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“PrEP: The Revolution That Didn’t Happen” Declares New AHF Ad

A new advocacy ad by the AIDS Healthcare Foundation (AHF) takes aim at the failure of pre-exposure prophylaxis (PrEP), the use of Gilead Sciences’ AIDS treatment Truvada to prevent HIV transmission in uninfected individuals, to catch on despite the fact that the powerful AIDS treatment medication has been approved by the Food and Drug Administration (FDA) for us as PrEP since July 2012 and that Gilead has spent millions to promote the drug directly to community groups and physicians.

In 2014, the Centers for Disease Control and Prevention (CDC) initially recommended that 500,000 gay men and other high risk individuals go on PrEP to prevent HIV infection. In late November of this year, the CDC raised that number to 1.2 million in November to also include other “high risk” people including intravenous drug users and heterosexual adults without HIV who have an HIV-positive partner or have multiple sexual partners. Today, only 21,000 people are currently on PrEP in the United States, according to Dr. Jonathan Mermin, the CDC’s Director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP).

AHF’s “PrEP: The Revolution that Didn’t Happen”, ad also calls out the CDC for directing funding away from proven STD/HIV prevention and treatment methods: “The failure of PrEP to catch on isn’t the biggest problem. The big problem is that CDC has abandoned promoting other prevention methods such as condoms.  STD rates, which indicate high levels of unprotected sex, are soaring across the board and yet budgets for the diagnosis and treatment of STDs are being cut. Funding for HIV testing, outreach and linkage to care are flat or declining.”

The ad can be viewed here and the full text is below:

PrEP: The Revolution that Didn’t Happen

In July 2012, the FDA approved Truvada for the prevention of HIV (PrEP). It was hailed by CDC and many activists as a prevention revolution. CDC recommended that 500,000 gay men take the drug which it recently raised to 1.2 million. Gilead Sciences, the maker of Truvada, has spent millions funding community groups to promote the drug and more money enticing doctors to prescribe it. Thousands of articles have been published about PrEP. Two and a half years later according to CDC only 21,000 people are on the drug in the United States. Any objective observer has to conclude that most patients don’t want to take Truvada and doctors are not recommending it.

 The failure of PrEP to catch on isn’t the biggest problem. The big problem is that CDC has abandoned promoting other prevention methods such as condoms.  STD rates which indicate high levels of unprotected sex are soaring across the board and yet budgets for the diagnosis and treatment of STDs are being cut. Funding for HIV testing, outreach and linkage to care are flat or declining.

We know that when people with HIV are treated and their virus is brought down to undetectable levels they are rendered non-infectious to others. Yet, in the United States only about 30% of the HIV infected population have their virus under control – a very bad situation.

AHF has made clear that we believe that PrEP is a good solution for individuals who have multiple partners and never use condoms. However, we do not believe that it is a proven public health solution. How long will it take for CDC to catch on to the failure of this strategy? In the meantime, our country is unprotected against the spread of HIV and other STDs. 

The editorial advertisement is scheduled to appear in the Florida Agenda and Washington DC’s Metro Weekly and Washington Blade this week, followed by placements in the South Florida Gay News, Frontiers (Los Angeles), Bay Area Reporter, Gay City News (New York City), Dallas Voice, and Georgia Voice the week of December 20th-26th.

“PrEP: The Revolution that Didn’t Happen” follows an August 2015 national editorial ad campaign entitled “Reaching Common Ground on PrEP” that outlined eleven suggested principles on PrEP and ran in the same publications.

PrEP-revolution-Frontiers-FP-FINAL_701x898

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What to Do If Your Provider Says “No” to PrEP

 

PrEP stands for Pre-Exposure Prophylaxis. It is a once-daily pill regimen that can help you stay HIV-negative. When taken as prescribed by a knowledgeable healthcare provider, PrEP has been shown to be more than 90 percent effective against contracting HIV.

But one in three healthcare providers has not even heard about PrEP, which means you could encounter some resistance if your clinician doesn’t have all of the facts. Here are some common misconceptions you might hear from a PrEP-skeptical provider and ways to address them using information from the Centers for Disease Control and Prevention (CDC)’s 2014 Clinical Practice Guidelines (you may even want to print it and bring it with you to your PrEP consultation/appointment):

PROVIDER SAYS: “I’m not an HIV specialist. You need to see an infectious disease doctor.”
YOU COULD SAY: “Actually, the CDC says primary care providers like you are fully equipped to prescribe PrEP. If you need more information, I know the Clinician Consultation Center offers clinically supported advice about PrEP to those who may need it. You can call them at 1-855-HIV-PREP. Can we re-visit this conversation after you’ve spoken to them?”

PROVIDER SAYS: “PrEP is only for [this type of person], and you’re not one of them.”
YOU COULD SAY: “While that may have been the conventional wisdom at one point in time, the CDC says anyone at substantial risk for contracting HIV may be a good candidate for PrEP. Can I walk you through some of the reasons I think PrEP might be right for me?”

PROVIDER SAYS: “We don’t know enough about the long-term effects of PrEP.”
YOU COULD SAY: “Multiple studies have shown PrEP to be safe and highly effective against contracting HIV. I appreciate your concern and certainly understand the need for regular check-ups. But for me, the benefits of PrEP far outweigh the risks.”

PROVIDER SAYS: “You don’t need PrEP. Condoms works just fine.”
YOU COULD SAY: “Nothing I’ve read suggests PrEP use and condom use are mutually exclusive. I plan to use PrEP in addition to the other safer sex strategies I’m currently using.”
YOU COULD ALSO SAY: “Condoms don’t work for me and my partner, hence my interest in PrEP. I’d also be interested in learning about other ways to prevent sexually transmitted infections, since I know PrEP only protects against HIV.”

PROVIDER SAYS: “PrEP is prohibitively expensive.”
YOU COULD SAY:  “Fortunately, my insurance plan covers the use of PrEP, so that won’t be a major factor in my decision-making.”
YOU COULD ALSO SAY: “I know there are several payment assistance programs out there to help offset the costs of the drug. Would you, or someone else in the office, be willing to help me navigate any necessary paperwork?”

Seeking advice from a knowledgeable healthcare provider is crucial as PrEP may not be right for everyone. Entering the conversation with an open mind and the proper information will go a long way toward getting the care that you need. Be sure to check out our other resources on talking to your provider about PrEP, while keeping in mind that if your provider doesn’t meet your needs, you’re always free to find one who will.

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How Sexual Addiction Treatment Fails When Working With Gay and Bisexual Men

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I thought I was done with the coming-out process, but I am coming out again, only this time on Psychology Today as a former sex-addiction therapist. Today I treat those struggling with out-of-control sexual behaviors much differently and more successfully with my current education and understanding about what sexual health is, and tailor it to each individual.

The reason? The longer I was in the field of sex addiction treatment the more I found both the label and many of the interventions antiquated, limiting and sometimes even harmful — especially when working with gay and bisexual men. Sex addiction treatment began to reveal itself to me as simplistic, moralistic and judgmental rather than truly diagnostic. The more I learned, the more I saw a number of problems embedded in the interventions within the model — negative messages of shame, erotophobia and homophobia — which were inextricably entwined in the treatment. Over the last 10 years I have become an AASECT (American Association of Sex Educators, Counselors and Therapists) certified sex therapist and supervisor, and have learned a great deal more about helping people with problematic sexual behaviors from an informed sexual-health model, which is lacking in the sexual addiction field.

Sex Addict or Homosexual?

I know of clients telling their therapist, “I would rather be a sex addict than a homosexual.” Some sex addiction therapists, especially those who have a religious influence to their work, admittedly believe that homosexuality is not an “authentic” identity, particularly for those who do not want it. Calling such sexual interests a “same-sex attraction” and an “acting out” of the client’s sexual addiction, these therapists then treat the client as a sex addict, and send him to Sexaholics Anonymous, which is overtly anti-gay. This type of sex-addiction treatment becomes, at times, the new “reparative therapy,” which is widely considered unethical and, in some states, illegal. It might be coming from a well intended therapist, however it is still treating same-sex attractions as pathology rather than exploring the various ways sexual orientation can manifest, or helping gay or bisexual men come out of their shame into their true sexual identity.

It implies that being sick and a sex addict is better than being a gay or bisexual man. I have had clients who are clearly homosexual, but because of their culture — such as Arab or Indian — they cannot come out and never will. I will never tell them that they are sex addicts or can change from gay to straight, or that they should manage their feelings because they are sick. Instead I help them to accept that they are homosexual, but don’t have to embrace the “gay lifestyle” or a gay identity — only if this is what they choose. This supports a position of sexual strength and health rather than pathology or sickness and keeping them ashamed.

Sex Addiction Treatment Should Not Endorse Sexaholics Anonymous

Sexaholics Anonymous (SA) remains on all the national sex-addiction websites as a resource, ultimately endorsing the program. SA is one of a number of 12-step fellowships dealing with recovery from compulsive sexual thinking and behavior, and it views LGBTQ behavior and relationship as pathological, unhealthy and not a true identity. It believes that sex should only be in the context of a marriage, which it defines as “one man and one woman.” While other fellowships may make no distinction between same-sex and opposite-sex behavior, SA explicitly defines sexual sobriety to exclude same-sex behavior.

Listing SA as a resource is not in keeping with values for an LGBTQ-affirmative sexual health affirmative therapy. It also in not in keeping with the values of any professional mental health organization such as National Association of Social Workers, American Psychiatric Association, or American Psychological Association, to name a few. It also goes against current scientific and professional views of human sexuality.

Because the label “sex addiction” contains the word “sex,” understanding and training is required for cultural competency of the various manifestations of the sexual and relationship lives of LGBTQ, and how we differ from our heterosexual counterparts. Currently it is glaringly lacking.

How I Became a Sex Addiction Therapist

I became a sex addiction therapist in the late 1980s. At the time, it seemed like a hopeful means to deal with out-of-control behaviors, especially in the gay male community. The specter of AIDS had descended on the gay community, and AIDS was considered in the broader culture to be divine judgment on gay sexuality. Gay men grew increasingly ashamed of their unbridled desires (the ’70s had seen an explosion of open sexuality in the gay community), and terrified that they would contract the disease, God’s punishment for their actions. I was one of them, and was grateful for the hope I could change my behavior.

Anything that didn’t involve heterosexual, normative, monogamous sexuality was seen as behavior having the potential to contract and spread HIV. Blame was falling on anyone having promiscuous sex outside of a committed and married relationship. Not surprisingly, numerous 12-step programs, like Sexaholics Anonymous, sprang up to help those who sought to change their behavior. Sex-addiction therapy became the go-to means to address the fears, and we frequently referred our clients to such groups.

However, gay men soon found that they were in the minority in these sex addiction settings, and were expected to think and act like their heterosexual counterparts — for instance having only monogamous relationships and taking time before having sex. Meeting someone and and having sex right away was common in the gay community. Such behavior was — and still is — labeled as a pathological and as a “courting disorder.” In the gay community it is also common to have open relationships, which is frowned upon by too many sex addiction therapists. BDSM and fantasy sex is quite open and normalized in the gay community, and yet sex addiction therapy targets those behaviors as problematic. What straight couples fight about around sexuality, gay male couples don’t. Thus sexual addiction lacks cultural competency on LGBTQ sexual behaviors and pathologizes non-heteronormative sexuality in general.

From Sexual Despair to Sexual Health

Referring a gay or bisexual client to Sexaholics Anonymous as part of a treatment plan is irresponsible and will only contribute to more despair. He is at risk for aligning himself with internalized homophobia by sitting in a room filled with rules and individuals believing that gay sex and gay relationships are wrong.

Instead, I refer gay and bisexual men to Sexual Compulsives Anonymous (SCA). This 12-step group was started by gay and bisexual men who needed a safe, judgment-free space to address their out-of-control sexual behaviors. On their national site they state, “SCA is a 12-Step fellowship, inclusive of all sexual orientations, open to anyone with a desire to recover from sexual compulsion.”

Clients come into therapy with many issues around sex. We need to help them manage their issues through the lens of appreciating this as part of themselves. It is important to see the distinctions between sexual health versus out-of-control behaviors. For example, understood in the context of the gay culture, when a gay man first comes out he often experiences a period of hypersexuality — a delayed gay adolescence, which is completely normal. It is inaccurate to label him a sex addict as he would be labeled in the SA model. Many straight men enjoy watching gay porn, and this speaks to the sexual fluidity of many straight men. Without a therapist understanding sexuality it can be easy to pathologize such behavior.

I am now revising an entire chapter I wrote on sexual addiction in my first book, 10 Smart Things Gay Men Can Do to Improve Their Lives. I am removing references to sex addiction treatment, and changing it to help gay men understand their sexual lives and problems from a strength-based, informed position. In my revisions I am referring more to the model and book, Treating Out of Control Sexual Behaviors: Rethinking Sex Addiction, by Doug Harvey-Braun and Michael Vigorito, focusing on the treatment of men struggling with problematic sexual behaviors, and using a strength-based and sex-positive approach.

I feel it is the responsible thing to do.

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Attention LGBT Travelers: A Queer Version Of Airbnb Is Here

 

Traveling as a lesbian, gay, bisexual or transgender (LGBT) person comes with a certain amount of risk — especially when traveling on a global level.

This level of risk is intensified when LGBT travelers stay in unfamiliar locations, or have to rely on apps like Airbnb to book rooms in stranger’s homes or spaces. For this reason, a new app called Wimbify aims to help queer people find safe spaces to lay their heads at the homes or spaces of LGBT individuals, families or allies while abroad.

“When you choose to spend your holiday in an apartment rented online, the risks are right around the corner,” Alessio Virgili of Wimbify told The Huffington Post. “For an LGBT traveler, these risks increase. [What] if the person who is hosting doesn’t like the idea of an LGBT person in their house, or even an LGBT couple or family?”

“Besides avoiding feelings of unease or discrimination, being hosted by an LGBT or LGBT-friendly host makes it easier to socialize and [gain] knowledge of the local LGBT community, especially in destinations where gay life is often lived underground and it’s difficult to find information and to find yourself safe.”

Particularly in parts of the world where being LGBT still comes with heavy consequences — some of which can be life-threatening — apps like Wimbify can serve a crucial function.

Want to see more? Head here to check out the app and safe travels this holiday season!

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HRC Releases 2016 Buyer’s Guide to Businesses Supporting LGBT Workplace Inclusion

Just in time for Black Friday and the holiday shopping season, the Human Rights Campaign (HRC) Foundation has released its popular consumer guide to hundreds of American companies rated on their LGBT-inclusive policies and practices.

The Buying for Workplace Equality guide, first issued more than a decade ago, provides invaluable consumer information based on company scores reported in HRC’s annual Corporate Equality Index (CEI), as well as HRC-researched data on additional well-known companies and their brands.

Through the CEI, the HRC Foundation proactively rates Fortune 500 companies and top law firms on LGBT-inclusive workplace policies and practices, and urges smaller companies to also participate. This year, new CEI criteria required that all participating  companies extend explicit LGBT non-discrimination protections to their employees worldwide.

“Our annual Buying for Workplace Equality guide provides quick, user-friendly help in selecting everything from groceries to cars with LGBT equality in mind,” said Deena Fidas, Director of HRC Foundation’s Workplace Equality Program. “With the LGBT community’s buying power in the U.S. edging close to $900 billion, it just makes good business sense to embrace LGBT workplace inclusion.  Every year we hear from members of  the LGBT community and many other fair-minded consumers who want to choose brands that align with their priorities of workplace fairness. They check the buyer’s guide to ensure that their dollars go to businesses that support equality.”

The Buying for Workplace Equality guide sorts businesses by sectors, assigning them a score ranging from zero to 100 based on LGBT workplace equality, as measured by the CEI and HRC-researched data. Those include:

  • Apparel & Accessories
  • Banking & Finance
  • Food & Beverage
  • Home & Garden
  • Restaurants
  • Technology

Businesses and their products are divided based on their CEI rating into red, yellow and green categories so that consumers can easily determine which brands support LGBT workplace equality:

  • Green (80-100): Businesses/brands with the highest workplace equality scores.
  • Yellow (46-79): Businesses/brands that have taken steps toward a fair-minded workplace and receive a moderate workplace equality score.
  • Red (0-45): Businesses/brands that receive our lowest workplace equality scores

The new guide includes more than 570 companies–449 of those are rated in the CEI, and an additional 121 have been independently researched by the HRC Foundation. A total of 5,496 affiliated businesses and brands are featured in this year’s report. Companies independently researched have declined invitations to actively participate in the CEI; their scores are based on publicly-verifiable information.

Note: Companies with scores listed in italics have not responded to the survey despite repeated invitations. They have been assigned an unofficial, estimated score based on publicly-available information that HRC has collected.

HRC welcomes new relationships with businesses that have not responded to attempts to gather information on LGBT workplace policies and programs.

For more information on the Buying for Workplace Equality guide and to search by company category, go online to www.hrc.org/buyersguide.

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New Trans Immigrant Leadership Initiative Launched

 

Honor Trans Immigrant LivesOn the National Day of Action to End Trans Detention, Transgender Law Center, along with members of the #Not1More campaign, announced a new national initiative, Honor Trans Immigrant Lives, to build leadership and capacity within transgender immigrant communities. While there has been significant work to end the detention and abuse of transgender people being held in immigration custody, there have not been coordinated, national efforts to build trans immigrant leadership within this work or support trans immigrants post-detention.

“For too long, transgender immigrants have been ignored and under-resourced by both LGBT and immigrant rights movements,” said Isa Noyola, Program Director at Transgender Law Center. “This is a community of incredible courage – women who, minutes after being freed from detention centers, join actions demanding the release of their sisters still inside. This initiative recognizes the critical need to honor trans immigrant lives and, just as importantly, resource trans immigrant leadership.”

The launch of the Honor Trans Immigrant Lives Initiative comes during #Not1More’s National Week of Action on the Anniversary of DAPA and on the eve of Transgender Day of Remembrance, a day that recognizes the extreme rates of violence and murder faced by transgender people, particularly transgender women of color. As part of the Transgender Day of Resilience Art Project, coordinated by Forward Together, artist Mojuicy created a poster representing the initiative’s work for Transgender Law Center. The poster seeks to reframe conversations around trans immigrant women, so often focused on death and violence, to instead uplift trans immigrants’ power, resilience, and collective strength.

The initiative will build on work that has been developing over the past few months, including the first-ever national call for transLatinas on immigration and a retreat for transgender Latina immigrant leaders in early November. For today’s #Not1More Deportation National Day of Action, organizations across the country are holding rallies today to #freeChristina and all trans immigrants from ICE detention. Christina Lopez is a 35-year-old transgender woman who has been in immigration detention for a year and a half and who has Hepatitis C, but she has been the denied medical attention she urgently needs.

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Twitter Bans On-Site Blood Drives As Long As Gay, Bisexual Employees Can’t Participate

Twitter has taken heat for its lack of racial diversity, but it has taken a stand in support of its LGBT employees by ending on-site blood drives until the Federal Drug Administration lifts a decades-old ban that prevents healthy gay and bisexual employees from participating.

Since 1983, the FDA has prevented men who have had sexual relations with other men to donate blood. The policy was put in place in response to the nation community’s AIDS crises in the 1980s, but more recently, that policy has been criticized for being unnecessary and discriminatory.

“These are the only policies that the FDA has based on a person’s identification and not any type of risky behavior that they’re engaged in,” said Jim Halloran, Twitter’s Associate Manager of Sales Operations and  President of TwitterOpen, Twitter’s LGBT employee resource group. “Twitter took a very bold stance.”

Twitter decided to take a stand against this policy after a gay employee was turned away from a blood drive being held at its headquarters. That employee filed a complaint with human resources and Twitter decided to no longer host blood drives onsite after April 2015, the company told the International Business Times on Wednesday.

“We made the choice to take a company stand against some of our employees being turned away from donating blood and will channel our efforts into education about this issue until this unnecessary and discriminatory policy is changed,” said Brian “Skip” Schipper, Twitter’s Vice President of Human Resources and the Executive Sponsor of TwitterOpen.

Twitter shared the news after being named one of the “Best Places to Work for LGBT Equality” by the Human Rights Campaign on Wednesday, an indication that could help the company in recruiting talented candidates from the LGBT community. Besides boycotting blood drives, Twitter has also filed a public comment with the FDA. TwitterOpen has also promoted a petition to “stop discriminating and screen male blood donors equally.”

Though the FDA proposed altering the lifetime ban to allow gay and bisexual men who have abstained from sex with another men for at least 12 months to donate blood, Twitter plans to continue boycotting until the restriction is completely removed and replaced by one determined by risky behavior not sexual identity.

“We strongly urge the FDA to reconsider this draft rule, remove the restrictions on donations from MSM [men who have sex with men], and redraft safety regulations that are based on legitimate behavioral risk factors,” said Colin Crowell, Twitter’s Vice President of Global Policy, in a letter submitted to the FDA in July.

Twitter Inc.’s Timeline | FindTheCompany

The FDA said it “has been carefully reviewing and considering all comments in finalizing the guidance” for the change to its policy on gay and bisexual men. The agency has not committed to a specific timeline for when the change may go into effect.

The Human Rights Campaign, an LGBT civil rights advocacy group, and others argue that research shows that three month deferral is adequate time to protect the blood supply. According to the National Institute of Health, that is the amount of time it takes for HIV antibodies to be detected by a test.

“We want our blood supply to be safe, and the good news is that the science shows we can have a safe blood supply without having a discriminatory policy,” said David Stacy, government affairs director at Human Rights Campaign. “The terrible thing is when a gay man goes to give blood and suddenly is told ‘We’re not accepting your blood.’ That can be really hurtful.”

Stacy said that to his knowledge, Twitter is the only public tech company to publicly take a stand against the FDA’s policy. Having a major company like Twitter boycott the FDA’s practices is helpful, as it draws attention to the issue.

“There are times when there is a shortage of blood and it is very important that people who can donate [do] donate,” Stacy said. “But right now in the U.S., there is an ample supply of blood, so people taking a stance makes sense.”

In August, Twitter disclosed that its workforce is 34 percent women, four percent Hispanic and just 2 percent African-American. The company has not previously disclosed how many of its employees are LGBT, but  its stance on the FDA policy was commended by members of that community.

Twitter is looking at how it can use its influence “to really make sure that we’re making the best decisions for our employees, helping them out not only inside the office but in the life that they’re leading outside the four walls as well,” Halloran said.

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Sexually Transmitted Disease Rates Reach Record High In U.S.

A U.S. sexually transmitted diseases epidemic is increasing and the most common infection, chlamydia, has risen to record levels, government officials say.

Reported cases of chlamydia, gonorrhea and syphilis all increased in 2014. Chlamydia cases had dipped in 2013, but last year’s total of more than 1.4 million — or 456 cases per 100,000 — was the highest number of annual cases of any condition ever reported to the federal Centers for Disease Control and Prevention. The chlamydia rate was up almost 3 percent from 2013, the CDC reported Tuesday.

Sexually transmitted diseases are among more than 70 diseases that are reportable to the CDC, including measles, chickenpox and tuberculosis. Flu is reported differently, by hospitalizations.

“America’s worsening STD epidemic is a clear call for better diagnosis, treatment, and prevention,” said the CDC’s Dr. Jonathan Mermin.

Gonorrhea cases totaled 350,062, up 5 percent from 2013, and the most contagious forms of syphilis jumped 15 percent to 20,000. As in previous years, the syphilis increase was mainly in gay and bisexual men.

Most gonorrhea and chlamydia infections were in 15- to 24-year-olds, an ongoing trend. Both can cause infertility in women but can be treated with antibiotics. They often have no symptoms, and while yearly screening is recommended for sexually active women younger than 25, many don’t get tested and infections go untreated, the CDC said.

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NIH to Fund First Large-scale Trial for Heart Disease Prevention Among People With HIV

 

Studies have shown that individuals with HIV are 50–100 percent more likely to develop cardiovascular disease (including heart attack and stroke) than individuals without HIV; however, more research is needed to determine if use of statins is the answer.  The National Institutes of Health (NIH) is now funding the largest cardiac prevention trial in HIV, called REPRIEVE, a Randomized Trial to Prevent Vascular Events in HIV.

This landmark study is the first large-scale randomized clinical trial to test a strategy for heart disease prevention among people living with HIV.  The REPRIEVE Clinical Trial is evaluating whether a daily dose of pitavastatin, a statin used to lower cholesterol and prevent heart disease, lowers the risk of heart-related disease among people living with HIV.

The REPRIEVE trial will include 6,500 participants and will be conducted at approximately 100 clinical research sites, primarily in the United States. The trial will be conducted through the AIDS Clinical Trials Network, as well as other NIAID sites and established clinical research sites. REPRIEVE scientists including Dr. Steven Grinspoon (Harvard Medical School), Dr. Pamela Douglas (Duke University School of Medicine), Dr. Udo Hoffmann (Harvard Medical School) and Dr. Heather Ribaudo (Harvard School of Public Health) are internationally recognized experts in the fields of HIV medicine, cardiology, endocrinology, radiology and biostatistics.

“An ideal intervention to prevent cardiovascular disease in HIV would affect both conventional lipid and HIV specific immune mediators of cardiovascular disease and would have minimal risk,” according to Dr. Grinspoon. “Statin therapy uniquely meets these criteria.”

For more information on the trial go to reprievetrial.org

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New Single-tablet HIV Treatment Wins FDA Approval

The US Food and Drug Administration have approved a new single tablet as a complete treatment for the treatment of HIV-1 infection in people aged 12 years and over.

The new single-tablet HIV drug contains a new form of the powerful HIV inhibitor tenofovir.

The new treatment, called Genvoya, from Gilead Sciences, is a fixed-dose combination of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

It is intended for patients aged 12 and over, weighing at least 35 kg (77 lbs) and who have never been treated for HIV before, or for infected adults whose HIV is currently suppressed.

The drug was tested against other HIV treatments approved by the Food and Drug Administration (FDA) in four clinical trials involving a total of 3,171 participants. Results showed that it reduced viral loads and was comparable to other treatments.

Genvoya contains a new version of tenofovir – a powerful HIV inhibitor – that has not been approved before. Gilead say that because the new version (called TAF) enters cells – including HIV-infected cells – more efficiently than the previous version (TDF), it can be given at a lower dose that results in 91% less tenofovir in the bloodstream.

The new drug was developed to reduce side effects, and the trial results show it appears to be associated with less kidney toxicity and reductions in bone density than previously approved drugs containing tenofovir.
Suitable for patients with moderate kidney impairment

The FDA note that while Genvoya is not recommended for patients with severe kidney impairment, those with moderate impairment can take Genvoya.

However, the US regulator also comments that “patients receiving Genvoya experienced greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the studies.”

The drug’s Boxed Warning says it can cause lactic acid to build up in the blood and lead to severe liver problems, both of which can be fatal.

The most common side effect is nausea, and serious side effects include new or worsening kidney problems, reduced bone mineral density, fat redistribution and changes in the immune system.

The warning also says Genvoya should not be given with other antiretroviral drugs and may interact with a number of commonly used medications.

Dr. Edward Cox, director of antimicrobial products in the Center for Drug Evaluation and Research at the FDA, said on Thursday:

“Today’s approval of a fixed-dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection.”

Estimates suggest around 1.2 million Americans aged 13 and over know they have HIV, and more than 150,000 others are infected but do not know it. In the last 10 years, the annual number of new HIV infections has remained relatively stable.

HIV-1 is the predominant strain of HIV that causes the vast majority of HIV infections worldwide. When people refer to HIV, they usually mean HIV-1.

Earlier this year, Medical News Today reported on a study that suggests drugs already being tested for the treatment of cancer could reawaken dormant HIV in cells of patients treated with antiretroviral drugs to allow complete eradication of the virus.

Written by Catharine Paddock PhD

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