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.]

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.]