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.

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

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.

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

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.


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

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.

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

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.

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