Antiretroviral Prophylaxis for HIV Prevention Reaches a Key Milestone

via 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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*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
 
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An Interview with Professor Salim Abdool Karim about VOICE Trial Setbacks

viaAllAfrica, interview with Professor Salim Abdool Karim

Professor Salim Abdool Karim, director of the Centre for the AIDS Program of Research in South Africa (Caprisa) at the University of KwaZulu-Natal and Columbia University in the United States, spoke to AllAfrica's Julie Frederikse about the unexpected halt of a study into tenofovir vaginal gel. This followed a finding that the microbicide failed to prevent HIV transmission, in contrast to the positive result in a previous study conducted by his Caprisa team.

What happened when you heard the findings of the new study that contradicted your results?

We were surprised and very disappointed. We know that science doesn't always give you the answers you want and hope for, but when you look at the totality of the evidence, we know that there's still pretty strong evidence, whether from the laboratory or in monkeys or in humans, that tenofovir gel is effective in preventing HIV. This is rationale for why the Caprisa and Voice (Vaginal and Oral Interventions to Control the Epidemic) studies were conducted in the first instance. So now we need to understand why the Voice trial produced a different result.

Is this a big setback to Caprisa's research?

The Voice trial is an important result. We now need to understand it. It doesn't take us completely off track - it's a temporary setback - and understanding this result would put us in a better position to move forward again. Science grows not only from success, it also grows from failure.

Has the suspension of this study demoralised your team?

That's the nature of science. In a series of studies, it is seldom that every study shows the same thing. But we'll stay on track, and try and understand why the Voice result is different. Whether the women in the study were not using the gel correctly, or there were other underlying problems, we don't know yet. It's too early to tell.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

No time to give up on microbicides

via allAfrica.com, by Julie Frederikse

Africans tracking the worldwide HIV epidemic have not found much to celebrate since Aids began ravaging the continent 30 years ago, but researchers are optimistic that they are learning as much from their failures as their successes.

Sub-Saharan Africa still carries the biggest burden of HIV worldwide, and while there has been a significant improvement in access to antiretroviral treatment in recent years, scientists searching for a gel or vaccine that can prevent HIV infection ride a rollercoaster of hope and disappointment.

Take the case of a husband and wife team from the University of KwaZulu-Natal in South Africa. Professors Salim Karim and Quarraisha Abdool Karim head up a research unit that has been at the forefront of clinical trials to find a safe and effective microbicide to protect women from HIV.

In July 2010, delegates at the last World Aids conference gave the couple a standing ovation when they announced the results of one of the most promising studies on HIV prevention to date. Their team at the Centre for the Aids Program of Research in South Africa (Caprisa), showed that a vaginal gel called tenofovir was able to reduce sexual transmission of the virus by 39 percent overall and 54 percent in women who used it consistently.
But the euphoria over this breakthrough has dissolved into disappointment, with the unexpected finding of a wider sub-Saharan African study that the microbicidal gel, when prescribed daily, does not prevent HIV infections. This has led to the suspension of tenofovir in the Vaginal and Oral Interventions to Control the Epidemic (Voice) trial.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

The Future Role of Rectal and Vaginal Microbicides in Heterosexual Couples

via STI British Medical Journal, by Marie-Claude Boily, Dobromir Dimitrov, Salim S Abdool Karim, Benoît Mâsse

Objectives

To compare the potential impact of rectal (RMB), vaginal (VMB) and bi-compartment (RVMB) (applied vaginally and protective during vaginal and anal intercourse) microbicides to prevent HIV in various heterosexual populations. To understand when a RMB is as useful than a VMB for women practicing anal intercourse (AI).

Methods

Mathematical model was used to assess the population-level impact (cumulative fraction of new HIV infections prevented (CFP)) of the three different microbicides in various intervention scenarios and prevalence settings. We derived the break-even RMB efficacy required to reduce a female's cumulative risk of HIV infection by the same amount than a VMB.

Results

Under optimistic coverage (fast roll-out, 100% uptake), a 50% efficacious VMB used in 75% of sex acts in population without AI may prevent ~33% (27, 42%) new total (men and women combined) HIV infections over 25 years. The 25-year CFP reduces to ~25% (20, 32%) and 17% (13, 23%) if uptake decreases to 75% and 50%, respectively. Similar loss of impact (by 25%–50%) is observed if the same VMB is introduced in populations with 5%–10% AI and for RRRAI=4–20. A RMB is as useful as a VMB (ie, break-even) in populations with 5% AI if RRRAI=20 and in populations with 15%–20% AI if RRRAI=4, independently of adherence as long as it is the same with both products. The 10-year CFP with a RVMB is twofold larger than for a VMB or RMB when AI=10% and RRRAI=10.

Conclusions

Even low AI frequency can compromise the impact of VMB interventions. RMB and RVMB will be important prevention tools for heterosexual populations.

Read the full study here.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

ARV gel almost ready to roll out

via the Daily News, by Liz Clarke

In the time it takes parents to see their children grow from birth to adulthood, the vaginal gel containing the antiretroviral tenofovir has been under close and intense scrutiny.

Now nobody is more keen to see the fast-track roll-out of the life-saving microbicide than Professor Quarraisha Abdool Karim.

Research initiated 20 years ago at the Medical Research Council and in the past ten years at Caprisa finally culminated in a definitive proof that a microbicide, namely tenofovir gel, reduces the risk of women contracting HIV.

“Twenty years might sound a long time,” she said this week, “but this sort of science requires painstaking input from every member of the research team. We have had to ensure that every avenue – from concept to proof – has been covered. Now that we can prove that tenofovir gel works, we are looking forward to implementing the next step.”

That next step, awaiting approval from the Medicines Control Council, will test the feasibility of integrating tenofovir gel provision into family planning services.

As a principal researcher in the Caprisa 004 scientific research programme, Abdool Karim demonstrated that the gel prevented both HIV and Herpes Simplex Virus (HSV) Type 2 infection.

It’s a finding that has been lauded as one of the most significant scientific breakthroughs in the fight against Aids by WHO, UNaids and several leading organisations

“But there is no time to rest on these laurels,” she says. “There is much work still to do.”

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

IRMA's next teleconference: Yes, Africa Needs Rectal Microbicides - 9/27

Yes, Africa Needs Rectal Microbicides
Tuesday, September 27, 2011, 10:00 EDT

(click here to determine the time in your area)

Please join IRMA and AVAC with our special guest Dr. Salim Abdool Karim (Slim.)

Slim is a clinical infectious diseases epidemiologist whose main current research interests are in microbicides and vaccines to prevent HIV infection and implementing antiretroviral therapy in resource constrained settings. He is Pro Vice- Chancellor (Research) at the University of KwaZulu-Natal in Durban, South Africa and is also Professor of Clinical Epidemiology at the Mailman School of Public Health at Columbia University and Adjunct Professor of Medicine at the Weill Medical College of Cornell University. He is Director of CAPRISA - Centre for the AIDS Programme of Research in South Africa.

Slim did a fantastic presentation at the Microbicides 2010 called "Does Africa Need a Rectal Microbicide" and the data he shared revealed the answer to be a resounding "YES!" He will be doing an updated version of this presentation on our call.

Additionally, IRMA's Jim Pickett will discuss Project ARM - Africa for Rectal Microbicides. Project ARM is hosting a 2-day strategy meeting at the ICASA 2011 conference in Ethiopia this December. The 40 invited participants and speakers will be working on crafting an African-specific agenda for rectal microbicide advocacy and research that ensures Africa remains on the rectal microbicide map, and that all Africans who need rectal microbicides have access to them when they become available.

Click here to RSVP. Check back here in advance of the call for presentation slides. An audio recording of the call will be made available shortly after its completion.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Does Africa Need a Rectal Microbicide? The answer - YES!

A rectal microbicide as a new HIV prevention technology is urgently needed in Africa for the large number of people practicing anal sex.

Current HIV prevention efforts are unable to contain or reduce the spread of HIV infection through anal sex.

One of the highlights of Microbicides 2010 was the presentation Does Africa need a rectal microbicide?  by Salim S. Abdool Karim (Slim), Pro Vice-Chancellor (Research): University of KwaZulu-Natal, Director: CAPRISA, Professor in Clinical Epidemiology, Columbia University and Adjunct Professor of Medicine, Cornell University.

The information Slim presented painted a deadly serious picture of neglect, denial, and criminalization with regard to the prevalence of anal sex among both men and women, as well as the near invisibility of gay men and other men who have sex with men in Africa despite harrowing rates of HIV. However, it was heartening and inspiring to have some serious. long-awaited attention paid to these issues - made all the better coming from one of the world's top researchers in the field.

Click here for his slides.


What follows is an excellent summary of the presentation by Henry Neondo via African Science News

Africa ripe for rectal microbicides

Africa needs microbicides for both vaginal and rectal use in prevention of mucosal infection of HIV, a mini-symposium at the ongoing International Microbicides Conference in Pittsburgh, Pennsylvania, US was told. The symposium heard that the contribution to HIV flame in Africa by the anal route is still under-reported and that time to unpack the myth was long overdue.

According to Dr Salim S. Abdool Karim, Pro Vice-Chancellor (Research), Univesity of KwaZulu Natal and Director of the Center for the AIDS Programme of Research in South Africa, CAPRISA, Africa needs to take a leap from the assumptions that HIV is spread only through the penile route.

“But a rectal microbicide as a new HIV prevention technology is urgently needed in Africa for the large number of people practicing anal sex---namely the men who have sex with men, bisexual men and women”, he said.

Dr Karim said although data on anal sex is as rare as data on the true situation of HIV in men who have sex with men throughout Africa, anonymous surveys in various parts of Africa show interesting pictures.

In Cape Town, South Africa, a survey of 2593 men and 1818 women showed that 14% of men and 10% of women had anal intercourse in the past three months.

In KwaZulu Natal, South Africa, 40.8% of the surveyed reported practicing anal intercourse. Worse, 30% of these reported never or rarely using condom during an intercourse.

Dr Karim said consistent use of condom in anal sex was lower that peno-vaginal intercourse.

The same scenario is reflected in Kenya and Nigeria, which report that 12% of public secondary schools students practice anal sex.

In all these countries, people who do not have knowledge of any HIV infected persons, a poor knowledge of increased HIV risks and distant HIV test often tended to have unprotected anal intercourse.

Recent studies on MSM sex workers indicate widespread existence of MSM groups in Africa. The study showed at least 739 MSM sex workers in Mombasa, Kenya and 496 in Johannesburg, South Africa. Further, it is reported that HIV prevalence among MSMS in Egypt is 6.2% and 14% in South Africa, 21%  in Senegal and 33% in Zambia.

But no one can tell of the true picture. The situation, said Dr Karim is not helped by the whole challenges surrounding men who have sex with men in Africa.

Through out Africa, MSM and their needs are largely ignored in HIV prevention and treatment efforts.

“Current HIV prevention efforts are unable to contain or reduce the spread of HIV infection through anal sex”, he said.

This is largely enforced by partly legislation, socio-cultures and out right infringement on human rights.

He said same sex relations are criminalized in 37 out of 54 African countries and are punishable by death in four of these.

For example in countries such as Malawi, where 21.4% men who have sex with men live with the virus that causes AIDS, a court jailed two men for 14 years for what it termed gross indecency and unnatural acts.

In Uganda, a Bill is still pending in the Parliament that could provide for a death sentence for anyone practicing homosexuality.

Most AIDS prevention messages are targeted at the heterosexual men and women emphasizing the risks of transmission through peno-vaginal sex and not through anal intercourse.

Dr Karim said the needs of the many women who are unable to get men to use condoms in anal sex are ignored.