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Archive for the ‘Prevention’ Category

Exciting research suggests that a shot every one to three months may someday give an alternative to the daily pills that some people take now to cut their risk of getting HIV.

The experimental drug has only been tested for prevention in monkeys, but it completely protected them from infection in two studies reported at an AIDS conference on Tuesday.

“This is the most exciting innovation in the field of HIV prevention that I’ve heard recently,” said Dr. Robert Grant, an AIDS expert at the Gladstone Institutes, a foundation affiliated with the University of California, San Francisco.

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HIV Disclosure Laws

A study led by the Medical College of Wisconsin (MCW) and published online today in the American Journal of Public Health found that a New Jersey law requiring individuals with HIV to disclose their HIV-positive status to their sexual partners does not appear to be an effective HIV prevention intervention.

Fifty-one percent of study participants were aware that New Jersey had such a law. However, persons who were aware of the law were just as likely as persons who were unaware of the law to disclose their HIV status, engage in less risky sexual behaviors (such as fewer number of partners), and use condoms.
The majority of participants, regardless of being aware or unaware of the law, reported having been in compliance with the law for the previous year – that is, they abstained from sex or they informed their prospective partners of their HIV-positive status.In fact, 85 percent of participants reported that they would not be willing to engage in unprotected sex with an HIV-negative partner who was not informed of their HIV-positive status.

Awareness of the law was not associated with negative outcomes for HIV-positive study participants. Participants who were aware of the law did not perceive greater social hostility toward persons living with HIV, or experience more discomfort with HIV status disclosure or more HIV-related stigma. Conversely, those who were unaware of the law perceived more social hostility toward persons living with HIV, experienced greater HIV-related stigma and were less comfortable with HIV status disclosure.

Principal Investigator Carol Galletly, JD, PhD, of the Center for AIDS Intervention Research (CAIR) at MCW, and her colleagues surveyed a sample of 479 people in New Jersey who are HIV-positive between March 22, 2010 and October 6, 2010. Participants varied by sex and race: 45 percent of were female, two-thirds were African-American, 16 percent were Hispanic, and 13 percent were Caucasian. The study population ranged from ages 19 to 66. Galletly is an associate professor of psychiatry and behavioral medicine at MCW.

The article, “New Jersey’s HIV exposure law and the HIV-related attitudes, beliefs, and sexual and seropositive status disclosure behaviors of a sample of persons living with HIV,” was written by Galletly, along withLaura R. Glasman, PhD, Steven D. Pinkerton, PhD, and Wayne DiFranceisco, MA, all of CAIR.

A majority of U.S. states have enacted laws that regulate the sexual behavior of people living with HIV. Most of these laws require individuals with HIV to disclose their HIV status to prospective sex partners. In New Jersey, violation of the law is a felony. This designation is typical, and some states even require individuals who have violated these laws to register as sex offenders. Wisconsin does not have a criminal HIV exposure law; however, Wisconsin code allows for enhanced penalties for persons who commit certain serious sexual crimes while knowing that they are HIV-positive.

Galletly and her colleagues also asked participants about responsibility for HIV prevention. 90% believed that a person living with HIV bears at least half the responsibility for insuring that an HIV-negative partner doesn’t contract HIV through sex. 34% thought the HIV-positive person has full responsibility.

While these results are specific to New Jersey, several states have enacted similar versions of this law. Researchers are working to compare findings from different states.

Galletly’s research was funded by Public Health Law Research, a national program of the Robert Wood Johnson Foundation, as well as a grant from the National Institute of Mental Health.

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High Viral Loads Linked to HIV Risk Among Black MSM

The high HIV incidence among black men who have sex with men (MSM) in the United States may be explained, at least in part, by the finding that HIV-negative black MSM, compared with white MSM, are more than twice as likely to encounter a sex partner who can transmit HIV if safer sex practices are not followed.

The incidence and prevalence of HIV among black MSM, particularly young black MSM, continue to be disproportionately high compared with those among MSM of other races or ethnicities. Yet in studies, black MSM consistently report the same or lower levels of sexual- or drug-using risk behaviors as other MSM.

The researchers created a tool—transmission potential prevalence, or TPP—to calculate how many black and white MSM participating in the study were both HIV positive and had viral loads high enough to pass it on to others.

HIV prevalence was 42 percent in the black group compared with 14 percent among the white MSM.

Incidence (new HIV cases) in the study was found to be 6.4 cases per 100 person-years among those in the black MSM group, compared with 1 case per 100 person-years in the white MSM group. “In other words, if we had 100 HIV-negative black MSM, one year later we would see six cases develop, while among 100 white [MSM] we would see one case develop over the course of a year.”

By expanding the parameters to include everyone—undiagnosed as well as diagnosed—the researchers found 25 percent of the black MSM were both HIV positive and had viral loads above 400, as compared with 8 percent among the white participants.

Translating these data into the probability of encountering a sex partner who is capable of transmitting HIV, the study found that black MSM faced a 39 percent chance that at least one partner has transmission potential, compared to 18 percent among white men at the same risk behavior level.
Rosenberg explained what this means: “To have a 50 percent chance of acquiring HIV, a black MSM needs just three partners, compared to seven for white MSM. To reach a 90 percent risk of HIV, a black man would need 10 partners, compared to 25 for white MSM.”

The researchers conclude that HIV prevention approaches that rely solely on changing risk behavior will not work to eliminate racial disparities.

They recommend that new resources aimed at preventing transmission be focused on communities with a high TPP, and that viral load measurements be incorporated into HIV surveillance measures in a manner that accounts for TPP.

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Turning the Tide of HIV for MSM, Sex Workers and Trans People

AIDS 2012There has been much optimistic talk this past year about turning the  tide of HIV and creating an AIDS-free generation. For this to translate  to reality, we must address the high HIV prevalence rate among the most  vulnerable populations: men who have sex with men (MSM), sex workers and  transgender people. In addition, antiretrovirals—heralded as treatment  and prevention—must be made available to millions more HIV-positive  people. Is any of this possible in the real world, and if so—how do we  do it? Four speakers addressed these topics in a plenary session titled  “Dynamics of the Epidemic in Context” on Thursday, July 26, at the XIX  International AIDS Conference (AIDS 2012) in Washington, DC.

MSM and HIV “Men who have sex with men exist everywhere—I also am a man who has sex  with men.” With this declaration, Paul Semugoma, MD, a practicing  physician in Kampala, Uganda, opened his plenary discussion. Such a  declaration was necessary and “mega important,” he said, because of the  level of ignorance and denial across the globe concerning MSM.
Many countries that report HIV data fail to collect any information on  MSM, as if these men don’t exist, he said. Yet the fact is that across  the globe HIV prevalence among MSM is higher than other adults. The  disparities are alarmingly stark among black MSM. African-American MSM  are 72 times more likely to be HIV positive than the general U.S.  population; in Canada, black MSM are 73 times more likely to be  positive; and in the United Kingdom, they are 111 times more likely to  be living with the virus. The disparities continue across the HIV health  spectrum—MSM are more likely to be undiagnosed and uninsured, to have a  harder time attaining and staying on meds, and they’re less likely to  suppress the virus. “An AIDS-free generation?” Semugoma asked, in  reference to a popular slogan, “Not without including MSM.”

We know that condoms, PrEP (pre-exposure prophylaxis), treatment as  prevention, behavior changes and other interventions work, Semugoma  said, so the question is how to apply them to the MSM population.

What are the main challenges in doing so? Criminalization of same-sex  practices. Semugoma used Senegal and Uganda to illustrate this problem.  Both countries have an HIV epidemic concentrated among MSM, but when  health workers and advocates tried to reach these men, they were  arrested and prosecuted for promoting homosexuality and gay rights. The  fear, he noted, is that homosexuality will spread throughout the  population, and the reality is that HIV is what is spreading.

What about solutions? Semugoma’s call to action is to end the  invisibility of MSM, to include them in health care delivery, in  epidemiology and decision-making. And to return to basics: condoms and  (water-based) lube. If $134 million were invested in condoms and  lubricant, it could avert 25 percent of the global MSM infections in the  next 10 years. It’s also important to fight stigma and ignorance with  data and information, and to include multi-stakeholders—governments,  service providers, communities of MSM—in the fight against AIDS.

Semugoma wrapped up with a slide titled “Price of Advocacy.” It included  the photos of Aim Mongoche in Cameroon, Steve Harvey in Jamaica, David  Kato in Uganda and Thapelo Makutle in South Africa—advocated who were  beaten, arrested and killed. “It’s tough to achieve comprehensive HIV  prevention and treatment in these contexts,” Semugoma concluded, “but  they have tried. And we continue to try.” The last slide, though, was an  image of Semugoma and his partner in a happy and loving embrace—visible  for all the world to see.

Overs agreed with LGBT activist Peter Piot, who said, “What drives  continued expansion of the pandemic is not the absence of effective  preventative technologies, but discrimination, exploitation and  repression of certain social groups.”
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Condoms vs PrEP

Substantial Minority’ of MSM Would Use Condoms Less When on PrEP

 A “substantial minority” of men who have sex with men (MSM) anticipated that they would use condoms less if they were taking PrEP, or pre-exposure prophylaxis, according to results of a survey  presented Tuesday, July 24, at the XIX International AIDS Conference in Washington, DC.

Specifically, 20 percent of 3,245 respondents said they would decrease condom use while “topping”—engaging in insertive anal sex—while using PrEP.
And 14 percent of 3,237 respondents said they would forgo condoms while “bottoming”—engaging in receptive anal sex—while taking PrEP.

PrEP, which is when an HIV-negative person takes daily medication to prevent potential infection, is a controversial and timely topic. The Food and Drug Administration this month approved the use of the antiretroviral Truvada (tenofovir plus emtricitabine) as PrEP.

A 2010 study called iPrEx showed that among men who have sex with men (MSM) and transgender women, Truvada as PrEP reduced HIV infections by 42 percent. However, not everyone took the meds as prescribed.
Those who followed the daily regime received higher protection—as much as 92 percent.
But in real world settings, will PrEP’s potential benefit be reduced by risk compensation?
In other words, will men who take PrEP perceive themselves to be protected and as a result stop using condoms?
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Drug to Prevent HIV

The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.

  • In a series of votes, a 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-positive partner.

The FDA is not required to follow the panel’s advice, though it usually does. A final decision is expected by June 15.

Gilead Sciences Inc. has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe it as part of a drug cocktail to repress the virus.

While panelists ultimately backed Truvada for prevention, Thursday’s 12-hour meeting highlighted a number of concerns created by the first drug to prevent HIV. In particular, the panel debated whether Truvada might lead to reduced use of condoms, the most reliable defense against HIV. The experts also questioned the drug’s effectiveness in women, who have shown much lower rates of protection in studies.

Panelists struggled to outline steps that would ensure patients take the pill every day. In clinical trials, patients who didn’t take their medication diligently were not protected, and patients in the real world are even more likely to forget than those in studies.

“The trouble is adherence, but I don’t think it’s our charge to judge whether people will take the medicine,” said Dr. Tom Giordano of Baylor College of Medicine, who voted in favor of the drug. “I think our charge is to judge whether it works when it’s taken and whether the risks outweigh the benefits.”

Truvada first made headlines in 2010, when government researchers showed it could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.

Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval would allow Gilead Sciences to formally market its drug for that use.

But Truvada’s groundbreaking preventive ability has exposed stark disagreements on prevention among those in the HIV community. While Truvada’s supporters say the drug is an important new option, critics worry that the drug could give users a false sense of security, and encourage risky behavior.

Other speakers worried that wide scale use of Truvada would divert limited funding from more cost-effective options. Truvada sells for about $900 a month, or just under $11,000 per year. The AIDS Healthcare Foundation, which opposes approval of Truvada, estimates that 20 HIV-positive patients could be treated for the cost of treating one patient with preventive Truvada.

“Truvada for prevention will squeeze already-constrained health care resources that can be better spent on cheaper and more effective prevention therapies,” the group states in a petition to the FDA.

The FDA is legally barred from considering cost when reviewing drugs. Medicare and Medicaid, the nation’s largest health insurance plans, generally cover all drugs approved by the FDA and many large insurers take their cues for coverage from the government plans.

An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body’s immune system to breakdown, leading to infections which are eventually fatal. Gay and bisexual men account for the majority of cases — nearly two-thirds.

The number of new HIV infections in the U.S. has held steady for 15 years at about 50,000 per year. But with no vaccine in sight and an estimated 240,000 HIV carriers unaware of their status, doctors and patients say new methods are needed to fight the spread of the virus.

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.

 

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US embraces treatment as prevention

policy to achieve global ‘AIDS-free

 generation’

Keith Alcorn
  Published: 08 November 2011

The United States is now committed to a policy of creating the first AIDS-free generation by using antiretroviral treatment as the central tool in a strategy to radically reduce new infections, US Secretary of State Hillary Clinton said today.

“HIV may be with us well into the future.  But the disease that it causes need not be,” said Secretary of State Clinton.

“This is an ambitious goal, and I recognise that I am not the first person to envision it.  But creating an AIDS-free generation has never been a policy priority for the United States government—until today”, she said.

“This goal would have been unimaginable just a few years ago.  Yet it is possible, because of scientific advances largely funded by the United States and new practices put in place by this administration and our many partners around the world.  While the finish line is not yet in sight, we know we can get there, because we know the route we need to take.”

Her remarks follow months of internal debate within the US government about how to respond to the results of the HPTN 052 study, which showed that antiretroviral treatment reduced the risk of HIV transmission to regular partners by 96%.

“If we take a comprehensive view of our approach to the pandemic, treatment doesn’t take away from prevention,” she said. “It adds to it.  So let’s end the old debate over treatment versus prevention and embrace treatment as prevention.”

Clinton emphasised the importance of three measures:

  • Prevention of mother to child transmission using antiretroviral drugs. One in seven new infections worldwide occur from mother to child; the United States has worked with other global partners including UNAIDS to develop a strategy to virtually eliminate new infant infections by 2015, by expanding testing and treatment.
  • Voluntary male circumcision reduces the risk of a man acquiring HIV infection by around 60%. PEPFAR has financed three-fourths of the one million male circumcisions for HIV prevention around the world since 2007.
  • Treatment as prevention. The HPTN 052 study showed that earlier treatment massively reduced the risk of HIV transmission, and another US-funded study has shown that treatment before the onset of serious AIDS-defining illness or immune deficiency substantially reduces the risk of developing AIDS or dying.

The announcement was welcomed by activists.

“Secretary Clinton laid out a bold vision today,”said Matthew Kavanagh, Director of US Advocacy for Health GAP. “Her speech could be the foundation for the US administration to lead the world to end the AIDS crisis. And it raises high expectations among all those who heard it: we expect that President Obama will now take leadership and dramatically ramp up PEPFAR antiretroviral treatment targets as well as scaling up other highly impactful prevention technologies.”

“In several countries where we work, we are seeing governments that are ready to act on the new science in order to turn back the toll the virus has taken on their people and their communities. If the US and other governments ramp up their investment in HIV treatment now, we know that millions of lives will be saved and millions more new infections will be averted,” said Dr. Unni Karunakara, International President of Médecins Sans Frontières.

In her remarks, Secretary Clinton called on other donor nations to do more, including by supporting and strengthening the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Partner countries must also take more responsibility for their AIDS programmes, including spending more on fighting their own epidemics.

But Secretary Clinton’s remarks were also addressed to a national audience that is growing increasingly sceptical about overseas aid spending at a time when the United States is engaged in bitter debates about how to limit government spending.

The frontrunner for the Republican presidential nomination, Mitt Romney, has questioned whether the United States should be spending money on poverty relief overseas, and Republicans in Congress are attempting to trim global health spending and prevent any increases in US expenditure on HIV treatment.

“At a time when people are raising questions about America’s role in the world, our leadership in global health reminds them who we are and what we do,” Clinton said.

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