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VIDEO: Ken Like Barbie Talks to Gay Men About "PrEP" HIV Prevention

It was almost one year ago that the Food and Drug Administration approved the antiretroviral medication Truvada to reduce the risk of HIV infection in uninfected individuals. That prevention strategy is known as pre-exposure prophylaxis or PrEP. This became the first medication ever to be approved for HIV prevention in adults, marking a major milestone in the 30-year global epidemic.

Chicago-based YouTube hotness, HIV/AIDS activist and vlogger Ken Like Barbie is featured in smart, sexy and informative video that explains this biomedical intervention. "The frontier of HIV prevention is changing," says Ken. "Instead of just abstinence and condom usage, we now have a pill that we can take to elevate our same sex practices. So, Truvada becomes a safer sex practice in itself."

Ken, entertainer ButtaFlySoul and the Chicago Black Gay Men's Caucus' David Dodd will be the featured guests in a community forum on PrEP tonight at the Center on Halsted in Chicago. The forum will be held will 6P to 10PM.

The video is part of the "My PrEP Experience" multimedia series produced by the AIDS Foundation of Chicago. Watch AFTER THE JUMP ...

PrEP is the daily use of an  antiretroviral drug therapy that has dramatically reduced new infections in HIV-negative gay and bisexual men. Daily use of the cocktail—a combination of Gilead Sciences' Truvada and/or Viread—has shown up to 94 percent efficacy in preventing HIV transmission. PrEP is a comprehensive HIV prevention strategy that should include other prevention methods, such as safe sex and regular HIV testing. It is NOT a "magic pill", researchers and prevention advocates have warned.

The number of new HIV infections in the United States has remained "relatively stable" at about 50,000 per year between 2006 and 2009. But there have been a soaring number of seroconversions among Black men who have sex with men.  The trend has been particularly “alarming” among Black MSM aged 13 to 19, according to the CDC. New infections have increased by 48 percent between 2006 and 2009. See EBONY: "New Data Show Black Gay Men Face "World's Highest" Risk of HIV"

See our recent series "Reversing the Alarming HIV Increase Among Black Gay Men Part 1" and "Part 2", as well as "What Pre-Exposure Prophylaxis Could Mean for Black Gay and Bi Men" and "Clinical Trials Show PrEP Reduces Heterosexual HIV Transmission" that were syndicated by the Black AIDS Institute across Black print and web properties.

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Leading HIV Groups Call on FDA to Approve PrEP
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"Alarming Increase" in HIV Young Black Gay Men
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Minnesota Becomes the 12th State to Allow Marriage Equality

In an historic vote, Minnesota has become the latest state to approve equal marriage. Today's vote in the state senate means that Minnesota will join 11 states and the District of Columbia to allow same-sex marriage.

Minnesota also becomes "the first state in the Midwest" to approve equal marriage by legislative vote, adds KSTP.

The Senate vote of 37-30 came four days after the House passed the bill on a 75-59 vote. When the tally was announced after more than four hours of debate, a huge cheer erupted in the chamber and gallery, where spectators stood and applauded. Minnesota will become the first state in the Midwest to make gay marriage legal via a legislative vote. Iowa legalized same-sex marriage in 2009 through a court ruling.

Last week, Dayton, a Democrat, called the bill "one of those society-changing breakthrough moments." His staff scheduled a signing ceremony for 5 p.m. Tuesday on the Capitol steps.

It's a rapid turnaround for gay marriage supporters, who just six months ago had to organize a massive effort to defeat a constitutional amendment that would have banned gay marriage. The groups who defeated the amendment quickly turned their attention to legalizing gay marriage, and their efforts were aided by Democrats capturing full control of state government in November.

Three Democrats voted against the bill. One Republican voted yes.

Minnesota joins Delaware and Rhode Island to becomes the third state to approve marriage equality in the last two weeks. Minnesota and Rhode Island's laws become effective August 1.

Take that, Michele Bachmann and Tim Pawlenty!

FDA Approves Gilead's New 4-in-1 Pill for HIV Treatment

Good news for many. The Food and Drug Administration has just approved antiretroviral that combines four medications to fight HIV/AIDS. Gilead Sciences' "Stribild" previously known as "Quad" will be a once-a-day treatment for adults who have not previously been treated for infection, reports Reuters.

Stribild contains two previously approved HIV medicines and two new drugs. The older medicines, emtricitabine and tenofovir, are currently sold by Gilead in its combination pill Truvada, which was approved in 2004, and are also part of Gilead's Atripla three-drug combination. The newer drugs are elvitegravir and cobicistat.

[Analysts] expect Gilead to aggressively market Stribild and deemphasize its Atripla and Complera combination therapies as Atripla contains a Bristol-Myers Squibb Co HIV drug and Complera contains a Johnson & Johnson drug. ... As a condition of approval, Gilead will be required to conduct additional studies to help further characterize the drug's safety in women and children, how resistance develops to Stribild, and the possibility of interactions between Stribild and other drugs, the FDA said.

Clinical trials demonstrate the new therapy is more effective in some cases than Atripla, adds the New York Times.

Company studies showed that 88 to 90 percent of patients taking Stribild had an undetectable level of HIV in their blood after 48 weeks, compared with 87 percent for patients taking Atripla, another HIV drug that contains Truvada and one other drug.

Wall Street estimates the new combination pill will earn about $370 million in sales next year.

The announcement comes six weeks after the FDA approved Gilead's Truvada to reduce the risk of HIV infection in uninfected individuals. That prevention strategy is known as pre-exposure prophylaxis or PrEP. Truvada became the first medication ever to be approved for HIV prevention in adults, marking a major milestone in the 30-year global epidemic.

About 1.2 million people in the United States are living with HIV/AIDS, according to the U.S. Centers for Disease Control and Prevention. Blacks are the demographic that are hardest hit. Blacks comprise only 12 percent of the population but about 45 percent of all new infections.

The number of new HIV infections in the United States has remained "relatively stable" at about 50,000 per year between 2006 and 2009. But there have been a soaring number of seroconversions among Black men who have sex with men.  The trend has been particularly “alarming” among Black MSM aged 13 to 19, according to the CDC. New infections have increased by 48 percent between 2006 and 2009. See EBONY: "New Data Show Black Gay Men Face "World's Highest" Risk of HIV"

Some Background:

"Black Gay Men Face "World's Highest" Risk" [EBONY]
FDA Approves Truvada for PrEP
SF First City to Offer PrEP to Gay Men
Leading HIV Groups Call on FDA to Approve PrEP
Preparing for PrEP
"Alarming Increase" in HIV Young Black Gay Men
Daily Drug Reduces HIV Transmission
HIV a Rite of Passage for Young Black Gay Men?
1 in 3 Black Gay Men HIV Positive; 60% Unaware
"Alarming" HIV Rates Young Blk Gay Men in Miss.
CDC: 42% Black Gay Men in Milwaukee are HIV+
HIV "Epidemic" Among Black Gay Chicago Men
CDC: Young Black Gays Hit Hardest by HIV Infections
What PrEP Could Mean for Black Gay Men

FDA Approves Truvada for Pre-Exposure HIV Prevention

The Food and Drug Administration has approved the antiretroviral medication Truvada to reduce the risk of HIV infection in uninfected individuals. The HIV prevention strategy is known as pre-exposure prophylaxis or PrEP.

Truvada becomes the first medication ever to be approved for HIV prevention in adults, marking a major milestone in the 30-year global epidemic.

PrEP is the daily use of an  antiretroviral drug therapy that has dramatically reduced new infections in HIV-negative gay and bisexual men. Daily use of the cocktail—a combination of Truvada and/or Viread—has shown up to 75 percent efficacy in preventing HIV transmission. PrEP is a comprehensive HIV prevention strategy that should include other prevention methods, such as safe sex and regular HIV testing. It is NOT a magic "pill", researchers and prevention advocates have warned.

As a part of this action, the FDA is strengthening Truvada’s Boxed Warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status. The FDA strongly recommends against such use.

As a condition of approval, Truvada’s manufacturer, Gilead Sciences, Inc., is required to collect viral isolates from individuals who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance. Additionally, the company is required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada for PrEP and to conduct a trial to evaluate drug adherence and its relationship to adverse events, risk of seroconversion, and resistance development in seroconverters. Gilead has committed to provide national drug utilization data in order to better characterize individuals who utilize Truvada for a PrEP indication and to develop an adherence questionnaire that will assist prescribers in identifying individuals at risk for low compliance.

There have been some questions about resilience and the impact of powerful antiretrovirals on a healthy immune system. But the major question: Who will pay for the drug? In the United States, Truvada can cost $36 a day or up to $14,000 a year.

The number of new HIV infections in the United States has remained “relatively stable” at approximately 50,000  per year between 2006 and 2009, according to data from the Centers for Disease Control and Prevention (CDC) that was published in August 2011.

But there have been a soaring number of seroconversions among Black men who have sex with men.  The trend has been particularly “alarming” among Black MSM aged 13 to 19, according to the CDC. New infections have increased by 48 percent between 2006 and 2009. New infections rates are much higher in some cities—such as Milwaukee, where an estimated 42 percent of Black gay/bi men could be infected.

See our recent series "Reversing the Alarming HIV Increase Among Black Gay Men Part 1" and "Part 2", as well as "What Pre-Exposure Prophylaxis Could Mean for Black Gay and Bi Men" and "Clinical Trials Show PrEP Reduces Heterosexual HIV Transmission" that were syndicated by the Black AIDS Institute across Black print and web properties.

Some Background:
SF First City to Offer PrEP to Gay Men
Leading HIV Groups Call on FDA to Approve PrEP
Preparing for PrEP
"Alarming Increase" in HIV Young Black Gay Men
Daily Drug Reduces HIV Transmission
HIV a Rite of Passage for Young Black Gay Men?
1 in 3 Black Gay Men HIV Positive; 60% Unaware
"Alarming" HIV Rates Young Blk Gay Men in Miss.
CDC: 42% Black Gay Men in Milwaukee are HIV+
HIV "Epidemic" Among Black Gay Chicago Men
CDC: Young Black Gays Hit Hardest by HIV Infections
What PrEP Could Mean for Black Gay Men

Leading HIV/AIDS Groups Call on FDA and Gilead to Approve PrEP

Thirteen prominent U.S. HIV/AIDS organizations have written an open letter to the Food and Drug Administration and Gilead Sciences calling for "prompt regulatory review" of  pre-exposure prophylaxis (PrEP) for gay/bisexual men and transgender women.

PrEP is the daily use of an  antiretroviral drug therapy that has dramatically reduced new infections in HIV-negative gay and bisexual men. Daily use of the cocktail—a combination of Truvada and/or Viread—has shown up to 73 percent efficacy in preventing HIV transmission.

The letter urges regulators and the drug manufacturer  "not to delay review "because of distinct questions about the safety and efficacy of PrEP in heterosexual cohorts.

The letter reads in part:

Data from multiple clinical trials in different populations showing that antiretroviral drugs for HIV treatment can also prevent HIV infection have accumulated to the point where FDA approval decisions could be made for this intervention. The approval issues for the different populations are not identical. For the reasons outlined below, we urge the FDA and Gilead Sciences to reconsider plans to combine the approval for a prevention indication for both men who have sex with men, including transgender populations (MSM) and heterosexuals into a single filing.

The combination could unnecessarily delay approval for MSM, the group at greatest risk of HIV infection in the United States.

There have been some questions about resilience and the impact of powerful antiretrovirals on a healthy immune system. But the major question: Who will pay for the drug? In the United States, Truvada can cost $36 a day or up to $14,000 a year.

"We desperately need new strategies and tools to reduce the rapidly increasing rates of HIV infection in black gay and bisexual men," says Phill Wilson, executive director of the Black AIDS Institute.  "We've had evidence of PrEP's effectiveness in MSM for almost a year now. It's time to use every tool at our disposal to reduce the 50,000 new HIV infections that occur each year in this country. "

The groups include AIDS Foundation of Chicago, AIDS United, AVAC, Black AIDS Institute, Fenway Health, GMHC, Harlem United, and the National Minority AIDS Council.

The news comes after the release of disturbing HIV seroconversion data. New HIV cases among Black gay and bisexual men aged 13-29 rose an estimated 48 percent between 2006-2009, according to the Centers for Disease Control and Prevention. New infections rates are much higher in some cities—such as Milwaukee, where an estimated 42 percent of Black gay/bi men could be infected.

See our recent series "Reversing the Alarming HIV Increase Among Black Gay Men Part 1" and "Part 2", as well as "What Pre-Exposure Prophylaxis Could Mean for Black Gay and Bi Men" and "Clinical Trials Show PrEP Reduces Heterosexual HIV Transmission" that were syndicated by the Black AIDS Institute across Black print and web properties.

San Francisco First City to Offer Anti-HIV PrEP to Gay Men

San Francisco will soon become the first city in the nation to offer pre-exposure prophylaxis (PrEP), the daily use of an  antiretroviral drug therapy that has dramatically reduced new infections in HIV-negative gay and bisexual men.

Daily use of the cocktail—a combination of tenofovir and Truvada—has shown up to 73 percent efficacy in preventing HIV transmission. The demonstration project would launch in early 2012, reports the Bay Area Reporter.

Under the contract, up to 300 men who have sex with men at high risk for contracting HIV would be enrolled in the pilot study. City Clinic would administer the program while Magnet, the gay men's health center in the Castro, would help identify suitable participants for the study.

The exact funding amount for the National Institutes of Health Implementation Science Study is still being determined. And San Francisco is expected to partner with counterparts in Miami on the study to see if gay men want to use PrEP, and if so, how to safely administer the medical prevention technique.

Magnet Director Steve Gibson told the B.A.R. that, so far, few of the clinic's patients have asked about the HIV prevention tool or its availability. Those who have, he said, either took part in the iPrEx clinical trials, known locally as PREPARE, or are HIV-negative men who have HIV-positive partners. Some of the questions Gibson said he hopes the demo project will answer are not only how gay men adopt using PrEP but also how to ensure lower income gay and bi men and men of color have access to it.

Some critics of PrEP believe its availability will encourage more gay men to engage in risky sexual practices. Others are concerned about resilience and the impact of powerful antiretrovirals on a healthy immune system. But the major question is who will pay for the drug: In the United States, Truvada can cost $36 a day or up to $14,000 a year.

The news comes after the release of disturbing HIV seroconversion data. New HIV cases among  Black gay and bisexual men aged 13-29 rose an estimated 48 percent between 2006-2009, according to the Centers for Disease Control and Prevention. In San Francisco, Black men account "for the highest incidence rates of HIV cases among men," BAR reported in May.

Some Background: 
Preparing for PrEP
"Alarming Increase" in HIV Young Black Gay Men
Daily Drug Reduces HIV Transmission
HIV a Rite of Passage for Young Black Gay Men?
1 in 3 Black Gay Men HIV Positive; 60% Unaware
"Alarming" HIV Rates Young Blk Gay Men in Miss.
CDC: 42% Black Gay Men in Milwaukee are HIV+
HIV "Epidemic" Among Black Gay Chicago Men
CDC: Young Black Gays Hit Hardest by HIV Infections
What PrEP Could Mean for Black Gay Men

REPORT: Gilead Raises HIV Drug Costs Despite ADAP Cuts

Pharmaceutical giant Gilead Sciences has raised the prices of its life-saving and very expensive anti-retrioviral HIV meds, despite the fact that almost 8,000 people are on waiting lists for the AIDS Drug Assistance Program, reports POZ.

The cost of Atripla went up by 5.1 percent, while Truvada and Emtriva increased by 7.9 percent. Although Gilead is maintaining a price freeze for drugs going toward ADAP, the price increase can further stress the overburdened health care system including Medicare, Medicaid and private insurance companies.

Change.org adds: "Just a few months ago, AIDS Healthcare Foundation called for the top pharmaceutical companies (including Gilead) to decrease the prices of their medications to assist with the ADAP crisis. The goal was to inspire Pharma to assist in the crisis by helping ease the financial burden off state and federal funds."

Gilead's Truvada, which recently made news in studies for post- and pre-exposure prophylaxis, can cost up to $14,000 per year.

The recession has forced a number of states to slash funding to the AIDS Drug Assistance Program, the federal/state program that helps low-income, people living with HIV/AIDS pay for their expensive, life-saving medications. Those in the program are disproportionately black, many of the men are gay or bisexual.

In 2010, at least a dozen states closed enrollment in ADAP. Three other states have narrowed eligibility and two of them—Arkansas and Utah—dropped scores from the program. HIV/AIDS service organizations say "an emergency appropriation of at least $126 million" is needed. Virginia recently closed enrollment in its ADAP program.

What Pre-Exposure Prophylaxis Could Mean for Black Gay Men

The first in our two-part series for the Black AIDS Institute: What Pre-Exposure Prophylaxis Could Mean for Black Gay Men.

In what has been described as a "major breakthrough", the daily use of an antiretroviral drug therapy has been revealed to dramatically reduce new infections in HIV-negative gay and bisexual men. But "how do you implement it for the number one risk group for HIV/AIDS: African American men who have sex with men?" asks Detroit-based Hank Milbourne, director of prevention services at AIDS Partnership Michigan.

A recent CDC study  found that almost one in three Black men who have sex with men is HIV positive, compared with only 16 percent of White gay and bisexual men. More than 60 percent are not aware of their HIV status.

Read the full report HERE.

Also, Black AIDS Institute President Phill Wilson wraps new research and policy developments around PrEP.

Daily Use of Drug Greatly Reduces HIV Transmission in Gay/Bi Men

In what has been described as a "major breakthrough", the daily use of an antiretroviral drug therapy has been revealed to dramatically reduce new infections in HIV-negative gay and bisexual men. The results of clinical trials involving Truvada, a combination of tenofovir and emtricitabine, open a new line of attack in HIV protection and prevention known as pre-exposure prophylaxis (PrEP).

  In the study, published Tuesday by the New England Journal of Medicine, researchers found that the hundreds of gay men randomly assigned to take the drugs were 44 percent less likely to get infected than the equal number assigned to take a placebo. But when only the men whose blood tests showed they had taken their pill faithfully every day were considered, the pill was more than 90 percent effective, said Dr. Anthony S. Fauci, head of the division of the National Institutes of Health, which paid for the study along with the Bill and Melinda Gates Foundation. "That’s huge," Dr. Fauci said.

The large study, nicknamed iPrEx, included nearly 2,500 men in six countries and was coordinated by the Gladstone Institutes of the University of California, San Francisco. The results are the best news in the AIDS field in years, even better than this summer’s revelation that a vaginal microbicide protected 39 percent of all the women testing it and 54 percent of those who used it faithfully.

The study found even higher rates of effectiveness, up to 73 percent, among men who adhered most closely to the daily drug regimen.

The clinical trials only tested the results of "pre-exposure prophylaxis" among men who have sex with men. The results may not apply to other transmission modes, such as male-female sex, injection. But experts say PrEP is a breakthrough because it's a new form of protection available to men, especially those who cannot use condoms because they are sex workers, in prison, under pressure from partners or lose their inhibitions when using drugs. The new form of protection "does not involve getting permission from the other partner, and that’s important," said Phill Wilson, president of the Black AIDS Institute, who describes PrEP as a "one of the most promising prevention tools on the horizon." 

Wilson adds: "But we want to caution people from misinterpreting the results. Condom use and decreasing sexual partners remain the most effective way for gay and bisexual men to protect against HIV infection. PrEP should only be an additional tool."

The new data is especially critical in the Black community because Black gay/bisexual men "continue to be hard hit by HIV/AIDS," Wiilson adds. New data from the Centers for Disease Control show almost one in three Black men who have sex with men are HIV positive. More than 60 percent are not aware of their HIV status.

FDA: Truvada Ad is "Misleading"

The Food and Drug Administration (FDA) has warned pharmaceutical giant Gilead Sciences Inc. that the print advertising for its HIV/AIDS medication Truvada is "misleading" and claims the drug is more effective in the long term than it really is. The FDA has ordered Gilead to "immediately cease" the ad, reports the San Francisco Business Times reports.

The print ad in question shows photographs of a woman at a graduation, in an office  and then married woman sitting on a sofa. The text reads, “With once a day Truvada for my HIV, I can plan for long-term success.”

The FDA maintains the ad suggests that patients using Truvada can manage their HIV-1 RNA levels, or viral loads,  and increased T-cell count on a long-term basis. That has not been demonstrated by "substantial evidence'," regulators say.

More information HERE ...