Don't Delay HIV Prevention for Gay and Bi Men

via The Huffington Post, by David Ernesto Munar

Lives will be saved when the Food and Drug Administration puts its stamp of approval on a groundbreaking preventative approach called pre-exposure prophylaxis, or PrEP, recently found to reduce HIV infections.

With PrEP, people who are not infected with HIV take a daily pill, usually used to treat the disease, to help prevent infection -- as part of a broad HIV prevention approach that includes condoms and safer-sex counseling.

But the longer the FDA waits before beginning its review of the HIV medication Truvada for prevention, the more lives will be unnecessarily lost. This is particularly true for those at greatest risk: gay and bisexual men.

We urge the FDA to immediately begin its review for approval of Truvada for PrEP for gay and bisexual men.

Last year the iPrEX trial, touted as the scientific breakthrough of the year by TIME magazine, found that gay, bi and other men who have sex with men who took Truvada, along with counseling and condoms, had 42 percent fewer HIV infections than with counseling and condoms alone. Among those who used the prevention pill most consistently, the drop in infections was far greater.

And remember the sobering context: between 2006 and 2009, the number of young gay African-American men infected with HIV in the United States increased by 48 percent, according to the U.S. Centers for Disease Control.

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.]

HIV/AIDS Organizations Tell FDA and Gilead Sciences: Don’t Delay HIV Prevention for Gay and Bisexual Men and Transgender Women

[Press Release - October 18, 2011]

Thirteen prominent U.S. HIV/AIDS organizations have issued an open letter to the U.S. Food and Drug Administration and Gilead Sciences calling for prompt regulatory review of pre-exposure prophylaxis (PrEP) for HIV prevention in gay and bisexual men and transgender women (men who have sex with men, or MSM). The letter urges FDA and Gilead to start the review process that could allow safe and appropriate approved PrEP use as a public health intervention, and not to delay review because of distinct questions about the safety and efficacy of PrEP in heterosexual populations.

[The letter is available online here. IRMA is a signatory.]

Pre-exposure prophylaxis, or PrEP, is a new HIV prevention method in which an uninfected person takes a daily HIV medication to reduce HIV infection risk. Data from an international study released in November, 2010 called iPrEx found that men and transgender women who have sex with men who received a daily single-tablet dose of the HIV drugs tenofovir and emtricitabine along with condoms and safe sex counseling had an average of 42% fewer HIV infections than those who received condoms and counseling alone.

Advocates assert that the need for new HIV prevention strategies for MSM is urgent. The U.S. Centers for Disease Control (CDC) estimates that MSM account for more than half of all new HIV infections in the United States. CDC logged an estimated 34% increase in HIV infections in young gay men between 2006 and 2009, and a 48% HIV increase among young black/African American gay men over the same period.

“We desperately need new strategies and tools to reduce the rapidly increasing rates of HIV infection in black gay and bisexual men,” said 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. Prompt FDA review will help ensure that appropriate guidelines for PrEP use are established that can reduce HIV infections and safeguard public health.”

Data on PrEP in heterosexuals raise important but unique questions that may require further study. Two major trials in Africa found that PrEP reduces HIV infection risk in heterosexual men and women substantially. But two other studies present conflicting information about how PrEP works in heterosexuals. Critical and necessary efforts to understand how PrEP interacts with hormonal contraception, or how PrEP may impact pregnancy, however, should not delay access to a potentially lifesaving form of HIV prevention for MSM.

Before the results of the heterosexual PrEP studies were announced, the FDA and Gilead Sciences, the maker of the drugs, were reported to be ready to move quickly to consider approval of PrEP for those MSM who could benefit from the approach. Recent signs indicate, however, that FDA review of PrEP for this population may not start until the agency acquires more data on PrEP among heterosexuals—despite the urgent need for new HIV prevention strategies for MSM, and the fact that PrEP data in MSM were announced nearly one year ago.

“The FDA and Gilead Sciences should move quickly to ensure a thorough review of PrEP for MSM now, while they both work simultaneously and swiftly to thoroughly address questions and concerns about PrEP among heterosexual populations,” said Mitchell Warren, executive director of AVAC “Prompt FDA review of PrEP in MSM is the right thing to do for public health. In the midst of a growing HIV epidemic, HIV prevention delayed is HIV prevention denied.”


[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.]

A Donor Deferred: The Lifetime Ban on Blood Donations from Gay Men

via The Huffington Post, by Robert Valadez

"Save a life, give blood," read the sticker on a colleague's lapel. It sounds wonderful -- where do I sign up? Unfortunately, I can't donate blood because I'm gay. Many people are surprised to hear that gay men are prohibited from donating blood in most countries around the world, including the U.S. I've sat at several dinner parties, perched atop my advocacy soapbox, informing straights and gays alike of the U.S. Food and Drug Administration's (FDA) policy that permanently defers any man who has had sex with another man, even once, since 1977, from donating blood.

It wasn't long ago that I was unaware of the policy. Like many college students across the nation, I happily signed up to donate blood at the campus blood drive. In fact, I rallied a group of friends to join me in participating in one of our country's most noble civic duties. One by one, we were called to donate. However, when my name was called, I was escorted to speak with a phlebotomist rather than fitted with an arm tie and stress ball. I was informed that my blood would not be accepted. Not today, not ever again. It had nothing to do with having consumed questionable British meat products or having a deficiency in iron. Rather, I had answered yes to the question -- the one that asked if I had had sex with a man since the 1970s. Given that I was born in the 1980s, the question seemed oddly phrased to me, not to mention unclear as to the definition of sex. Regardless, I checked the box, unaware of its repercussions. Suddenly, I was blacklisted.

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.]

Pro/Con: Two views of U.S. prohibiting gay men's blood donation

via The Los Angeles Times, by Jessica Pauline Ogilvie

Last month, the United Kingdom lifted its long-standing ban on accepting blood donations from gay men. Instead, health officials there implemented a new policy that allows men to become blood donors as long as they haven't had sex with another man in the previous year.

With this decision, the U.K. joined France, Italy, Japan and eight other developed countries in allowing gay and bisexual men to contribute to the nation's blood supply. Many of those countries require sexually active gay men to wait a year before giving blood, while others have deferral periods of six months or five years. Some countries have regulations that focus on potential donors' risky sexual behavior rather than their sexual orientation.

In the United States, however, men who have sex with men are still subject to a lifetime ban on donating blood. The U.S. Food and Drug Administration implemented the ban in 1983 after an estimated 10,000 people with the bleeding disorder hemophilia became infected with HIV through transfusions of HIV-tainted blood.

That policy has become increasingly controversial in recent years. Some experts in the field of blood safety — as well as gay rights activists — say that it's discriminatory and that scientific advances in testing for HIV render it obsolete. Many would like to see the policy changed to resemble the U.K.'s one-year deferral policy or have the ban lifted altogether.
On the other side of the debate are those who say that men who have sex with men still face a heightened risk of contracting HIV and that even a small increased threat to the blood supply isn't justifiable.

The issue has divided major U.S. health organizations. Last year, the FDA denied a request to overturn the ban, but the American Red Cross and others support moving to a one-year deferral.

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.]

AIDS Health Foundation (AHF) Questions Truvada's Use as PrEP

via Business Wire News Releases, by AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF) unveiled a new print ad today that lays out data on the use of Gilead's blockbuster HIV treatment drug Truvada as a pre-exposure prophylaxis (PrEP) or HIV prevention pill raising questions about the wisdom of pursuing approval by the U.S. Food & Drug Administration (FDA) for this new use of the drug. The information detailed in the "Gilead's Truvada as Prevention - Just the Facts" ad illuminates the reasons why it is premature for the U.S. Food & Drug Administration to consider approval of Truvada as PrEP. In the ad, AHF also calls on Gilead "to make certain that their drug when used for prevention does no harm to the individual or the overall public health."

The ad is scheduled to begin running this week in eight publications aimed at an LGBT (Lesbian, Gay, Bisexual and Transgender) audience: Bay Area Reporter in San Francisco, California; GA Voice in Atlanta, Georgia: Gay City News in New York, New York; South Florida Gay News in Miami/Ft. Lauderdale, Florida; Washington Blade in Washington, D.C.; and Windy City Times in Chicago, Illinois. It will begin running next week in the following publications: Frontiers Magazine in Los Angeles, California and Out Front in Denver, Colorado.

The push for FDA approval of PrEP has increased since November 2010 when the results of the iPrEx study were released. The study of 2,499 high-risk men who have sex with men (MSM) found that the once-daily pill could decrease the likelihood of HIV infection by 42%. Since then many have raised concerns about the consequences of widespread use of PrEP and its possible affect on behavior. Letters signed by 618 doctors and advocates have been sent to the FDA and to drug-maker Gilead Sciences urging a halt to pursuit of FDA approval for use of Gilead's blockbuster AIDS treatment drug Truvada as PrEP. In the letter sent by doctors--spearheaded by AHF--the doctors expressed concern that widespread use of PrEP, based on the available data, will unwittingly lead to more risky behavior, and more HIV infections. Lack of real-world data has also been cited as a concern.

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.]

HIV Experts Create the Roadmap for Providing PrEP to Uninfected Individuals to Reduce the Risk of HIV Infection

Press release via Forum for Collaborative HIV Research

To stem the estimated 2.6 million new HIV infections that occur worldwide each year, more than 200 representatives from the scientific and HIV/AIDS communities took an important step in assessing the safety and public health implications of providing antiretroviral drugs to uninfected men and women exposed to HIV through sexual contact – a strategy called pre-exposure prophylaxis, or PrEP.

Assembling August 19 at an open public meeting and interactive webcast convened by the Forum for Collaborative HIV Research, these researchers, HIV/AIDS advocates, members of industry and representatives from National Institutes of Health, the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and state public health departments applied the findings from a number of large trials to discuss a roadmap for FDA and CDC to develop guidance on the safe use of PrEP in otherwise healthy individuals at high risk of acquiring HIV. Held with the encouragement of FDA, this meeting has important implications for medical practice in the U.S. because recent data strongly support the efficacy of antiretroviral intervention for this purpose.

Although FDA has not yet approved PrEP to reduce HIV acquisition in uninfected individuals, one form of PrEP recently studied for use in healthy men or in couples where one partner is HIV positive –a daily pill containing tenofovir plus emtricitabine (TDF/FTC) – is FDA-approved for the treatment of HIV infection. In women, studies have also demonstrated the efficacy of prophylactic treatment with tenofovir applied as a vaginal gel.

“We now have findings from large studies that support a conclusion that PrEP is effective in gay and bisexual men, who represent more than half of new HIV infections in the U.S., and now, there is evidence that PrEP may reduce HIV infection in heterosexual men and women, the population hardest hit by HIV worldwide,” said Jur Strobos, MD, Deputy Director of the Forum. “We must however, apply these promising data to develop workable strategies that mitigate risk that may be associated with the prophylactic use of antiretrovirals. These include both medical and socio-behavioral risk. We must ensure that people at greatest risk for acquiring HIV receive a comprehensive package of prevention services, including regular HIV testing, condom provision, risk reduction counseling and management of other sexually transmitted infections. The purpose of our meeting was to help identify what the components of a complete package should be.”

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.]

HIV drug-prevention strategy carries risks

Via Nature News, by Erika Check Hayden.

When the US Food and Drug Administration approved Viagra in 1998, officials never considered one possible side effect of the drug: higher rates of sexually transmitted diseases among men who, thanks to Viagra, would become more sexually active. A powerful tool in the fight against HIV is raising similar questions about the possibility of unintended public-health consequences if drugs are approved for use in healthy people and cause them to alter their behaviour.

Several studies in the past year have reported that the very drugs used to treat people with HIV can also stop healthy people from becoming infected (see table). But people taking the drugs may adopt riskier behaviours because they feel protected — a phenomenon known as 'risk disinhibition' — undermining the benefit of the drugs and potentially infecting others. Moreover, those who become infected while taking the preventive regimen might develop drug-resistant viruses that they could then transmit to others. "You have this wonderful scientific breakthrough," says Kevin Frost, chief executive of the Foundation for AIDS Research in New York City. "But what are the practical implications?"

Researchers will mull over these issues on 19 August at a meeting convened by the Forum for Collaborative HIV Research in Washington DC. The questions have become more urgent since January, when the drug firm Gilead of Foster City, California, announced that it plans this year to ask the Food and Drug Administration (FDA) to approve its HIV drug Truvada for use in healthy people — in what is known as pre-exposure prophylaxis, or PrEP. Truvada, which contains the antiretroviral drugs tenofovir and emtricitabine, has been used in many of the PrEP trials. In the three clinical trials that have reported benefits for PrEP so far, once-a-day pills have cut a person's risk of acquiring HIV by between 44% and 73%, a variation that is due primarily to differences in how strictly patients stuck to the daily regimen. Although the need for PrEP is greatest in poor countries, approval in the United States could greatly expand the market for Truvada, which generated US$2.65 billion in sales last year.

Read the rest 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.]

U.S. to Take Another Look at Gay Blood Donation Ban

Via the National Journal, by Maggie Fox.

A policy that bars gay men from donating blood for life is “suboptimal,” advisers to the Health and Human Services Department said on Tuesday, and needs another look.

HHS asked a committee of experts on blood and tissue donations to reexamine the policy and see if there is a way to let at least some gays donate blood.

“If the data indicate that a change is possible while protecting the blood supply, we will consider a change to the policy,” HHS said in a statement.

The U.S. Food and Drug Administration, an HHS agency, has banned blood donation by any man who has had homosexual sex because of the risk of the AIDS virus. Soon after the AIDS pandemic began in the 1980s, people such as hemophiliacs who received frequent blood transfusions or blood products began to become infected with the deadly and incurable virus.

Men who have sex with other men, including gay and bisexual men, have an HIV infection rate 60 times higher than that of the general population, the FDA says. They have an infection rate 800 times higher than first-time blood donors and 8,000 times higher than the rate of repeat blood donors. Tests cannot pick up a new HIV infection in the blood with 100 percent accuracy; because blood is often pooled, many people may be at risk from a single infected donor.

But the Red Cross, always struggling with blood shortages, and other groups such as gay-rights organizations oppose the blanket policy. They say that there are other ways to screen out donors at high risk of HIV infection. Sen. John Kerry, D–Mass., has also been pushing for a change in policy.

“We’ve been working on this a long time in a serious way, and I’m glad Secretary [Kathleen] Sebelius responded with concrete steps to finally remove this policy from the books,” Kerry said in a statement. “HHS is doing their due diligence, and we plan to stay focused on the endgame – a safe blood supply and an end to this discriminatory ban.”

Read the rest 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.]

FDA Panel Recommends HPV Vaccine to Prevent Anal Cancer

via Medscape, by Emma Hitt, PhD

Human papillomavirus (HPV) quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant (Gardasil; Merck), was recommended for an expanded indication — prevention of anal cancer in males and females ages 9 through 26 years — at a US Food and Drug Administration (FDA) advisory panel meeting yesterday.

The FDA's Vaccines and Related Biological Products Advisory Committee mulled over the recent data to consider the expanded indication.

Panelists were asked to comment on 2 discussion topics: the strength of the data to support an indication for the prevention of anal intraepithelial neoplasia (AIN) and anal cancer in males and the scientific rationale for extrapolating efficacy in the prevention of AIN and anal cancer to females.

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.]

FDA to Fast Track 1% Tenofovir (Press Release)

Press Release from CONRAD

October 25, 2010, Arlington, VA - - The U.S. Food and Drug Administration (FDA) held an end-of-Phase II meeting to determine the next steps required for U.S. licensure of 1% tenofovir gel, a microbicide product recently found to be effective at  reducing the rate of HIV and herpes infection in women when used before and after sex.

The meeting, held on October 20, 2010, was requested by CONRAD, a division of the Eastern Virginia Medical School in Norfolk, VA. CONRAD was one of the partners in the Phase II study, “CAPRISA 004,” which evaluated 1% tenofovir gel in prevention of male-to-female HIV transmission in 889 women in South Africa. USAID provided funding for the trial, conducted by the Centre for Programme Research for AIDS in South Africa and U.S. based FHI, which was the first study to show that a vaginal gel can reduce the risk of HIV and herpes infection in women. CONRAD manufactured and provided the tenofovir gel for the study.

Tenofovir gel was found to be 39% effective in reducing a woman’s risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections in the women participating in the trial. Results of the CAPRISA 004 clinical trial were reported in July 2010 and represent the first “proof of concept” for a vaginal microbicide.

A number of key stakeholders contributed to the collaborative meeting with the FDA, including representatives from the U.S. National Institutes of Health, the U.S. Agency for International Development, Gilead Sciences, Microbicides Trial Network (MTN), South African clinical investigators, the International Partnership for Microbicides (IPM) and FHI.

During the meeting, the FDA stated their preference for two well-controlled studies to verify the safety and efficacy of 1% tenofovir gel prior to submission of a New Drug Application (NDA). The FDA furthermore stated that the NIH-sponsored Phase IIB study, MTN-003, known as VOICE (Vaginal and Oral Interventions to Control the Epidemic), represents a second adequate and well-controlled study that would, if successful, serve as the second pivotal trial together with CAPRISA 004 to support the submission of an NDA for 1% tenofovir gel.

In addition, the FDA has granted Fast Track approval designation for 1% tenofovir gel, which facilitates the development and expedites the review of drugs that are intended for treating serious diseases and fill an unmet medical need. With Fast Track designation, an NDA can be submitted as a “rolling review”, which allows a clinical trial sponsor to submit completed sections of its NDA for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.

The agency agreed that the current preclinical program for 1% tenofovir gel is sufficient to support a future NDA. However, they stated that additional safety data on adolescents would be needed and that information on in vivo drug interaction studies with commonly used vaginal products should be obtained. Also, the FDA will ultimately need data on post menopausal women. It was also agreed that a future meeting with the FDA would be held to address any outstanding discussions associated with product quality, including chemistry, manufacturing and controls (CMC). Since much of the clinical work on 1% tenofovir gel has been and will be conducted in South Africa, FDA officials indicated that they can work through the FDA’s “Office of International Programs” with the goal of coordinating the data and review processes with the South African Medicines Control Council.

CONRAD and its partners appreciate the contributions and detailed recommendations put forth by the FDA, which have helped clarify the next steps required for testing and licensure of 1% tenofovir gel.

In 2006, CONRAD and IPM obtained a co-exclusive, royalty-free license from Gilead Sciences to develop 1% tenofovir gel as a topical microbicide for use by women in developing countries to prevent HIV.