker in Seattle, has been taking Truvada for HIV prevention for more than a year. His partner is HIV-infected and his doctor prescribes the drug as a precautionary measure, even though it is not yet FDA-approved for that use. Literski pays a $40 monthly co-pay for the once-daily pill.

FDA approval of the drug for prevention would be “a huge step forward” in the fight against AIDS, he said in an interview Thursday. But he said rejection would be devastating, threatening gay relationships like his that involve one partner who is HIV infected and one who isn’t.

“Many HIV-positive men end up ending their relationships with HIV-negative men out of fear of infecting their partner,” Literski said, and he worried about that happening to him before he started using Truvada.

Read the rest.

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BIG NEWS: FDA panel backs first pill to block HIV infection

via The Associated Press

A panel of federal health advisers has endorsed the first drug shown to prevent HIV infection in healthy people, clearing the way for a potentially landmark approval in the 30-year-old effort against the virus that causes AIDS.

In a series of votes, the Food and Drug Administration advisory panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-infected person. The FDA is not required to follow the panel's advice, though it usually does. A final decision is expected by June 15.

Drugmaker Gilead Sciences Inc. already markets Truvada as a treatment for people who are infected with HIV.


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The Impact Generic Drugs Have on the Cost of HIV Treatment

via Huffington Post, by Dean Baker

Drugs are cheap. Patent monopolies are expensive. These are simple facts that everyone should know but for some reason few do.

The point here is simple; the vast majority of drugs are cheap to produce. Chain drug stores sell hundreds of generic drugs for $5-$7 per prescription. They can do this profitably because few drugs require expensive chemicals or manufacturing processes.

However, many brand drugs sell for hundreds or even thousands of dollars per prescription. This is due to the fact that drug companies have patent monopolies on these drugs. The government will arrest anyone who produces these drugs without the permission of the patent holder. Since drugs can be essential for people's health and/or life, if they can find a way to pay any price demanded by the drug companies, they will.

The higher prices due to patent monopolies are the reason that many people have difficulty paying for drugs. If all drugs were sold in a free market as generics, paying for drugs would not be a serious issue except for the very poor.

Of course, patent protection is the way in which drug companies finance their research. It costs a lot of money to research new drugs and then test them to establish their safety and effectiveness and bring them through the Food and Drug Administration's approval process.
However, there are more efficient mechanisms than patent monopolies to finance drug research. Vermont Senator Bernie Sanders is proposing one such mechanism, a prize system, be adopted to support research on AIDS drugs.

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

India's Involvement to the Change of HIV/AIDS

via the Hindustan Times, by Sanchita Sharma

A decade ago, New Delhi’s The Ashok turned away a dozen gay men who wanted to book a conference room at the hotel for a think-in on AIDS, which was still labelled a gay man’s disease. It took several phone calls from the senior bureaucracy at the Union Health Ministry’s National AIDS Control
Organisation (NACO) to get them a 12x12 conference room for one day.

“Five years ago, the same group of men who have sex with men (MSMs, the politically correct term for homosexuals) organised a huge convention at The Ashok, with 700 MSM and transgender participants overrunning the hotel for days. Laws may not have changed in the courts or in the books, but the law in the streets has changed, and this amazing turnaround in society’s attitude has happened because of AIDS,” says JVR Prasada Rao, former Union health secretary and National AIDS Control Organisation (NACO) chief, who was appointed the UN Special Envoy for AIDS in the Asia Pacific region this week.

Safe and sound, legally

 Change in social attitude is fantastic, no doubt, but it is not enough to keep new infection down. Legal environment around people most at risk — homosexuals, injecting drug users and sex workers — has to change to encourage them to seek HIV-prevention and treatment services that have been proven to cut down new infections dramatically, not just in India but everywhere around the world.

Last year, the HPTN052 study — HIV Prevention Trials Network’s study that was declared the Breakthrough of the Year 2011 by the journal Science — showed that if an HIV-positive person adheres to antiretroviral therapy (ART) used to treat AIDS, the risk of transmitting the virus to their uninfected sexual partner is reduced by 96%.

In March this year, the Africa Centre for Health and Population Studies reconfirmed the HPTN findings by presenting data showing that in areas where ART uptake is high (greater than 30%) people who do not have HIV are 38% less likely to get infected with the virus as compared to areas of low uptake (less than 10%).

With 7.4 million on HIV treatment globally, new HIV infections have fallen in 33 countries since 2001, though mostly in Africa and Asia. UNAIDS credits the halving of India HIV-infected people to 2.39 million to both improved data collection methods and an actual fall in new infections because NACO provides 4.48 lakh people free anti-retroviral therapy (ART), which lowers the HIV load in the body and lowers the risk of infecting partners while helping the infected live healthier and longer.

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PEPFAR Program Outlines End of Year Progress to the Congress

via Science Speaks, by Meredith Mazzotta

PEPFAR releases 8th annual report to Congress: The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program delivered its 8th annual report to Congress recently. The five-page document outlines the program’s progress as of the end of fiscal year 2011 in various areas including:  supporting 3.9 million people on antiretroviral treatment; testing 9.8 million pregnant women for HIV in the course of the year; providing prevention of mother-to-child transmission services to more than 660,000 HIV-infected pregnant women allowing 200,000 babies to be born HIV-free; and providing care and support for nearly 13 million people, including more than 4.1 million orphans and vulnerable children. The report also stressed the importance of “leading with science” as we respond to the pandemic, smart investments including spurring private-sector engagement, country ownership, and shared responsibility.

TB institute confirms 8 patients resistant to all known TB drugs:  According to this article in the Hindustan Times, eight of the 12 patients originally reported as having what was coined “totally” or “extremely” drug resistant TB (neither term is recognized by the World Health Organization) have received confirmatory sputum sample testing that show resistance to all first- and second-line TB drugs. Since the original diagnoses of the dozen patients, three have died and, according to a city TB officer, of the six patients that remain in Mumbai, five are undergoing treatment for extensively drug-resistant TB, and one is being treated at Hinduja hospital.

Nonprofit TB Vaccine Developers Sign MOU to Accelerate Progress: Aeras announced it will be joining with the Tuberculosis Vaccine Initiative (TBVI) to “enhance and strengthen collaborative efforts to advance the world’s most promising TB vaccine candidates.” The memorandum of understanding between the two organizations will work to address opportunities and challenges in TB vaccine development that were outlined in the strategic blueprint released by advocates in late March, and published in the journal Tuberculosis, just before World TB Day. According to the Aeras press release, the two organizations will advise each other on vaccines in development, work to streamline the process of candidate selection and review, as they work together to achieve the goals outlined in the blueprint.

Read the Rest.


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FDA Reports that Truvada May Be A Safe and Effective HIV Prevention Method

via Bloomberg, by Ryan Flinn and Shannon Pettypiece

Gilead Sciences Inc. (GILD)’s pill Truvada was safe and effective when used to protect uninfected people from getting HIV, U.S. regulators said in a report indicating the main concerns are when and how it should be used.

Truvada was “well tolerated” and its ability to reduce the risk of infection was backed by two studies, the Food and Drug Administration staff said in a report today. Gilead, based in Foster City, California, is seeking to sell the drug as the first pill to keep people from becoming infected.

The FDA asked its advisers to suggest who should get Truvada; what testing would be needed for administration; and what educational material should be used for patients and doctors. The advisers will meet May 10 to discuss the drug, the subject of debates over its appropriate use and cost.

Decisions to prescribe Truvada “should carefully weigh the individual risks for acquiring HIV, their understanding of the importance of adherence to medication, and their potential for development of renal toxicity,” the FDA staff said today in a report on the agency’s website. Education and counseling will be “critically important.”

Gilead fell less than 1 percent to 9:57 a.m. New York time. The FDA isn’t required to follow what the advisory panel suggests.

Read the Rest.


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Microbicides 2012 Conference: “Someday, our ARV-prevention tools will be as sexy as the I-Phone!”

Original content from the Mapping Pathways blog team

This is the second part of a two-part blog series on highlights and discussions from the Microbicides 2012 conference that recently concluded in Sydney. Here, Jim Pickett re-emphasizes the importance of adherence in clinical trials (a big topic of discussion at the conference) and his optimism about the future of the HIV prevention and treatment landscape. Read Part I here.

MP: Can you give us some examples that illustrate the issues surrounding adherence?

JP: The Partners PrEP trial and the FEM-PrEP trial are good case studies to illustrate the issues surrounding adherence in an HIV prevention clinical trial. Partners PrEP reported very high levels of adherence while the FEM-PrEP trial had to be stopped in April 2011 due to “futility.” Studies later indicated that while many of the FEM-PrEP participants said they adhered to the medication schedule, blood tests indicated that many did not.

A built-in support system and the risk perception of participants are the key here. In Partners PrEP, serodiscordant couples were enrolled together into the trial. One partner was HIV positive while the other was negative. The HIV risk of the HIV-negative partner was not theoretical; it was real. HIV was in their life and they were in it together.

FEM-PrEP involved women recruited on their own, with no consideration whether they were in a serodiscordant relationship – or any relationship for that matter. The risk of HIV was not present in the form of a partner who already had it, but it was, in fact, present in their environment where there was very high HIV incidenceIV HIV . It is interesting that many of these women did not believe themselves to be at a high risk of HIV, despite this high incidence.

Human beings are very good at rationalizing risks and saying “it can never happen to us.” I can drive fast and will never get into a car accident. If I feel a certain behavior is not risky, or that I can “get away with it”, I will not take steps to protect myself.

We don’t want to create tools where only people who are married or in a relationship are able to use the tools successfully. That would be crazy. But we do have to think about how important those social relationships are and use the lessons learned to devise new tools and new trials that give us answers – and develop things that work for all kinds of people, regardless of relationship status, sexual orientation, or whether their potential HIV exposure comes from unprotected vaginal intercourse, unprotected anal intercourse, or from the sharing of syringes during injection drug use.

MP: Are there any trials coming up that you are excited about?

JP: I’m very excited by the upcoming MTN-017 rectal microbicide safety and acceptability trial that will enroll approximately 186 gay men, other men who have sex with men, and transgender women at trial sites in South Africa, Peru, Thailand, and the United States. Participants will go through three eight-week cycles: One cycle of having a daily Truvada tablet, another cycle of applying a “rectal friendly” reformulated tenofovir gel every day, and a cycle of applying the gel before and after having sex.

What impresses me is the level of community involvement sought and obtained to help design this trial. The trial team, and advocates such as myself, visited each of the sites mentioned, had day-long meetings with community members, captured all their observations, and made adjustments to the trial design from the input received. We have to listen to the voices of the communities. We can’t just show up and conduct trials.

MP: What are your other thoughts on the HIV prevention and treatment landscape?

JP: I always like to compare the HIV prevention and treatment landscape to the evolution of computers and phones. Years ago, computers were the size of a house. It took time for the computer to evolve from its clunky beginnings to its current look where we can carry it around in our pocket and it can do more things than we ever could have imagined. Now we have phones and computers that are completely intuitive and easy to use.

Similarly, the HIV landscape has evolved over the years. Before 1996, we had a handful of drugs that didn’t always work great. They were toxic and had to be taken multiple times a day. When protease inhibitors came out in 1996, people near death’s door were brought back to life. But they also had to suffer through a whole host of side effects like nausea, diarrhea, and body disfigurements.

Now, new-age ARV medication can combine three drugs into one pill that has to be taken just once a day. The side effects are minimal and you don’t have to worry about requirements like eating it on a full or empty stomach, or having it refrigerated.

We are now in the clunky computer stage of ARV-based prevention. But, things will keep getting better. We can’t get to the streamlined phase before going through the clunky phase. We have to learn to crawl before we can run. Someday, our ARV prevention tools will be as sexy as the iPhone.

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team. Read Part I of Jim’s interview here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Researchers Report Low Number of People Living with HIV That Adhere to HIV Treatment and Care

via AIDSmeds.com, by Tim Horn

Only one in five people living with HIV meet the criteria for being established and retained in care, according to a new analysis involving 12 clinics across the United States to be published in a forthcoming issue of the Journal of Acquired Immune Deficiency Syndromes. Though the authors warn that the data involving nearly 23,000 people enrolled in the HIV Research Network are not representative of retention rates in the country, the results nevertheless underscore a need for improvements in keeping those living with the virus connected to care.

As John Fleishman, PhD, of the Agency for Healthcare Research and Quality in Rockville, MD, and his colleagues write: HIV care is a continuum. One end reflects the estimated 1.2 million people believed to be living with HIV in the United States; the opposite end reflects the low rate (28 percent) of people living with HIV in the country who are successfully engaged in HIV care, receiving antiretroviral therapy and maintaining undetectable viral loads.

Provision of care is problematic at intermediate points in this continuum. “An estimated 21 percent of persons living with HIV in the U.S. are unaware of their infection,” the authors note. “Among those aware of their HIV infection, initial linkage to care is often delayed. After patients have been linked with a provider and have made an initial visit, they must still remain in care, with regular visits over a long time period.”

The study conducted by Fleishman’s group examined these later, but essential, stages in the HIV care continuum, notably rates of establishment and retention in care. These rates were determined using three main measurements.

“Establishment” applied to patients who made follow-up visits for longer than six months after showing up once for HIV care. “Retention” applied to patients who had been seen at least twice at HIV Research Network clinics, with visits separated by 90 days, in each year following their initial visit. The researchers also considered the rate of patients lost to follow-up—those who stopped their HIV Research Network clinic visits without notifications.

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]