Does PrEP use lead to higher STI rates among gay and bi men?

From POZ.com

Rates of new sexually transmitted infections (STIs) are much higher among men who have sex with men (MSM) taking Truvada (tenofovir disoproxil fumarate/emtricitabine) as pre-exposure prophylaxis (PrEP) than among other MSM. More research is needed, however, to determine whether starting PrEP leads to higher STI rates among MSM.

Publishing their findings in the journal AIDS, researchers conducted a meta-analysis of 18 studies of MSM in which new STI diagnoses were reported. Five of the studies included MSM given PrEP, and 14 were conducted with MSM who were not given PrEP. (One study, the PROUD study, included both a group given PrEP immediately and a group given PrEP on a deferred basis and thus fell into both the PrEP and the non-PrEP categories of studies.)

The researchers found that the rates of new diagnoses of STIs among MSM given PrEP were 25.3 times greater for gonorrhea, 11.2 times greater for chlamydia and 44.6 times greater for syphilis, compared with the rates among MSM not given PrEP. After repeating the analysis but excluding studies conducted before 1999, the researchers found that the results were similar.

Looking to parse apart the contributing factors to the higher rate of STI diagnoses among MSM given PrEP, the meta-analysis’s authors theorized that the regular STI testing that is part of taking PrEP might have led to a higher rate of STI detection. A greater number of sex partners and a higher rate of condomless sex among those given PrEP might also have contributed to their higher STI diagnosis rate.

The study is limited by the fact that, except in the case of PROUD, the researchers compared different populations of MSM from study to study. They also compared groups that tested for STIs at different frequencies and used different variations of STI tests. Additionally, the PrEP studies specifically sought out participants engaging in high-risk sexual behaviors, while the other studies might have had different criteria with regard to sexual risk taking. However, participants in many of the non-PrEP studies were indeed recruited based on some level of reported sexual risk taking.

 

Read the full article.

 

Anti-HIV pill safe among gay, bisexual adolescent boys

From Reuters Health

A pill that protects against the human immunodeficiency virus (HIV) can be safely used by young men who have sex with men, according to a new study.

In a diverse group of teen boys at high risk for HIV infection, pre-exposure prophylaxis (PrEP) in the form of a pill that combines the drugs emtricitabine and tenofovir disoproxil fumarate was well tolerated, researchers found.

“I do hope clinicians increase their comfort with being able to provide PrEP to adolescents,” said lead author Sybil Hosek, a clinical psychologist and HIV researcher at Cook County Health and Hospitals System’s Stroger Hospital in Chicago.

She hopes the new data will be submitted to the U.S. Food and Drug Administration (FDA) and will encourage the agency to approve the pill for use by younger people. The pill is currently approved for HIV prevention in adults.

The drug was first approved by the FDA in 2012 as Truvada, which was marketed by Gilead. Trials found that the drug reduced the risk of HIV infection by over 90 percent.

But little evidence was collected on its use among gay and bisexual adolescent males, who are among those most at risk for HIV infection.

For the study, researchers enrolled 78 gay and bisexual young men, ages 15 to 17, from six U.S. cities. The participants all tested negative for HIV at the start of the study, but were at high risk for an infection.

Participants received a counseling session about HIV risk, plus access to daily doses of PrEP for the next 48 weeks.

Overall, 47 participants completed the study.

Only three adverse events occurred that were possibly related to PrEP, the researchers found.

“I think the safety piece is important,” Hosek told Reuters Health. “It was well tolerated. We didn’t see many complaints about side effects. We did not see many adverse events.”

The researchers also didn’t find an increase in sexually risky behaviors over the study period.

Three young men did become infected with HIV, however. Blood samples suggest they were taking less than two doses of PrEP each week at the time of infection.

The rate of HIV infection in the study was 6.4 cases per 100 people per year, which is about twice as high as the rate seen among men ages 18 to 22 years enrolled in a similar trial, the researchers write in JAMA Pediatrics.

“I shudder to think what the (HIV infection) rate would be if we didn’t offer PrEP,” said Hosek.

She said the high rate of HIV infections is likely due to poor adherence. While more than 95 percent of the young men had evidence of the preventive medication in their blood during the first 12 weeks of the study, by week 48 only about 15 percent of participants had detectible levels of the drug.

Low adherence to medications is a common problem with adolescents, said Hosek.

Dr. Renata Arrington-Sanders writes in an editorial accompanying the new study that making PrEP a success among gay and bisexual adolescents will require effort.

“This work suggests that adolescents may require additional visits than what is currently recommended by national guidelines and suggests a need for multiple team members to address structural barriers to accessing PrEP, assist with youths’ interpretation of HIV risk, and support self-efficacy to swallow and adhere to medications,” writes Arrington-Sanders, of Johns Hopkins University in Baltimore.

Hosek agreed, calling for doctors to be more connected to their young patients on PrEP.

“Clinicians should not be afraid to see adolescents more frequently, maintain a connection with the adolescents and keep them engaged,” she said.

SOURCE: bit.ly/2wDAUi5 and bit.ly/2wCTF5i JAMA Pediatrics, online September 5, 2017.

Can new ‘Smart PrEP Pills’ increase adherence for HIV-prevention medication among young people?

From the Daily Herald online…

How does the smart PrEP work?

“The pill Truvada — the only PrEP drug approved by the Food and Drug Administration — has a sensor tablet encapsulated over it, so that when the pill is swallowed, the sensor tablet comes in contact with gastric fluid in the stomach and creates an electrical signal,” explained Dr. Gregory Huhn, CCHHS’ Associate Professor of Infectious Diseases and principal investigator of the trial. “The electrical signal is less than the frequency of a heartbeat, so nobody is going to feel it. But it transmits a signal in real-time that the pill has been ingested.”

By having a record of when the pill has been taken that goes to both the patient and his or her doctors or providers, the providers can reach out to patients who haven’t been taking the pills as directed and find out if there are any issues they can help resolve-like medication side effects a patient might be having or that they’ve run out of medication, Brothers said.

PrEP is supposed to be taken once a day.

Read the full article.

HIV pre-exposure prophylaxis can be taken as needed

From Reuters Health

Men at risk for HIV infection can safely take pre-exposure prophylaxis (PrEP) when they need it, instead of every day, suggests a new study.

In a study of gay and bisexual men, researchers found that taking four doses of PrEP around the time of sexual activity cut the risk of being diagnosed with HIV by 97 percent.

The pill, marketed by Gilead as Truvada, contains a combination of the two anti-HIV drugs emtricitabine and tenofovir disoproxil fumarate. Truvada was approved by the U.S. Food and Drug Administration for PrEP in 2012. Typically, the pill is taken daily.

The participants and the dosing schedule used in the new study were drawn from the IPERGAY clinical trial, which was discontinued early in 2014 after the drug was found to be highly effective at protecting against HIV.

“There are consistent data suggesting that on-demand PrEP before and after sex strictly following the IPERGAY dosing schedule . . . is also highly effective and could be an alternative to daily PrEP,” said Dr. Jean-Michel Molina, lead author of the new study and principal investigator of the trial.

The 361 men in the new study were enrolled from France and Canada after the completion of the IPERGAY trial. They were told to take two doses of Truvada between two and 24 hours before sex, another dose 24 hours later and a fourth dose 24 hours after that.

One participant who stopped taking PrEP during the roughly 18 months of follow-up was diagnosed with HIV, researchers reported July 23 in The Lancet HIV to coincide with presentation at the 2017 International AIDS Society Conference in Paris.

The overall rate of HIV among those in the study was 0.19 cases per 100 people per year. That compared to 6.60 cases per 100 people per year among men who were assigned to take a dummy pill during the larger trial.

The researchers found that about 14 percent of study participants reported minor stomach issues that eventually cleared up. Only four men stopped using the medication.

Read the full article.

Undetectable viral load “completely effective” at stopping HIV transmission, study finds

From Buzzfeed

A groundbreaking new study found zero transmissions occurred between HIV-positive men with an “undetectable viral load” due to treatment, and their HIV-negative partners, across thousands of instances of anal sex without a condom.

The Opposites Attract study, led by professor Andrew Grulich from the Kirby Institute, followed a cohort of 358 gay male couples – one partner HIV-positive, the other HIV-negative – in Australia, Thailand and Brazil.

The HIV-positive partners in the study had an “undetectable viral load”, meaning they are on treatment to suppress the virus so it is undetectable in the blood.

Not a single HIV transmission occurred across the almost 17,000 times participants reported having anal sex without a condom.

12,000 of those sexual encounters were protected solely by the HIV-positive partner’s undetectable viral load, and in the other 5,000, the HIV-negative partner was also taking a drug to protect against contracting HIV, known as PrEP.

“It really does confirm that undetectable viral load is completely effective at preventing transmissions in gay couples,” Grulich told BuzzFeed News from Paris, where he is presenting the research to the International Aids Society (IAS) Conference on HIV Science.

“Essentially, we’re documenting that this is a form of safe sex for couples in this situation.”

Read the full article.

Video series tackles bareback reality of HIV prevention

From South Florida Gay News

One film student is showing a “fun, sexy and outrageously frank 21st-century sex-ed for gay adults.”

“PrEP is an HIV prevention strategy that deals with sex, namely bareback sex,” film student Chris Tipton-King told Queerty. “And I got tired of people tip-toeing around that fact.”

PrEP stands for pre-exposure prophylaxis and reduces the risk of getting HIV from sex by more than 90 percent. Truvada is the drug prescribed for the treatment.

Tipton-King wasn’t happy with depictions of PrEP, which he felt was too sanitized and “awkward.” So as one of his assignments for his master’s degree in cinema, he created “The PrEP Project.” It’s a four-part video series that shows a more realistic side to gay men, their sex lives and the use of PrEP. Each video is 5-minutes long.

Read the full article and watch the videos on South Florida Gay News.

The new gay sexual revolution

From Advocate.com

Now there’s hope the younger generation may also experience worry-free sex lives — without the side effects of living with HIV. The use of the antiretroviral drug Truvada as pre-exposure prophylaxis, or PrEP (it’s the only medication approved for HIV prevention), has been shown to reduce the chance of HIV transmission to near zero. Since the medication was first approved as PrEP in 2012, only two verified cases of transmission have been documented among those who adhere to the daily schedule (a third, according to HIV expert Howard Grossman, could not be confirmed). New, longer-lasting PrEP injectables should reach market in the next few years. Studies suggest that on-demand PrEP (such as taking it before and after sexual activity) may also be effective.

“This is a revolution!” Gary Cohan, MD, who prescribes PrEP, told us in 2016. “This should be above the fold in The New York Times and on the cover of Time magazine. A pill to prevent HIV?”

Read the full article on Advocate.com.