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Truvada’s use as HIV prevention drug raises concerns

Truvada, Gilead, gay news, Washington Blade

Drug resistance to established regimens can be a major concern. (Photo courtesy of Gilead)

NEW YORK — Debate persists in the gay community over the use of Truvada, a drug hailed as a lifesaver for many with HIV, about its use and effectiveness as a prevention technique for uninfected men who have gay sex without condoms, the AP and other news outlets report.

Many doctors and activists see immense promise for such preventive use of Truvada, and are campaigning hard to raise awareness of it as a crucial step toward reducing new HIV infections, which now total about 50,000 a year in the U.S., the AP reports.

Yet others — despite mounting evidence of Truvada’s effectiveness — say such efforts are reckless, tempting some condom users to abandon that layer of protection and exposing them to an array of other sexually transmitted infections aside from HIV.

“If something comes along that’s better than condoms, I’m all for it, but Truvada is not that,” Michael Weinstein, president of the AIDS Healthcare Foundation, was quoted as having said by the AP. “Let’s be honest: It’s a party drug.”

Truvada, produced by California-based Gilead Sciences, has been around for a decade, serving as one of the key drugs used in combination with others as the basic treatment for people who have HIV. However, the drug took on a more contentious aspect in 2012 when the Food and Drug Administration approved it for pre-exposure prophylaxis, or PrEP — in other words, for use to prevent people from getting sexually transmitted HIV in the first place, the AP said.

Since then, critics have warned that many gay men won’t heed Truvada’s once-a-day regimen and complained of its high cost — roughly $13,000 a year. Truvada’s proponents say most insurance plans — including Medicaid programs — now cover prescriptions for it, and they cite studies showing that the blue pill, if taken diligently, can reduce the risk of getting HIV by more than 90 percent, the AP said.

A town hall panel discussion on PrEP is planned for April 28 from 7-9 p.m. at the GLBT Community Center of Baltimore. Visit glccb.org for details.

10
Apr
2014

DC Center, GWU partner in ‘PrEP’ HIV prevention program

Truvada, Gilead, gay news, Washington Blade

(Photo courtesy of Gilead)

George Washington University’s School of Public Health has awarded the DC Center for the LGBT Community a $10,000 grant to provide HIV prevention activities associated with the use of the AIDS drug Truvada as a pre-exposure prophylaxis, or “PrEP” for members of the LGBT community who are HIV negative.

In a statement released on Tuesday, the Center said the grant funds would be used in a “multi-pronged approach of awareness, research, and compliance in an effort to improve the lives of people living with and at risk for HIV in the District.”

Two officials with GWU’s Milken Institute School of Public Health were scheduled to present a $10,000 check to D.C. Center Board Chair Michael Fowler and Center Executive Director David Mariner at a ceremony at the Center’s offices at 4 p.m. Wednesday, April 30.

The Center is located on the ground floor of the city’s Reeves Center municipal building at 14th and U Streets, N.W.

Fowler told the Blade that the Center will not serve as a dispensary for Truvada but instead will provide referrals to medical providers for those interested in going on PrEP. Fowler said the Center, among other things, would send reminders to those on the program to take the pill every day, provide educational seminars on PrEP, and develop a mobile app to help people find a PrEP provider at a location convenient to them.

The Gilead pharmaceutical company, which manufactures Truvada, received approval from the U.S. Food and Drug Administration in 2012 for the use of a doctor prescribed, one-pill-a-day regimen of Truvada as a pre-exposure prophylaxis to help uninfected people reduce their risk of HIV infection.

The U.S. Department of Health and Human Services, which promotes the use of Truvada as part of the PrEP program on its official government website, AIDS.gov, says the program is recommended for population groups considered at “high risk” for HIV infection. Men who have sex with men are among the groups considered at high risk for HIV, according to a write-up on the website.

However, critics of the PrEP program, including the AIDS Healthcare Foundation, the nation’s largest AIDS service providing group which has offices in D.C., point to studies showing that a significant percentage of people on the PrEP program have been non-compliant in taking their daily Pravda pill, placing them at risk for becoming infected with HIV. The group’s director, Michael Weinstein, has said promoting condom use among men who have sex with men is a more effective method of HIV prevention.

In a separate development, D.C. Center spokesperson Matt Corso said the Center’s first AmeriCorps staff person began work at the Center on April 28 and will be with the Center for at least a year.

Corso said the staffer, Eric Perez, will work on the Center’s LGBT military veterans support program. He said Perez is part of AmeriCorps’ Vetcorps program, which supports veterans.

“We are the first LGBT community center to ever receive a Vetcorps volunteer, and this is Vetcorps’ first time looking specifically at the issues LGBT veterans face,” Corso said.

01
May
2014

GLCCB town hall tackles PrEP

Truvada, Gilead, gay news, Washington Blade

(Photo courtesy of Gilead)

On April 28, the Gay, Lesbian, Bisexual and Transgender Community Center of Baltimore and Central Maryland (GLCCB) hosted a town hall at the Waxter Center with 30 people in attendance to discuss the use of pre-exposure prophylaxis, or PrEP, to prevent HIV infection. PrEP is medicine taken daily by HIV-negative people who are at high risk of exposure to HIV, to prevent becoming infected with HIV.

Tenofovir-emtricitabine, or Truvada, manufactured by pharmaceutical company Gilead, is currently the only medication approved for use as PrEP. Truvada is also widely used as part of HIV treatment. At this time, daily pills are the only form of PrEP.

The panelists included Brian M. Palmer, D.O., M.P.H., of Gilead Sciences, Inc.; Dr. Patrick Ryscavage, of University of Maryland Medical Center; Dr. Renata Arrington-Sanders, of Johns Hopkins Hospital; and Deb Dunn of Chase Brexton Health Services.

06
May
2014

Use of HIV prevention pill ‘sluggish’ in D.C. area

Truvada, Gilead, gay news, Washington Blade

Truvada (Photo courtesy of Gilead)

An official with Whitman-Walker Health, D.C.’s largest AIDS treatment and service organization, said that similar to current nationwide trends, a relatively small number of people at risk for HIV infection in the D.C. area are taking a drug approved for preventing them from contracting HIV.

Dr. Richard Elion, Whitman-Walker’s director of clinical research, told the Washington Blade that fewer than 50 Whitman-Walker clients have signed up so far for the prescription drug Truvada, a daily pill approved by the U.S. Food and Drug Administration as a pre-exposure prophylaxis, or “PrEP,” to greatly reduce the chances of becoming infected with HIV.

“So the uptake on PrEP is that the District has been sluggish at most places,” Elion said in discussing the local demand for taking Truvada as a prevention pill.

“It’s important to have a lot of educational efforts on this because this is a prevention strategy that to me has not really gotten the recognition and the press that it deserves,” he said.

Officials with at least three other local organizations that provide AIDS-related services and prevention programs targeting gay and bisexual men – Us Helping Us, SMYAL, and Metro Teen AIDS – said they, too, believe PrEP is an important new prevention strategy that should be encouraged for people deemed at high risk for HIV, especially young gay and bisexual men.

“Us Helping Us fully supports PrEP and will publicize it to our clients through meetings and social media,” said Ron Simmons, the group’s executive director. Us Helping Us reaches out to black gay and bisexual men in the D.C. area on AIDS prevention and other AIDS-related programs.

Adam Tenner, executive director of Metro Teen AIDS, and Andrew Barnett, executive director of SMYAL, each said they are encouraged over the potential PrEP has for their clients, who range in age from 13 to 21. But the two said they have yet to determine whether PrEP is appropriate for youth as young as 13 through 17.

“We are encouraged over the effectiveness of the treatment in preventing infection,” Tenner said. “But we are going to be very cautious about PrEP for adolescents. For kids 18 and older there are fewer questions,” he said.

Tenner and Barnett each said they are awaiting guidance from experts, including pediatricians, on the advisability of prescribing Truvada to people as young as 13 or 14. According to Tenner, youth of that age often are sexually active and at risk for sexually transmitted diseases, including HIV.

He said Metro Teen AIDS sponsors HIV prevention programs targeting youth in that age range but has yet to embrace PrEP for young teens without having access to more information.

The U.S. Centers for Disease Control and Prevention, which earlier this month issued new guidelines advocating the wider use of PrEP for HIV prevention, and the American Academy of Pediatrics didn’t immediately respond to an inquiry from the Blade about the advisability of PrEP for youth between 13 and 17 years old.

The Los Angeles-based AIDS Healthcare Foundation, the nation’s largest AIDS service and treatment organization, which has facilities in D.C. and Maryland, has expressed strong opposition to PrEP, saying it has the potential to discourage condom use.

Michael Weinstein, the organization’s CEO, has pointed to studies showing that large numbers of people enrolled in the studies failed to take the Truvada pill on a daily basis as prescribed, placing them at risk for HIV infection.

Weinstein told the Blade that although AIDS Healthcare Foundation opposes the widespread use of PrEP, it believes it should ultimately be up to a patient and his or her doctor as to whether to enroll in PrEP. He said his organization’s medical clinics, including the one in D.C. and Temple Hills, Md., would not refuse to prescribe Truvada to people who specifically request to go on PrEP.

Sex workers who choose to have intercourse without using a condom would be especially suited for enrolling in PrEP, he said.

Elion disputes claims by AIDS Healthcare Foundation that large numbers of people on PrEP, men who have sex with men, are likely to stop using condoms.

“In the studies that have looked at over 12,000 patients we’ve not seen an increase in STDs in any of the people on PrEP,” Elion said. “And so I think that lack of an increase in STDs is indicative that they are not doing more risky behaviors once they start taking PrEP.”

Weinstein said a lack of an increase in sexually transmitted diseases in people on PrEP doesn’t necessarily mean they aren’t engaging in risky behaviors. He said sexually transmitted diseases other than HIV are at epidemic proportions in the U.S. for gay and bisexual men or MSM.

“The baseline is already very high,” he said.

28
May
2014

Price of new once-daily AIDS drug draws criticism

Truvada, Gilead, gay news, Washington Blade

(Photo courtesy of Gilead)

SAN FRANCISCO — Gilead’s new once-daily AIDS drug Stribild provides an attractive option for those with HIV who have never started a meds regiment before, but activists say the $33,000 a year price-tag will make it unattainable for most who need it.

“In the long run, the cost to Gilead to actually produce [Stribild] will be a small fraction of its selling price, which means Gilead can show restraint on…pricing and still make an enormous profit,” AIDS Healthcare Foundation president Michael Weinstein told the Huffington Post, after a massive ACT UP San Francisco demonstration at the drug maker’s headquarters over the price.

Activists are putting pressure not just on Gilead, but on lawmakers to intervene and making HIV drugs more affordable for more people.

03
Jan
2013