HIV pill could cut infections in gay, bisexual men by a third

From Reuters Health

The rate of new HIV infections among gay and bisexual men could drop by up to a third over the next decade if enough eligible men take a drug that protects against the virus, researchers estimate.

According to the U.S. Centers for Disease Control and Prevention, eligible gay and bisexual men meet any of three criteria: they have unprotected anal sex in a monogamous relationship with a partner not recently tested for HIV, or they have unprotected anal sex with a partner outside of a monogamous relationship or they have any anal sex with someone who is HIV positive.

Getting the drug, known as Truvada and manufactured by Gilead, to 40 percent of high-risk men would prevent 1,162 infections among every 100,000 gay and bisexual men over 10 years, researchers estimate in The Journal of Infectious Diseases.

The daily pill is a combination of two antiretroviral drugs that work to keep the human immunodeficiency virus (HIV), which causes AIDS, from reproducing in the body. Approved by the U.S. Food and Drug Administration in 2012, Truvada is often just referred to as PrEP, which stands for pre-exposure prophylaxis.

“We were all interested in estimating the public health impact and efficiency of PrEP,” said Samuel Jenness, the study’s lead author from Emory University in Atlanta.

Jenness and colleagues point out that PrEP is 92 percent effective in preventing HIV infections.

To see how PrEP might change the number of new infections over the next decade, the researchers used a mathematical model that took into account HIV transmission rates among men who have sex with men and the CDC guidelines.

They ran several scenarios through the model and found that getting PrEP to 40 percent of eligible men – and having 62 percent stick to the daily regimen – would avert 33 percent of expected infections among all gay and bisexual men in the U.S. over the next decade, compared to a scenario in which the drug was not available.

Getting PrEP to 10 percent of eligible men would avert about 11 percent of expected new infections, and increasing coverage all the way to 90 percent would avert about half of cases, the researchers calculated.

In a scenario where 40 percent of eligible men take PrEP, the researchers say, having 25 men taking the pill every day would prevent one new HIV infection.

Counseling men on adhering to the daily pill would maximize the public health investment by decreasing the number of men needed to treat to prevent one infection, they add.

Jenness told Reuters Health that currently, 5 percent to 10 percent of gay and bisexual men take PrEP.

In an editorial published with the study, an HIV expert said he’s not sure it’s actually possible to get 40 percent of eligible gay and bisexual men to take PrEP.

“However, PrEP studies from the United States, the United Kingdom, Canada, France, and other high-income countries are showing that those who seek out PrEP have substantial HIV risk and adhere well, resulting in near elimination of HIV acquisition,” writes Dr. Jared Baeten, of the University of Washington in Seattle.

Those results show the men currently starting PrEP are good candidates, he said.

SOURCE: bit.ly/29H7FNb The Journal of Infectious Diseases, online July 14, 2016.

Gay men follow HIV prevention regimen, if MDs prescribe it

From Reuters

Out of more than 1,000 gay and bisexual men surveyed, only 83, or fewer than one in 10, reported that they use HIV pre-exposure prophylaxis (PrEP).

But 42 percent of those who do use it said they had not skipped a single dose in the previous 90 days, and only 6 percent had skipped more than two doses per week, the investigators reported at the annual meeting of the Society of Behavioral Medicine in Washington, DC.

Docs need to prescribe PrEPThe lesson for care providers is that men are willing and able to take a daily pill, so it is important to talk to those who could benefit and increase prescription rates, study leader Jeffrey Parsons, a professor of psychology at Hunter College, City University of New York, told Reuters Health by email.

“The majority of gay men who are . . . good candidates for PrEP are not on the medication, and many haven’t spoken to their medical providers about PrEP. We need to get conversations going, and in general promote more open dialogue between doctors and patients regarding sexual health,” Parsons said.

The U.S. Centers for Disease Control has guidelines to help healthcare providers determine who is an appropriate candidate for PrEP with safer sex practices and Truvada, a pill made by Gilead that contains the antiviral drugs emtricitabine and tenofovir.

Read the full article.

Meet the man who got HIV while on daily PrEP

From POZ.com

Ever since July 2012, when the FDA approved Truvada as PrEP, a pre-exposure prophylaxis to prevent getting HIV, its success rate has been, well, perfect. In fact, not a single person adhering to the daily regimen has ever tested HIV positive—and that includes everyone in clinical trials and studies, and the more than 40,000 people taking Truvada as PrEP in the United States. But PrEP researchers, like most scientists, rarely speak in absolutes and guarantees; they’ve acknowledged that, under rare circumstances, an infection is feasible. Last week, that hypothetical situation became a known reality.

HIV pos while on daily PrEPOn February 25 at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, David C. Knox, MD, an HIV specialist at the Maple Leaf Medical Clinic in Toronto, presented data on a patient who, after two years of good PrEP adherence, tested HIV positive (for more on that, read this article by POZ’s Benjamin Ryan).

In Knox’s presentation, his patient remained anonymous, but many of us in the PrEP and HIV communities had followed his seroconversion story in real time as he posted about it last May in the Facebook group PrEP Facts: Rethinking HIV Prevention and Sex, in which he was an active member. Since then, Joe—as he prefers to be called here—dropped off the discussion boards. I had kept his information and interviewed him earlier this year for a potential POZ feature. At that time, the 44-year-old was excited to put 2015 behind him (more on that later). We chatted about gentrification in Toronto’s “gay village,” and he described himself as a “foreigner” whose family had lived in Kuwait and Denmark before moving to Canada when he was 11, experiences that resulted in his speaking several languages and working as an international flight attendant for 14 years. Now employed at a telecommunications giant, Joe sounded optimistic about his future job prospects and he was devoting energy to the new love of his life: Oliver, a Lhaso Apso-Maltese-Yorkie mix. Importantly, Joe had acclimated to a new HIV regimen, taking his meds each morning, and his viral load had remained undetectable.

Read the full article on POZ.com.

High rates of STIs among PrEP users

From aidsmap.com

Participants taking tenofovir/emtricitabine (Truvada) for pre-exposure prophylaxis (PrEP) continued to have high rates of sexually transmitted infections (STIs) in two US PrEP demonstration projects, according to a pair of reports at the Conference on Retroviruses and Opportunistic Infections (CROI 2016) last month in Boston. Semi-annual STI testing missed many cases, leading researchers to suggest that gay men on PrEP could benefit from screening every three months.

One of the most common concerns surrounding PrEP is the high rate of STIs seen among users. There is little evidence that PrEP actually causes an increase in STIs, but gay and bisexual men at risk for HIV already have high STI rates, and many PrEP users are likely to be already having, or wish to have, sex without condoms.

As Sheena McCormack, lead investigator for the English PROUD study, explained at a CROI symposium on innovations in PrEP, “the pre-existing trajectory of rising STIs [among men who have sex with men] is carrying on, but PrEP means HIV doesn’t have to rise too.”

On the other hand, the regular STI screening recommended for people on PrEP encourages prompt diagnosis and treatment, which reduces onward transmission and could potentially contribute to lowering STI rates among PrEP users compared to non-users.

Read the full story.

University of Pittsburgh’s Dr. Ken Ho talks about PrEP

Dr. Ken Ho at Pitt

Dr. Ken Ho at Pitt

The Centers for Disease Control and Prevention are working to inform patients and health care providers of a new, anti-viral pill that they estimate can drastically reduce the risk of infection.  Here to tell us more about this treatment and discuss why it hasn’t been adopted by clinicians in the region are Dr. Ken Ho, an HIV specialist at the University of Pittsburgh and Jason Herring, director of programs and communications at the Pittsburgh AIDS Task Force.

Listen to the broadcast on Essential Pittsburgh 90.5 WESA, Pittsburgh’s NPR station.

Paying for PrEP without breaking the bank

From thevoice.com

paying for PrEPThere’s a lot of misinformation circulating around the internet and in conversations about PrEP (Pre-exposure prophylaxis), the single-daily dose of Truvada, once only used to treat those living with HIV, but now available and approved by the FDA to prevent new HIV infections in negative individuals. PrEP has proved to be more than 90 percent effective in clinical trials when taken as prescribed along with condom use. That’s great. But paying for PrEP, whether you’re insured or not, can be a stressful and expensive experience.Georgia Voice is here to provide you with some basic information about how you can get access to and pay for PrEP. This is by no means a comprehensive list. And of course, you’ll want to consult your health care provider before beginning any drug regimen.

Get more information on thevoice.com.

Research shows structural barriers need to be addressed for PrEP to have an impact

From aidsmap.com

The uptake of PrEP in people who need it risks being limited due to low levels of awareness, gaps in health insurance, opaque bureaucratic procedures, under-usage of medical services, and limited awareness and skills in healthcare providers, according to an analysis published online ahead of print in Clinical Infectious Diseases. Also taking into account sub-optimal adherence among some PrEP users, the researchers conclude that just 15% of gay men in the American city of Atlanta who could benefit are likely to achieve protection from HIV with PrEP.

The PrEP care cascade

Colleen Kelley and colleagues at Emory University outline a ‘care cascade’ or ‘continuum of care’ for PrEP which identifies the key steps in the process of getting hold of PrEP and using it effectively. Analysis of the care cascade can help focus attention on where there are significant barriers to a person moving on to the next step.

Continue reading.

Exactly zero men on PrEP contract HIV in 2.5-year study

 

From hivplusmag.com…

Zero men on PrEP get HIV new study findsAfter two and a half years of trials, a new study has found no new HIV infections among a group of people on pre-exposure prophylaxis (PrEP). For 32 months, researchers at the Kaiser Permanente Medical Center in San Francisco tracked the health of over 600 people as they used Truvada daily to prevent the virus in a real-world setting.

The average age of the study participants was 37, and 99 percent were men who have sex with men. The average length of individual usage was 7.2 months. Members of this group also reported a higher likelihood of having multiple sex partners than those not using PrEP. No one in the study contracted HIV.

Lead author Jonathan Volk, a physician at Kaiser Permanente San Francisco, emphasized that this is the first time such a study has been done in a clinical practice setting at this size. The findings were published Wednesday in Clinical Infectious Diseases, a leading journal of studies on infection disease.

Continue reading.

The medical staff at the Pitt Men’s Study emphasize that PrEP is not a substitute for condoms. It should be used in addition to condoms, to further reduce your risk. It is also important to note that PrEP doesn’t protect against other STDs like syphilis, chlamydia, and gonorrhea. To learn more about PrEP, check out the CDC’s Website. If you have questions about PrEP, you can speak to your doctor. You can also call the PrEP clinic at the University of Pittsburgh Medical Center: (412) 647-0996.

HIV prevention pill a tough sell among Latinos

From NPR.org

“It hasn’t really hit the Latino community yet,” Jesse Hinostroza, an HIV prevention specialist with AltaMed health clinics, says while sitting at a table with a bowl of condoms and a stack of bilingual pamphlets about the pill. “They aren’t educated about it.” In California, New York, Texas and elsewhere, health workers are trying to get more high-risk Latino men to use the drug, Truvada. AltaMed’s efforts are being paid for by Gilead, the pharmaceutical company that makes Truvada.

The medication, which is used for “pre-exposure prophylaxis,” or PrEP, was approved by the FDA in 2012 for HIV prevention and has been shown to be more than 90 percent effective when used correctly. But health workers are encountering barriers among Latinos. Those barriers include a lack of knowledge about the drug, and the stigmas attached to sleeping with men and to perceived promiscuity. Many Latinos also have concerns about costs and side effects.

Read the full article.

New site answers your questions: “What is PrEP?”

From whatisprep.org

PrEP means Pre-Exposure Prophylaxis, and it’s the use of anti-HIV medication that keeps HIV negative people from becoming infected. PrEP is approved by the FDA and has been shown to be safe and effective. A single pill taken once daily, it is highly effective against HIV when taken every day. The medication interferes with HIV’s ability to copy itself in your body after you’ve been exposed. This prevents it from establishing an infection and making you sick.

Even though PrEP has been around in the U.S. for over a year, not a lot of people know about it. And, even fewer people feel like they know enough about it to be able to make an informed decision about whether or not to use it. For those who do use it, the information they have might be more focused on practical issues, like where to get it, rather than on what PrEP does in the body to prevent HIV infection.

By using animation to show PrEP in the body and why “once a day” is recommended, people can see what PrEP does and people who currently use PrEP can create an image of what happens when they take a PrEP pill every day.

View the video below to get information about PrEP and see an illustration of how it can work inside the body to prevent HIV infection.

Learn More About PrEP

See CDC 2014 Clinical Practice Guidelines at http://www.cdc.gov/hiv/pdf/PrEPguidelines2014.pdf

AIDS.gov – PrEP information page (aids.gov/hiv-aids-basics/prevention/reduce-your-risk/pre-exposure-prophylaxis)

AIDSinfoNet – Reliable, Up-To-Date Treatment Information(aidsinfonet.org/fact_sheets/view/160)

AVAC – Global Advocacy for HIV Prevention (avac.org/ht/d/sp/i/262/pid/262)

Avert – AVERTing HIV and AIDS (avert.org/pre-exposure-prophylaxis.htm)

CDC – Questions and Answers from the U.S Centers for Disease Control and Prevention (cdc.gov/hiv/prevention/research/prep)

My PrEP Experience – Real stories from real people who adopted PrEP for prevention in the US (myprepexperience.blogspot.com)

PrEP Facts – San Francisco AIDS Foundation PrEP information in visual format for MSM and heterosexual individuals, with an option for Spanish(prepfacts.org)

PrEP Watch – Interactive webpage with information and resources on gaining access to PrEP (prepwatch.org)

PrEParing for HIV – An Epidemic Interventions Initiative by the University of California

Project Inform – Videos, publications and resources (projectinform.com/prep)

SFHIV – City and County of San Francisco Department of Public Health’s PrEP information page (sfhiv.org/resources/prep)

Guidance for Use of PrEP in Practice and Research Settings

WHO – World Health Organization (who.int/hiv/pub/guidance_prep/en)

CDC – Downloadable PDF from the Centers for Disease Control and Prevention (cdc.gov/nchhstp/newsroom/docs/CDC-Interim-PrEP-Guidance-012811.pdf)

PrEP use rising in United States among men

From aidsmap.com

The number of people using Truvada for pre-exposure prophylaxis (PrEP) in the US is increasing and a growing proportion of users are men, according to an analysis of data from approximately half of American pharmacies presented this week at the HIV Drug Therapy Glasgow conference.

PrEP refers to the use of antiretroviral medications to prevent HIV infection. Gilead Sciences’ Truvada(tenofovir + emtricitabine) taken once daily was shown to be effective in the iPrEx study of mostly gay and bisexual men, reducing the risk of HIV infection by 42% overall, rising to 92% among participants with blood drug levels indicating regular use. A mathematical model suggested that taking Truvadafour times per week would provide 99% protection, and in an open-label extension of iPrEx none of the men who took Truvada at least this often became infected.

The US Food and Drug Administration (FDA) approved once-daily Truvada for PrEP in July 2012. In May of this year, the US Centers for Disease Control and Prevention (CDC) recommended that people at ‘substantial risk’ should consider PrEP to prevent HIV infection, and the World Health Organization (WHO) has also recommended PrEP as an option for at-risk gay men.

Yet uptake of Truvada PrEP has not been as widespread as many had hoped, facing barriers such as lack of awareness among people at risk for HIV, resistance from some medical providers and inconsistent insurance coverage.

Continue reading on aidsmap.com.

Find out why these gay and bi men have decided to go on PrEP

From the Advocate online

Despite recommendation by the Centers for Disease Control and Prevention, and studies that indicate that PrEP can reduce HIV transmission by 96 and up to 99 percent, there are still relatively few gay and bisexual men on the drug.

It can be hard to find anyone among your friends to ask about it. And what makes a person decide they want to go on the once-daily pill varies a lot. The Advocate reached out to gay and bi men, as well as serodiscordant couples, who use the drug to hear their reasons. They offered advice for those on the fence about it. Read their stories in their own words.

WHO recommends PrEP for gay and bi men at risk for HIV

From the Bay Area Reporter online

Gay and bisexual men who are at risk for HIV infection should consider using antiretroviral drugs for pre-exposure prophylaxis, better known as PrEP, according to new guidelines from the World Health Organization.

The WHO recommendation is similar to U.S. Centers for Disease Control and Prevention guidelines released in May, which state that health care providers should consider advising people at “substantial risk” to use PrEP to prevent HIV infection.

“With the WHO’s recommendation, two of the world’s most important public health institutions have recommended that gay and bisexual men who could become infected by HIV carefully consider PrEP,” said Project Inform Executive Director Dana Van Gorder. “In Project Inform’s view, this would especially include men and transgender women who ever bottom without condoms.”

Noting that HIV infection rates among gay and bi men remain high almost everywhere and new prevention options are urgently needed, WHO strongly recommended that men who have sex with men consider taking antiretroviral drugs as an additional method of protection along with condoms.

Continue reading here.

Truvada as pre-exposure prophylaxis (PrEP) against HIV takes about a week to be effective in preventing infection

From aidsmeds.com

Truvada (emtricitabine/tenofovir) as pre-exposure prophylaxis (PrEP) against HIV takes an estimated seven days to reach full efficacy and may protect for nearly a week afterward, the National AIDS Treatment Advocacy Project (NATAP) reports. But those taking PrEP should not assume these are hard facts at this time. Presenting their findings at the 15th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy in Washington, DC, researchers conducted an analysis of 11 men and 10 women who took daily Truvada as PrEP for 30 days and then, after stopping the drug, remained in an additional 30 days of follow-up.

Continue reading on aidsmeds.com.

Just-released guidelines: Pre-Exposure Prophylaxis (PrEP) use for HIV prevention

From AIDS.gov

The U.S. Public Health Service and the Centers for Disease Control and Prevention released guidelines for the use of daily oral antiretroviral pre-exposure prophylaxis, or PrEP, for HIV infection, entitled: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2014 [PDF 867KB].

These guidelines provide health care providers with recommendations on the use of PrEP to prevent HIV, and include a supplement [PDF 690KB] with additional materials and tools for clinicians who prescribe PrEP and their patients. These guidelines replace previous interim guidance released by CDC for the use of PrEP.

CDC recommends PrEP for HIV-uninfected patients at substantial risk for HIV infection, including patients who have any of the following indications:

  • Is in an ongoing relationship with an HIV-infected partner;
  • Is not in a mutually monogamous relationship with a partner who recently tested HIV-negative; and is a
  • gay or bisexual man who has had sex without a condom or been diagnosed with a sexually transmitted infection within the past six months;
  • heterosexual man or woman who does not regularly use condoms when having sex with partners known to be at risk for HIV (e.g., injecting drug users or bisexual male partners of unknown HIV status); or
  • Has, within the past six months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use.

PrEP is a powerful HIV prevention tool. However, for sexually active people, no prevention strategy is 100% effective. Therefore, the guidelines also recommend that physicians encourage patients to use PrEP with other effective strategies—like using condoms, testing for HIV with partners, reducing the number of partners, and having partners who are HIV positive take antiretroviral therapy—to provide even greater protection from HIV.

To achieve the full promise of PrEP, each of us has a critical role to play. Clinicians play a central role in increasing awareness and the delivery of this new prevention method when there are indications for its use. Advocates can help raise PrEP awareness and understanding about PrEP, especially in at-risk populations. Medical associations and professional organizations can help educate providers and share clinicians’ experiences delivering PrEP, and HIV prevention programs can integrate PrEP education into existing activities.

We mark a milestone with the release of these new guidelines—a promising tool for HIV prevention, and one that has the potential to alter the course of the U.S. HIV epidemic.

For more about PrEP and its use. Please visit the CDC PrEP page.