Truvada receives FDA approval for the prevention of HIV

Today, the FDA approved the medication Truvada for use in lowering the risk of HIV infection in individuals who are at high risk of infection. According to a press release from the FDA, “Truvada is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. Truvada is the first drug approved for this indication.”

The FDA said Truvada for PrEP should  be used as part of a comprehensive HIV prevention plan that includes risk reduction counseling, consistent and correct condom use, regular HIV testing, and screening for and treatment of other sexually-transmitted infections, stating that “Truvada is not a substitute for safer sex practices.”

Currently, Truvada (a fixed dose combination of emtricitabine/tenofovir disoproxil fumarate) is one of the most widely prescribed HIV medications in the country, combined with other antivirals to create a treatment regimen. Truvada now carries a Boxed Warning on its drug label alerting health care professionals and uninfected individuals that Truvada for PrEP must only be used by people confirmed to be HIV-negative before being prescribed the drug and tested at least every three months during use to reduce the risk of developing drug resistant HIV-1 variants. Both the antiviral and the PrEP dose is one pill taken once daily.

Truvada maker Gilead Sciences worked with the FDA to create a Risk Evaluation and Mitigation Strategy (REMS) for Truvada PrEP. The REMS focuses on a prescriber training and education program in counseling and managing individuals who are taking or considering Truvada for PrEP, looking at the important elements of a comprehensive HIV prevention strategy, the importance of adhering to the recommended daily dosing regimen, and the serious risks of taking Truvada for PrEP if already infected with the virus or of becoming infected with HIV while taking it. 

The FDA based its approval on the efficacy and safety demonstrated in two large, randomized, double-blind, placebo-controlled clinical studies, iPrEx and Partners PrEP.

As a condition of approval, Gilead Sciences is required to collect viral isolates from individuals who become infected with HIV while taking Truvada and evaluate them for the presence of drug resistance. The company is also required to collect data on women who become pregnant while taking Truvada for PrEP and to conduct a study evaluating drug adherence and its relationship to adverse events, risk of HIV infection, and the development of drug resistance in people who become infected.

“Today’s decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies and nearly 20,000 trial participants around the world, and Gilead is proud to have been a partner in this effort,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “This advancement in the field of HIV prevention was made possible due to the leadership and commitment of the FDA and the Department of Health and Human Services to reduce the number of new HIV infections in the United States and worldwide.”

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Researchers at Georgetown University Medical Center appear to have solved the mystery of why some patients infected with HIV, who are using antiretroviral therapy and show no signs of AIDS, develop serious depression as well as profound problems with memory, learning, and motor function. The finding might also provide a way to test people with HIV to determine their risk for developing dementia.

They say the answer, published in the July 11 issue of the Journal of Neuroscience, may ultimately lead to a therapeutic solution that helps these patients as well as others suffering from brain ailments that appear to develop through the same pathway, including those that occur in the aged.

“We believe we have discovered a general mechanism of neuronal decline that even explains what happens in some elderly folks,” says the study's lead investigator, Italo Mocchetti, PhD, professor and vice chair of the department of neuroscience at Georgetown University Medical Center. “The HIV-infected patients who develop this syndrome are usually quite young, but their brains act old.”

The research team found that even though HIV does not infect neurons, it tries to stop the brain from producing a protein growth factor called mature brain derived neurotrophic factor (mature BDNF). Mocchetti says mature BDNF acts like food for brain neurons and a reduced amount results in the shortening of the axons and their branches that neurons use to connect to each other. When they lose this connection, the neurons die.

Mocchetti believes that HIV stops production of mature BDNF because that protein interferes with the ability of the virus to attack other brain cells. It does this through the potent gp120 envelope protein that sticks out from the viral shell—the same protein that hooks on to brain macrophages and microglial cells to infect them. “In earlier experiments, when we dumped gp120 into neuronal tissue culture, there was a 30-40% loss of neurons overnight. That makes gp120 a remarkable neurotoxin,” he explained.

This study is the product of years of work that began when Mocchetti and his colleagues were given a grant from the National Institutes on Drug Abuse to determine whether there was a connection between the use of cocaine and morphine, and dementia. When they found that it was the virus that was responsible for the dementia, not the drugs, they set out to discover how the virus was altering neuronal function.

Their scientific break came when the researchers were able to study the blood of 130 women who were enrolled in the 17-year-old, nationwide WIHS (Women's Interagency HIV Study), which has focused on the effects of HIV in infected females. In one seminal discovery, Mocchetti and colleagues found that when there was less BDNF in the blood, patients were at risk of developing brain abnormalities. He published this finding in 2011 in the May 15 issue of AIDS.

In this study, Mocchetti, Alessia Bachis, PhD, and their colleagues studied the brains of HIV-positive patients who had developed HIV-associated dementia before they’d died. They also found that neurons had shrunk, and that mature BDNF had substantially decreased.

Normally, neurons release a long form of BDNF known as proBDNF, and then certain enzymes cleave proBDNF to produce mature BDNF, which then nurtures brain neurons. When uncut, proBDNF is toxic, leading to “synaptic simplification,” or the shortening of axons.

“HIV interferes with that normal process of cleaving proBDNF, resulting in neurons primarily secreting a toxic form of BDNF,” Mocchetti explains. “The link between depression and lack of mature BDNF is also known, as is the link to issues of learning and memory. That's why I say HIV-associated dementia resembles the aging brain.”

The findings suggest a possible therapeutic intervention, he adds. “One way would be to use a small molecule to block the p75NTR receptor that proBDNF uses to kill neurons. A small molecule like that could get through the blood-brain barrier.

“If this works in HIV-dementia, it may also work in other brain issues caused by proBDNF, such as aging,” Mocchetti adds.

The finding also suggests that measuring proBDNF in HIV-positive patients may provide a biomarker of risk for development of dementia.

“This finding is extremely important for both basic scientists and physicians, because it suggests a new avenue to understand, and treat, a fairly widespread cause of dementia,” Mocchetti says.

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Needle Exchange Survey Results Available

Results of the 2010 National Survey of Syringe Exchange Programs are now available  by clicking here. The survey is the only source of national data on syringe exchange in the U.S.

The survey was made possible with the support of Beth Israel Medical Center, the American Foundation for AIDS Research (amfAR), and the Elton John AIDS Foundation.

This is also a reminder that the 2011 National Syringe Exchange Survey is currently underway. The survey is used to inform policy makers and advocates, and is especially important in the effort to reverse the ban on federal funding for syringe exchange.  The survey can be found here.

Not only is this an opportunity to make drug user health a priority, but Beth Israel will send you a $75 incentive payment when you submit your survey.

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Berry Premieres Blog on Huffington Post

Positively Aware editor Jeff Berry has joined other AIDS activists and journalists such as The Body’s Kellee Turrell, the AIDS Foundation of Chicago’s David Munar, and others in becoming a blogger published by The Huffington Post.

In advance of the upcoming AIDS 2012 World AIDS Conference, Berry wrote “Reflections from an Epidemic: Carrying the Torch to AIDS 2012.” In it, he talks about the significance of this being the first conference to be held in the U.S. since President Obama lifted the travel ban on HIV-positive people, his anticipation of such events as displays of the AIDS Memorial Quilt, a planned march and demonstration,  the performance of the Tony Award-winning play The Normal Heart, as well as the many global leaders in AIDS policy, advocacy, and treatment advances that will be presenting at the conference.

As a long-time activist himself, Berry also looks forward to a necessary re-dedication of the efforts of advocates to keep fighting against the disease. As he puts it, “I will continue to fight for all of those who are no longer with us, for those who are still with us but who have no voice, and wage war against the apathy and complacency around us that makes our work at times an uphill battle.”

Click here to read the entire blog and stay tuned for Berry’s live coverage of the conference, along with other PA staff, on Facebook, Twitter, and in the September/October issue of Positively Aware.

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Red Ribbon Show Benefits Camp Starlight

On July 8 at the Southside Speakeasy & Dance Pub in Salem, Oregon, there was a packed house for the 5th annual Red Ribbon Show to raise money for Camp Starlight, an Oregon summer camp for children affected by HIV/AIDS, a program of Cascade AIDS Project.

The event included a drag and variety show featuring performers from across the Northwest, as well as silent and live auctions and a raffle. This year's event also received support from openly HIV-positive celebrities Jack Mackenroth (Project Runway), Olympian Greg Louganis, who donated autographs for the auction, and Styx bassist Chuck Panozzo, who sent in a signed electric guitar.

The Red Ribbon Show, established in 2007 by former Mr. Gay Oregon Jonathan Reitan, has raised nearly $20,000 for a variety of HIV/AIDS organizations and $8,600 was raised this year for Camp Starlight.

“The Red Ribbon Show is not just about raising money, it is about encompassing the entire umbrella of HIV/AIDS and how it affects our communities,” said Reitan. “It is about awareness, it is about prevention, it is about support. I am only one voice, but together we can and will make a difference.”

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Frank Finally Marries

Democratic Representative Barney Frank tied the knot with his longtime partner Jim Ready on July 7, becoming the first member of Congress to enter into a same-sex marriage. 

The wedding, which was held in Newton, Massachusetts, and officiated by Governor Deval Patrick, was attended by 300 family and friends, according to a statement from Frank’s office.

Frank, who was the first openly gay member of Congress, announced in November 2011 he would retire after 16 terms in the House. In January, he announced his plans to marry Ready in his home state, which is one of six to have legalized same-sex marriage. 

“I think it’s important that my colleagues interact with a married gay man,” Frank had said in an interview with New York magazine. “I do think, to be honest, if I was running for re-election, I might have tried to put the marriage off until after the election, because it just becomes a complication,” Frank added. “But I did want to get married while I was still in office.”

Frank had joked before the wedding that President Obama would not be invited citing security concerns. “If he and Michelle wanted to come, I would be delighted and honored to have them, but he will bring the Secret Service,” Frank said in January. “I don’t want to be accused of having shut down the entire region for a five-mile radius on a holiday weekend.”

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Legislation Watch

Fallout from the Supreme Court’s ruling on the ACA continues. The vote on July 11 represented the House’s 33rd attempt to kill the Affordable Care Act (ACA) either wholly or in part. As predicted, this repeal effort, like all the others, passed the House, this time with a 244-185 vote, including five Democrats from “vulnerable” districts who voted for it. The five hours of “debate” over two days, along with the vote itself, have been called “political theatre,” since the Senate will not bring the bill up for a vote and even if they did and it passed, President Obama has said he’d veto it. But there was a new twist of hypocrisy added to the reports on this vote.

Repealing the health care law would let members of Congress keep their government-subsidized insurance coverage after they retire—a benefit they lost under Republican Senator Chuck Grassley’s amendment to the ACA, which kicked members of Congress and their aides out of the healthcare program for federal employees. Instead, lawmakers and staff would have to get coverage through the insurance exchanges created by the healthcare law. Grassley, displaying the courage to go against his party, said it ensures that lawmakers live under the same rules as their constituents.

“The message to grassroots America is that health care reform is good enough for you, but not for us,” Grassley said last year, defending his amendment.

Before the Affordable Care Act became law, members and their staffs bought insurance through the Federal Employees Health Benefit Program (FEHBP). They would return to the FEHBP if the law is repealed.

The FEHBP allows government employees to keep their policies after they retire. People who get insurance through a private employer, however, often lose their coverage when they lose their job or change jobs, yet another problem that would be solved by single-payer health care.

The FEHBP is widely regarded as one of the country’s more successful health care programs. Federal employees can choose from a range of plans that meet certain minimum standards. The federal government subsidizes its employees’ coverage, just like any other large employer.

Insurance companies are eager to participate in the FEHBP because it offers them access to a large pool of potential customers, just as the individual mandate and the insurance exchanges under the new law are meant to do.

Also ACA-related, HR 6097, the Religious Freedom Tax Repeal Act, was introduced by Republican James Sensenbrenner Jr. on July 10. The ACA requires that most employers cover birth control without a co-pay for employees. Under the GOP bill, employers that object to birth control for religious reasons can refuse to cover it without facing financial penalties from the government.

Sensenbrenner's bill would erase the taxes faced by employers who choose not to cover certain healthcare benefits “by reason of adherence to a religious belief or moral conviction.” Those who oppose the bill, and others like it in the past, have argued that the broad criteria of “moral conviction” could lead employers to deny prescription drug coverage to those with HIV or other STIs, coverage to same-sex couples in states where gay marriage or civil unions are legal, and drug and alcohol abuse treatment to addicts.

Though alarming scenarios have been presented of churches and religious schools and hospitals being “taxed out of business,” the fact is that churches and houses of worship have always been exempt from the mandate altogether, while religious-affiliated institutions don’t have to pay for the coverage through their own plans—their employees will instead get contraception directly from the insurer, still without a co-pay.

No co-sponsors have been added to any of the bills we’re keeping an eye on. There are 40-some days left in this Congress in which they could actually get things done, but if they insist on spending all their time on trying to defeat the ACA and denying women their reproductive rights, it seems unlikely that one single job will be created or one dollar added to the economy due to Congressional achievement. No wonder their approval rating is nearing single digits.

Are you registered to vote? Do you live somewhere where politicians are trying to take away voting rights or where millions are being spent trying to buy your vote? Show them you won’t be stopped or bought. Register. Do your homework. Find out the facts. Vote. There is no excuse not to.

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