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PrEP Media Round-Up - It Works for Heterosexuals Too!

[UPDATED JULY 18]

The exciting news was announced last week that pre-exposure prophylaxis has been shown to work for heterosexual men and women as well as MSM. This is HUGE for HIV prevention.

Below is a selection of news items and press releases we have collected on the two studies that reported out last week. In the comments feel free to share your reactions to this news.

Washington Post: Two studies show that drugs used to treat AIDS can be used to prevent HIV infection, too

EurekAlert (Microbicide Trials Network): VOICE study will continue as it considers what action to take after results of 2 trials

CDC: CDC Trial and Another Major Study Find PrEP Can Reduce Risk of HIV Infection among Heterosexuals

iPrEX News: Two Major Studies Prove HIV Pre-Exposure Prophylaxis (PrEP) Works in Heterosexual Women and Men; Build on iPrEx Data Showing PrEP Reduces HIV Infections in Men Who Have Sex with Men

Wall Street Journal: AIDS Drugs Can Prevent Infection, Studies Show

AIDSMAP: Two major studies show that HIV drugs prevent infection

New Vision: Drugs prevent HIV infection up to 73%

Science Now: Anti-HIV Pills Show Powerful Effect Against AIDS

Reuters: 2-Once-daily AIDS pill can slash HIV infection risk

POZ: PrEP Reduces HIV Risk in Two Major Studies

PlusNews: HIV/AIDS: More proof that PrEP works

New Scientist: One cheap pill protects healthy people from HIV

The Daily Nation: Daily dose of drug ‘lowers risk of HIV infection’

Fit Perez: New Pill Could Prevent HIV

Project Inform: Project Inform urges government action following the positive results of two PrEP studies in heterosexual men and women

[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.]

Two studies show that drugs used to treat AIDS can be used to prevent HIV infection, too

[THIS IS HUGE!]

via Washington Post, by David Brown

Two new studies done in three African countries have shown for the first time that AIDS drugs taken daily can cut by more than half a person’s chance of becoming infected with HIV through heterosexual intercourse.


The results, announced early Wednesday, provide more evidence that the drugs responsible for saving the lives of millions of HIV-infected people over the last 15 years may also be the most useful tool for preventing new infections.

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.]

NEWS ROUNDUP: Early HIV Treatment Can Reduce Transmission Risk By 96%, Study Results Show

via Kaiser Family Foundation


Results from a multicountry clinical trial, sponsored by the National Institute for Allergy and Infectious Diseases (NIAID), show that HIV-positive people who take combination antiretroviral therapy (ART) can reduce the risk of transmitting the virus to their HIV-negative partners by 96 percent, U.S. researchers announced on Thursday "[i]n what is being hailed as a breakthrough in HIV prevention," the Los Angeles Times reports (Maugh, 5/13).

The randomized controlled trial, run by the HIV Prevention Trials Network and named HPTN 052, was meant to run another four years, but an interim analysis by an independent monitoring group prompted NIAID to halt the trial and release the results, ScienceInsider writes. The study, conducted since 2005 at 13 sites in nine countries, recruited 1,763 couples, 97 percent of whom were heterosexual, in which one partner was HIV-positive at enrollment. None of the HIV-positive partners had taken ART, and their CD4 cell counts, a measure of the immune system's health, were between 350 to 550. "Half the participants received immediate treatment, and the other half did not start [therapy] until their CD4 count dropped to 250 or they developed an AIDS-related symptom, according to ScienceInsider (Cohen, 5/12).

Analysis "identified 39 new cases of HIV among the previously uninfected partners. In 28 of these cases, genetic analysis confirmed that one partner had infected the other. Of these 28 infections, 27 – or 96 percent – occurred among couples in which the HIV-infected partner did not start antiretroviral therapy immediately," HealthDay/U.S. News reports (Reinberg, 5/12). The couples were all counseled on safe sex practices, given free condoms and provided treatment for sexually transmitted infections, BBC News adds (Gallagher, 5/12).

"This new finding convincingly demonstrates that treating the infected individual – and doing so sooner rather than later – can have a major impact on reducing HIV transmission," NIAID Director Anthony Fauci said in a statement (5/12).

The New York Times notes that though the trial was "relatively large," there are limitations to interpreting the results for other populations, like men who have sex with men, because nearly all "of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual" (McNeil, 5/12).

Treating HIV-positive participants early also improved other health outcomes, the Los Angeles Times reports, noting that the results showed 17 cases of disseminated tuberculosis (TB) among those whose treatment was deferred compared with three cases among the treatment group (5/13). According to Bloomberg News, researchers will continue to monitor study participants to determine whether treatment benefits persist (Cortez/Bennett, 5/13).

Treatment As Prevention

"Until now, antiretroviral therapy was known to improve the health of people infected with human immunodeficiency virus, but this is the first study to show a solid impact on preventing transmission to an HIV-negative partner," Agence France-Presse reports (Sheridan, 5/12).

Though the preliminary results "are likely to end, or at least diminish, a bitter feud within the AIDS world over how much funding should go to treatment versus prevention," funding "will be a major obstacle," the Wall Street Journal writes. With more than five million HIV-positive people on treatment at the end of 2009, and another 10 million in need of the drugs based on international treatment guidelines, UNAIDS has estimated a treatment funding shortfall of more than $7.5 billion, the Wall Street Journal notes (Schoofs/McKay, 5/12).

Observational studies have shown a benefit to early HIV treatment, leading UNAIDS last year to adopt "as its goal" a "test and treat" policy that "encourages doctors to start people on treatment as soon as they test positive for HIV," the New York Times states. Still, "[f]or lack of money, clinics in Africa are turning away patients who are not just infected but close to death. And in some American states where money provided by the Ryan White Care Act has run out, poor uninsured people are on waiting lists," the newspaper adds (5/12).

UNAIDS Executive Director Michel Sidibe said, "This breakthrough is a serious game changer and will drive the prevention revolution forward. It makes HIV treatment a new priority prevention option," adding, "Now we need to make sure that couples have the option to choose treatment for prevention and have access to it," according to Reuters (Steenhuysen, 5/12). Sidibe said "he hopes the new results will compel pharmaceutical companies to lower the price of ARVs as the demand for the drugs expands," that "new partnerships will form to advocate for increased funding and that the findings will be prominently discussed next month at the United Nations High Level Meeting on AIDS in New York City," ScienceInsider reports (5/12).


[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.]

Amount of HIV in Genital Fluid Linked to Transmission

Via Health News, by Randy Dotinga

In a development that could enhance HIV-prevention research, a new study of heterosexual couples confirms that the risk of transmitting HIV rises with the level of the virus in semen and cervical fluid.

The finding, that more virus translates to higher likelihood of transmission, hasn't been proven to this extent before, said study lead author Dr. Jared M. Baeten of the University of Washington in Seattle.

"This confirms what we had thought about the biology of HIV," he said, "and it gives us new information about genital levels of HIV being particularly important, even independent of blood levels."

For the study, researchers obtained samples of genital fluid from 2,521 heterosexual couples living in seven African countries. Most were married and living together. At the start of the two-year study, one partner in each couple was infected with HIV, the AIDS-causing virus, and none was taking anti-HIV drugs.

Over the course of the study, published April 6 in the journal Science Translational Medicine, 78 partners became infected within the relationship.

The researchers compared cervical and semen fluid samples from partners who transmitted the virus with samples from men and women who didn't transmit the virus and found that the risk of HIV transmission approximately doubled with each specified HIV increase in genital fluids.

This can help researchers better understand "the natural protections that the penis, the vagina and the rectum have that we want to make sure we preserve," he said. The study "is highlighting what we need to look at going forward," he added.

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.]

Bringing Up The Rear



Via salon.com, by Tracy Clark-Flory

It's no secret that more Americans are having anal sex than ever before: A study published last year in the Journal of Sexual Medicine found that more than 45 percent of women in their late 20s had tried anal sex.

On the flip side, women rarely get the opportunity to be penetrators. Virginia Vitzthum exquisitely described the appeal of taking on the male role in a piece for Salon back in 1999 -- before we even called it "pegging"
"In a way I'd never understood those words before, he was mine. The knowledge I could really hurt this person by being less than careful made me feel responsible, protective. The vulnerability appalled me at the same time; it was vaguely disgusting that he would let someone do this to him. Mixed in with the disgust was possessiveness. The thought of anyone else penetrating him seemed revolting. These observations clicked into place in quick succession; I felt like a projector being loaded with slides of maleness, of male seeing."
But, taboos change, and so do the cultural meanings of particular sexual acts. Just as the gay community has long debated the politics of being a top or a bottom, the hetero world is slowly catching up -or, um, bringing up the rear. As Pulley puts it, "We only have so many orifices. You'd think we'd all be itching to take advantage of them all, right?"

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.]

Is Africa ready for PrEP?

Via Incidence0.org, by Adebisi Ademola Alimi

One of the biggest breakthrough in HIV clinical research, since the outbreak of the epidemic 30 years ago, is the recent success in a clinical trial of a new HIV prevention approach based on the daily use of the antiretroviral drug Truvada by HIV negative person to prevent HIV transmission (Called PrEP, for Pre-Exposure Prophylaxis).

The results of the iPrEX trial raised hope but also many questions and concerns as showed by the ensuing debate about what the next step should be. Divergences culminated with the Aids Health Foundation (AHF) petitioning the FDA not to consider Gilead’s request for a licence to use Truvada for the prevention of HIV infection and a joint counter response by a number of HIV advocacy organisations.

But for me as an advocate and an African living in Europe, the most important thing on my mind is “Will Africa be able to access PrEP?” Providing ARV to HIV negative people in Africa needs to be considered in light of the challenge of accessing treatment in Africa, where more than 50% of HIV positive people in the world live (UNAIDS report).

Even if PrEP drugs become available, what are the mechanisms in place to ensure that it will not be tribalized in a continent where there are some indications that access to ARVs is based on political and ethnical loyalty and where there are evidences of bribery at the delivery point, misused of funds and a non-negligible ARVs black market leading to ARVs being dispensed to increasing numbers of patients at the periphery of the health system. One has to be skeptical about the PrEP implementation process in this context.

Read the full article

[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.]

CROI 2011: Rectal Microbicides to Prevent HIV Infection in Heterosexual Populations in High-prevalence Settings

Poster from CROI 2011

Dobromir Dimitrov*1, M-C Boily2, S Abdool Karim3, and B Mâsse1,4
Fred Hutchinson Cancer Res Ctr, Seattle, WA, US; 2Imperial Coll London, UK; 3Univ of KwaZulu-Natal, Durban, South Africa; and 4Univ of Montreal, Canada


Background:
The role of anal intercourse in the overall heterosexual HIV epidemic remains unclear. However, it may be an important risk factor because the considerably higher risk of HIV infection during unprotected receptive anal intercourse compared to vaginal intercourse. Anal intercourse is widely practiced by heterosexuals in many countries; in Tanzania, 6% of sexually active school pupils reported anal intercourse at their first sexual experience. In Cape Town, 10 to 14% of the study participants reported engaging in anal intercourse over the last 3 months. Different mathematical modeling studies have assessed the potential impact of a vaginal microbicide in heterosexual populations and of a rectal microbicide for homosexuals. However, none have assessed the potential impact of a rectal microbicide in heterosexual population. Our study aims to compare the potential impact of rectal, vaginal, and bi-compartment (i.e. applied vaginally and protective during vaginal and anal intercourse) microbicides to prevent HIV acquisition and transmission in heterosexual populations.

Methods:
Risk equations were used to determine under which conditions a rectal microbicide could be as useful as a vaginal microbicide. A transmission dynamic model was used to assess the population-level impact of the different microbicides in a variety of intervention scenarios and high HIV prevalence settings and to predict the fractions of new HIV infections prevented over fixed time periods.

Results:
Without anal intercourse, a 50% efficacious vaginal microbicide used by 100% of females prevents about 10% and 25% of all new male and female HIV infections over 10 years if adherence is 30% and 75%, respectively. These 10-year infection preventions are reduced by 32% in populations with 10% frequency of receptive anal intercourse, assuming 4-fold increase in transmission risk per receptive anal intercourse (RRRAI). A rectal microbicide could be as effective as a vaginal microbicide in populations with anal intercourse rates ranging from 5% to 20% across a range on RRRAI, assuming similar efficacy and frequency of use of both products. A rectal microbicide has less impact than a vaginal microbicide in populations with <5% anal intercourse, unless it is used more often or is more efficacious than a vaginal microbicide. The 10-year infections prevented of bi-compartment microbicide is 2-fold larger than vaginal microbicide in populations with 10% anal intercourse if RRRAI = 10- and ~6-fold larger than rectal microbicide, in populations with 5% anal intercourse if RRRAI = 4.

Conclusions:
Both rectal microbicide and bi-compartmental microbicide are necessary prevention tools for heterosexual populations engaging, relatively frequently (~10% of sex acts), in anal intercourse.


[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.]

HIV Transmission Risk Through Anal Intercourse: systematic review, meta-analysis and

Via International Journal of Epidemiology by Rebecca F Baggaley, Richard G White, and Marie-Claude Boily

Background
The human immunodeficiency virus (HIV) infectiousness of anal intercourse (AI) has not been systematically reviewed, despite its role driving HIV epidemics among men who have sex with men (MSM) and its potential contribution to heterosexual spread. We assessed the per-act and per-partner HIV transmission risk from AI exposure for heterosexuals and MSM and its implications for HIV prevention.

Methods
Systematic review and meta-analysis of the literature on HIV-1 infectiousness through AI was conducted. PubMed was searched to September 2008. A binomial model explored the individual risk of HIV infection with and without highly active antiretroviral therapy (HAART).

Results
A total of 62 643 titles were searched; four publications reporting per-act and 12 reporting per-partner transmission estimates were included. Overall, random effects model summary estimates were 1.4% [95% confidence interval (CI) 0.2–2.5)] and 40.4% (95% CI 6.0–74.9) for per-act and per-partner unprotected receptive AI (URAI), respectively. There was no significant difference between per-act risks of URAI for heterosexuals and MSM. Per-partner unprotected insertive AI (UIAI) and combined URAI–UIAI risk were 21.7% (95% CI 0.2–43.3) and 39.9% (95% CI 22.5–57.4), respectively, with no available per-act estimates. Per-partner combined URAI–UIAI summary estimates, which adjusted for additional exposures other than AI with a ‘main’ partner [7.9% (95% CI 1.2–14.5)], were lower than crude (unadjusted) estimates [48.1% (95% CI 35.3–60.8)]. Our modelling demonstrated that it would require unreasonably low numbers of AI HIV exposures per partnership to reconcile the summary per-act and per-partner estimates, suggesting considerable variability in AI infectiousness between and within partnerships over time. AI may substantially increase HIV transmission risk even if the infected partner is receiving HAART; however, predictions are highly sensitive to infectiousness assumptions based on viral load.

Conclusions
Unprotected AI is a high-risk practice for HIV transmission, probably with substantial variation in infectiousness. The significant heterogeneity between infectiousness estimates means that pooled AI HIV transmission probabilities should be used with caution. Recent reported rises in AI among heterosexuals suggest a greater understanding of the role AI plays in heterosexual sex lives may be increasingly important for HIV prevention.

For the full study click here.