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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

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

Hobby Lobby and the war on women

Hobby Lobby, gay news, Washington Blade

Hobby Lobby (Photo by Mike Kalasnik; courtesy Wikimedia Commons)

The Supreme Court continued its war on women with the decision in Sebelius v. Hobby Lobby.

The case was about whether the religious owners of Hobby Lobby stores could determine which contraceptive devices they will include in the health insurance they make available to their employees based on their own religious beliefs rather than on the requirements of the Affordable Care Act, which guarantees access to coverage for all approved FDA contraceptive devices.

Organizations like The Becket Fund for Religious Liberty, a right-wing group supported the owners of the Hobby Lobby stores. They contend they could use their own religious beliefs and transfer those to the business, a corporation closely held by the family, to determine these decisions.

Walter Dellinger, acting solicitor general in the Clinton administration, posited correctly in an op-ed in the Washington Post, that the result of what the owners of Hobby Lobby asked the court to sanction was the ability to, “Selectively deny insurance coverage for contraceptive methods an employer considers sinful effectively making the employer a party to a woman’s medical consultations.”

Those of us who believe in the separation of church and state had hoped this issue had been decided long ago and that it would be evident that Hobby Lobby violated that separation. But clearly that isn’t the case. In its decision, the court held that “closely held corporations cannot be required to provide contraception coverage.” They went further and held, “The government has failed to show that the mandate is the least restrictive means of advancing its interest in guaranteeing cost-free access to birth control.” In his concurring opinion Justice Kennedy wrote, “The government could pay for the coverage itself, so that women receive it.” What the court said is that it is fine for the corporation to discriminate against women and make them figure out another way to get their health coverage.

This decision, following on others such as the denial of a buffer zone at Planned Parenthood sites, makes it even more urgent for those who believe in both women’s rights and the strict separation of church and state to vote in the 2014 mid-term elections and keep the Senate in Democratic hands. The focus must then turn to ensuring that a Democrat is elected president in 2016. It is clear that as long as the right wing controls the Republican Party, their victories will mean the appointment of justices at all levels who don’t believe women should control their healthcare or in the clear separation of church and state.

When a corporation with 13,000 employees can justify even some healthcare decisions based solely on the owners’ religious beliefs there is a problem. We need to work to stop our nation from continuing down this path of blurring the separation of church and state even further.

On the positive side, the court did hold that its decision “concerns only the contraceptive mandate and should not be understood to mean that all insurance mandates, that is for blood transfusions or vaccinations, necessarily fail if they conflict with an employer’s religious beliefs.”  It also apparently does not provide a shield for employers who might cloak illegal discrimination as a religious practice such as discrimination against the LGBT community. But this makes it even clearer that this is a decision against women’s rights by five old white men.

What saved this week from being one of total depression for me was being fortunate to have had the opportunity to listen to the final sermon from Pastor Dean Snyder at Foundry United Methodist Church before his retirement. Snyder spoke of God’s love for all people and that we are all equal in his/her eyes. For 12 years, Dean Snyder has been senior pastor at Foundry and with his wife Jane has been a tower of strength standing up for individual rights. Together they have shown a clear understanding of the separation of church and state even when their own denomination disagreed.

He preached that God doesn’t discriminate. Snyder practiced his faith and stood with the homeless and poor; the downtrodden and the marginalized. Both he and Jane have been leaders in the movements to ensure that civil law is applied equally to all. Listening to Snyder has been inspirational even though I am not a Methodist. He always made me, as he did everyone with whom he came in contact, feel at home at Foundry and he restored my faith in religion.

For all those who believe in women’s rights and the sanctity of the separation of church and state, the Hobby Lobby case should be a rallying cry to elect candidates at all levels of government who share those beliefs.

03
Jul
2014

Calif. lawmaker urges FDA to end gay blood ban

Rep. Mike Honda  (Blade photo by Michael Key)

Rep. Mike Honda (Blade photo by Michael Key)

SAN JOSE, Calif. — A Bay Area congressman is calling on the Food and Drug Administration to lift the ban preventing gay and bisexual men from donating blood, a California-based NBC news affiliate reports.

Mike Honda (D-San Jose) started an online petition to try to get the FDA to overturn the ban. He says the ban is outdated, discriminatory and based on decades-old fears that have been discounted by science.

“The FDA should end the ban and revise its policy and focus on behavior and individual risk, and not on sexual orientation,” Honda said Monday.

After holding a news conference Monday afternoon, Honda was joined by other leaders — including Santa Clara County District Attorney Jeff Rosen and County Supervisor Dave Cortese — for a blood drive outside the county administration building on Hedding Street.

“Despite tremendous advances in the medical and biotech fields, the Food and Drug Administration still bans blood donations from gay and bisexual men,” said Honda. “The American Medical Association now opposes this discriminatory and outdated restriction. Our society is increasingly supporting equality for LGBT people. I will fight this ban that only marginalizes, stigmatizes, and stereotypes healthy people across the country.”

 

09
Jul
2014

AMA backs lifting FDA gay blood ban

blood, gay news, Washington Blade

Advocates have been calling for an end to the lifetime ban on blood donations by gay men for years. (Photo by Daniel Gay via Wikimedia Commons)

CHICAGO — The American Medical Association — the nation’s largest association of physicians — has officially backed a plan to lift the FDA lifetime ban on blood donation by men who have sex with men.

The blood ban was put in place in 1983 at the onset of the AIDS pandemic, but many HIV/AIDS experts now call the policy antiquated. According to ABC News the AMA will back a policy that mirrors those in other nations, which will allow gay men to donate blood if they’ve abstained from sex with other men for a period of time.

“The lifetime ban on blood donation for men who have sex with men is discriminatory and not based on sound science,” AMA board member Dr. William Kobler said in a statement. “This new policy urges a federal policy change to ensure blood donation bans or deferrals are applied to donors according to their individual level of risk and are not based on sexual orientation alone.”

The United Kingdom and Australia allow gay men who have been abstinent for at least one year to donate blood.

26
Jun
2013

Drawing blood

Mary Coble, blood, art, gay news, Washington Blade

Performance artist Mary Coble draws blood for ‘Deferral.’ (Photo courtesy Corcoran)

Internationally acclaimed queer performance artist Mary Coble will be doing a four-day show at the Corcoran Gallery of Art (500 17th St., N.W.) starting Wednesday and running through Aug. 10.

The performance, titled “Deferral,” addresses the Food and Drug Administration’s policy of refusing blood donations from “men who have sex with men.” It is also an installation, constructed in the Corcoran’s Atrium, with an anatomical theater formed by white hospital curtains.

“I will have a pint of blood drawn, and will then use that blood to make marks on the curtains to reference some of the campaign and political slogans surrounding the issue,” Coble says. “The men who are participating with me are gay men, so I am in the position of privilege because I can have blood drawn. They will be stitching using red thread to sew on the curtains to act as a stand-in for their blood, because their blood would not be considered by the FDA.”

The Corcoran’s hours are 10 a.m.-9 p.m. on Wednesday, and 10 a.m.-5 p.m. on Thursday, Friday, Saturday and Sunday. Admission is $10. For more information, visit corcoran.org.

01
Aug
2013

We need new AIDS drugs — fast!

Truvada, Gilead, gay news, Washington Blade

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

For those living with HIV and fortunate to have access to AIDS drugs, one of the scariest things they face is drug resistance. At some point, they know, their bodies will begin to resist their current drug regimens. This means their doctors will need to find out what’s happening, when to switch therapies and which drugs to switch to. Then you hope there is no “cross resistance” meaning that an entire class of drugs will be rejected. It’s a complicated and scary process.

Tragically, if they don’t switch or other drug regimens aren’t available or they’re resistant to other available drugs, as well, eventually they will succumb to AIDS and die. This is the harsh reality of living with HIV: Your options may eventually run out. A recent study estimates more than 76 percent of the U.S. HIV-positive population has some form of drug resistance.

But here is some good news. The Food and Drug Administration just approved a new antiretroviral called Tivicay. The once-daily drug is a class of antiretorvirals known as integrase inhibitors that actually block the virus from entering your immune systems T-cells. Tivicay is the first new treatment delivered by ViiV Healthcare in an HIV joint venture among GlaxoSmithKline, Pfizer and Shionogi in which GlaxoSmithKline is the largest shareholder, with a more than 75 percent stake.

Tivicay can be used to treat infected adults who have been taking other drugs or are new to treatment. So that is some good news in the fight against drug resistance:  Now there’s another treatment option available.

The approval of ViiV’s Tivicay is important because a number of companies already have or soon will get out of the HIV drug business. One is Roche, which developed the first protease inhibitor many believe saved hundreds of thousands of lives. Some rumors point to Abbott as the next.

Now here is really scary news: Drug resistance is on the rise worldwide, especially in Africa. A recent article in the Daily Nation reports that in Tanzania, around Lake Victoria, patients have stopped taking their HIV drugs. Why?  Side effects and drug supplies. In addition, there are reports other African countries have inconsistent HIV drug supplies.

It appears if clinics run out of one or more drugs, they switch their patients to new HIV drug regimens. “Abrupt switches of antiretroviral are threatening our health,” Samwell Chuma, an HIV patient in Tanzania, stresses, “and some new anti-HIV regimens are too strong for our weak bodies to withstand.” The sad truth is our brothers and sisters in Africa and the rest of the developing world are being given older drugs that many physicians in the United States and in other developed countries would hesitate to prescribe.  It’s all about access – unfortunately.

The sad reality is we can fight drug resistance only with different, that is, new drugs.

Now let’s look at the last time a new AIDS drug was approved before the emergence of Tivicay. I emphasize I mean new, and not existing combinations of older drugs contained in one daily pill.

This means we’ve already eliminated two recently approved drugs. One is Gilead’s drug Stribild, approved a year ago and known by some in the HIV community as the Quad. You can also discount their other combined-in-one pill drugs, Complera, approved in August 2011, and in Atripla, approved in 2006. Good treatments, but not a new drug.

A new drug, Edurant, produced by Janssen, went on the market in 2011. However, Edurant is not approved for patients already using antiretrovirals. Translation? If you are living with HIV now and on an AIDS drug regimen, then you are SOL as it relates to Edurant and, by the way, to some other antiretrovirals available now.

Clinical trials are now underway to explore the use of newly approved Tivicay in a once-daily, fixed dose combination that includes two drugs approved 15 years ago.  Looks like ViiV is going to take a chapter out of Gilead’s game plan:  Just combine older drugs into one convenient pill. This is the strategy that allowed Gilead to capture more than half the entire AIDS drug market, which is estimated in the tens of billions of dollars.

Sadly, the last time that Gilead actually had a new drug approved (again, I’m not including combination drugs in one pill that uses older existing drugs) was August of 2004. That’s almost 10 years ago. Clearly the trend, if you look at drug approvals over the past six years, is to combine several drugs into one convenient pill. But if we are going to survive this epidemic in the long term, it’s critical we have new drugs — and fast! It could mean the survival of millions of people living with HIV worldwide.

12
Sep
2013

Panel wants more research on MSM blood ban

blood, blood ban, gay news, Washington Blade

(Photo by Bigstock)

ORLANDO – A federal panel heard evidence last week to consider overturning a ban on blood bank donations by gay men – a holdover from the early days of the HIV virus and AIDS, Watermark reports.

But instead of suggesting the removal of the ban, members voted Dec. 5 to recommend funding continued research and establishing a “transfusion-transmissible infections monitoring system.”

The decision was a blow to advocates who have been pressing to overturn the 1985 FDA decision they say stigmatizes gay men and ignores advances in treatment and detection in the decades since, the Watermark report said.

The Department of Health and Human Services (HHS) Advisory Committee on Blood and Tissue Safety and Availability listened to research presentations Dec. 4-5 before voting on the recommendation. HHS Secretary Kathleen Sebelius will have the final say.

Although those infected with HIV typically develop antibodies within two-to-eight weeks of exposure, there are cases where it can take up to six months for those antibodies to show up, the CDC says.

The CDC has reported on examples in recent years of patients contracting HIV from blood transfusions, although it is extremely rare.

11
Dec
2013

Year in review: Home HIV tests become available

OraSure, OraQuick, HIV, HIV test, gay news, Washington Blade

(Photo courtesy OraSure Technologies Inc)

The U.S. Food and Drug Administration approved for the first time on July 3 an in-home, self-administered HIV test to be sold over the counter.

Known as the OraQuick In-Home HIV test, the test was developed by OraSure Technologies, Inc.

“The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods,” the FDA said in a new release.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”

The FDA says clinical studies of the test showed a 92 percent sensitivity rate, which means that of every 12 HIV-infected individuals tested with the kit, one negative result could be expected.

“A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the result,” the FDA said. “Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months.”

FDA officials noted that the OraSure in-home test is the first HIV test that allows users to learn their results at home immediately without interacting with a lab or medical professionals.

The officials said the new test’s potential for identifying large numbers of people who don’t know they are infected outweighs concern by some that people who test positive should have immediate access to counseling and medical advice.

Experts estimate that one-fifth of the people infected with HIV are unaware of their status and often contribute to the infection of others.

27
Dec
2012