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New PrEP Studies Offer Good News But Watch That Burning Down Below (Special Report)

When it comes to recent rates of HIV and STIs, we have some good news and some bad news

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December 28, 2015 :: 2:17 PM

For a few hours earlier this month, LGBT and HIV/AIDS advocates felt slightly giddy, as if after an interminable period of turbulent seas and storm clouds, a lighthouse beacon cut through the darkness and promised an end to the seemingly never-ending HIV/AIDS crisis.

“This year, 883 HIV tests were administered, and there were zero positive results” from a “blitz” of HIV testing during Pride Week last June, wrote West Hollywood Social Services Manager David M. Giugni in a memo to the mayor and City Councilmembers. “This is the first year that there has been a 0% positivity rate for HIV.” Unfortunately, Giugni added, “the positivity rate for syphilis, gonorrhea and chlamydia are up from the previous year.”

Openly HIV-positive West Hollywood City Councilmember John Duran shouted the “unbelievable” news. “We are going to win this war against AIDS! This is the beginning of the end of the epidemic!” Duran exclaimed to Frontiers.

But then the clarifications began. Jim Key, Chief Marketing Officer for the Los Angeles LGBT Center, which participated in the Pride Week testing blitz, warned that people should not read too much into the data. “The percentage of people who tested positive for HIV at The SPOT, the Center’s former STD testing location in West Hollywood, was 1%, and it has remained at that level since the Center opened its new testing center, Center-WeHo, on Oct. 20,” Key said in an email.

While the news out of West Hollywood was “encouraging,” the Center’s Director of Health Christopher Brown told KNBC, “In some communities, like with gay and bisexual men, and particularly younger gay and bisexual men of color, we’re not seeing the decreases.”

The city corrected the error. “The corrected data indicates that there were, in fact, 10 HIV-positive results in 883 tests. This represents a positivity rate of 1.1 percent,” bringing it more in line with The Center’s findings. “While the number is not zero, this positivity rate is the lowest rate measured since the annual Pride testing blitz began in 2005. It demonstrates important and encouraging progress in the fight against HIV.”

San Francisco, however, did report zero new HIV infections. San Francisco AIDS Foundation’s Magnet director Steve Gibson told the 2015 Centers for Disease Control and Prevention HIV Prevention Conference in Atlanta  that there were no new HIV infections in their nurse-led community-based HIV prevention PrEP (preexposure prophylaxis) program.

The Magnet study reported:

A total of 695 people have been screened for PrEP interest and eligibility with 90% enrolling in the program. The mean age of enrolled participants is 34 years with an age range of 18 to 71. Participants reported an average of 18.5 sexual partners per year with the most common reason for initiating PrEP being condomless sex (91%) followed by having an HIV-positive partner (12%)…..

The majority of people enrolled in the PrEP health program reported the same or more condom-protected sex at each time point (72% at month 1; 70% at month 4; 63% at month 7).

“We found that most men do not increase the amount of condomless sex while on PrEP,” said Pierre-Cédric Crouch, PhD, ANP-BC, the nursing director at Magnet. “About 91% of our clients were already having condomless sex when they started PrEP, so condomless sex was already high among our participants to begin with. But this is less than a year’s worth of data. With more time we will be better able to understand how PrEP impacts a person’s life.”

While that was just one community study, another study conducted by researchers at California’s Kaiser Permanente in California found that none of the 657 noninfected people on PrEP they followed for an average of seven months contracted HIV.

“That’s really compelling data on how effective this medication is,” Jonathan Volk, physician and epidemiologist with Kaiser Permanente San Francisco Medical Center and lead author of the study published last Sept. in the journal Clinical Infectious Diseases, told the Wall Street Journal.

“Our study is the first to extend the understanding of the use of PrEP in a real-world setting and suggests that the treatment may prevent new HIV infections even in a high-risk setting,” Volk said in a Kaiser Permanente press release. “Until now, evidence supporting the efficacy of PrEP to prevent HIV infection had come from clinical trials and a demonstration project.”

Among the details of the study, the press release reported:

The average age of PrEP users was 37, and 99 percent were men who have sex with men. Compared with people who did not use the PrEP protocol, users were more likely to report multiple sex partners, and were not more likely to report having an HIV-infected sexual partner.

Of 143 patients who were asked about behavior change after six months of PrEP use, the number of sexual partners was unchanged in 74 percent, decreased in 15 percent, and increased in 11 percent. Condom use was unchanged in 56 percent, decreased in 41 percent, and increased in 3 percent.

At six months after initiation, 30 percent of PrEP users had been diagnosed with at least one sexually transmitted infection, or STI. At 12 months, 50 percent of PrEP users had been diagnosed with any STI; 33 percent had a rectal STI, 33 percent had chlamydia, 28 percent had gonorrhea, and 5.5 percent had syphilis.

“Without a control group, we don’t know if these STI rates were higher than what we would have seen without PrEP,” said co-author Julia Marcus, PhD, MPH, postdoctoral fellow at the Kaiser Permanente Division of Research. “Ongoing screening and treatments for STIs, including hepatitis C, are an essential component of a PrEP treatment program.”

According to senior author Bradley Hare, MD, director of HIV Care and Prevention at Kaiser Permanente San Francisco, people on a PrEP regimen should be tested frequently for STIs and monitored closely for HIV infection, as well as for side effects of Truvada, including changes in kidney function.

The Wall Street Journal also pointed out that “fewer than 22,000 people are estimated to have taken PrEP for prevention, according to an analysis this year in the journal Current Opinion in HIV and AIDS.”  That’s in the context of the highly published CDC report last Nov.  that 1.2 million adults in the U.S.—including one in four gay and bisexual men—are at substantial risk for contracting HIV and could prevent infection by through sexual transmission by as much as 92% taking the daily pill Truvada and following the PrEP regime. Still, one in three primary care doctors haven’t heard of the medication.

The January 2016 journal Current Opinion in HIV & AIDS features a very good report entitled “What people want from sex and preexposure prophylaxis” with a good behavioral analysis of not only HIV positive and HIV negative people on PrEP but what messaging works and how doctors and HIV researchers shy away from talking about sex itself:

Kane Race, cultural studies scholar, observed that PrEP has created opportunities to consider pleasures of sexual practices more fully…

‘…one of the tacit commitments of HIV prevention science is to manage the affective intensities and complications of sex. These days it is possible to sit through entire conferences apparently devoted to HIV prevention in which the issue of sexual practice is barely mentioned…. One of the new prevention strategies that, despite its biomedical lineage, has thus far been unable to shake its contaminating associations with the apparent excesses of sexual pleasure is PrEP’ [23▪▪].

Race pushes us to recognize that HIV prevention research has become arguably divorced from sex, or worse, is antagonistic toward sex. The antagonism associated with sex and HIV prevention may be considered a form of stigma in which sexual practices that are so full of meaning for people are reduced to HIV risk, a negatively valued characteristic. Stigma of this nature is too often reinforced by medical providers who serve as gatekeepers to biomedical interventions and may subtly convey stigmatizing messages about sexual behavior rather than adopting a sexual wellness approach.”

The report concludes with optimism:

Much will be learned from PrEP use. Further study to understand to the extent to which concepts such as agency, preservation of relationships, and pleasure resonate for young persons (particularly women) in high prevalence settings is an important next step in PrEP research. Although the intended purpose of PrEP was to lower the incidence of HIV infection, PrEP users report being attracted to benefits that are salient, affective, and occur in the present. Such PrEP benefits include more pleasure, more intimacy, stronger relationships, feeling safer, less stigma, feeling empowered by planning for sexual and partnership goals, and ability to plan families. Creating a compelling narrative around sexual and social goals was an important lesson learned from successes in perinatal transmission prevention [69▪▪]. Focus on these benefits will provide insights and a compelling narrative that may bolster our struggle to end HIV transmission.

The relatively good HIV prevention news was discussed during the news from the CDC Conference Dec. 6-9 in Atlanta. But though HIV diagnoses declined by almost 20% between 2005-2014, “gay and bisexual men are not seeing equal levels of success.”

The statistics varied by race and ethnicity, with diagnoses among white gay and bisexual men decreasing 18%, while diagnoses among Latino gay and bisexual men were up 24%; black gay and bisexual men increased by 22%, with leveling off starting in 2010. Young black gay and bisexual men, ages 13-24, experienced a steep 87% increase, but that trend has leveled off with a 2% decline.

And while the CDC said last month that sexually transmitted infections are increasing “at an alarming rate,” and both the West Hollywood and San Francisco reports indicate either consistent presence or a rise in STDs, there appears to be much less concern among most HIV prevention advocates about contracting the other significant sexually transmitted diseases.

The CDC reports that in 2014, rates of primary and secondary syphilis increased 15.1% in one year among men who have sex with men—who account for 83% of reported cases among men when the sex of the partner is known, the CDC says. Additionally, 51% diagnosed with syphilis in 2014 were also HIV-positive.

On his Facebook page, HIV specialist Dr. Gary Cohen expressed “alarm” at the rise in STDs but cautions against “PrEP-blaming” as a “singular cause” for the increase in sexually transmitted infections.

“It’s my opinion that increasing STIs and decreasing condom use is a result of a complex combination of factors, including a markedly lowered perception of ‘risk’—a generational shift in which sex and death have become unlinked,” says Cohen in an email.

Adding to that complexity, Cohen says, is “the proliferation of hookup apps making more frequent sexual encounters easier, some contribution from the reassurance that PrEP confers (although how much is impossible to know), the misconception that STIs are all ‘benign annoyances’ and completely or easily treatable.”

Cohen also notes that, “ironically,” another contributing factor is the strong pushback from a few vocal PrEP educators/advocates that unfettered sexual activity/’freedom’ without consequence is the ‘new normal’ and is a ‘right’ for a community constrained by latex for so many years.”

In his first Facebook posting after the CDC report on STDs, Cohen underscored the CDC’s alarm:

“This alarming new CDC report of an enormous and unprecedented increase in STD’s like gonorrhea, Chlamydia, HPV & syphilis – and most frighteningly hepatitis C – in MSM is very real and truly a call to action for all of us.

This unfortunate development – very likely a result of decreasing condom use – MUST not be ignored, defended or rationalized just because PrEP has been such an unqualified success in preventing HIV. Truvada is NOT a virtual condom nor is it a reason to return to the “good old days” of the 1970’s when STD’s were just a minor annoyance.

As you are well aware, I’m a staunch PrEP advocate and by no means a “sex shaming” physician, but even an experienced doc like me has a duty to warn you when I’m alarmed by the rise in STD’s in my patients in the past 36 months. This is not OK.

We’re down to only one effective medication to treat gonorrhea (injectable ceftriaxone) and treating hepatitis C is an expensive ($100,000) endeavor.

I’m urging everyone who advocates or teaches about PrEP to include this information in your HIV prevention and safer sex messages in a responsible effort to protect all those who we love. It won’t dilute the power of PrEP; it will hopefully help prevent the next STD disaster.” (Emphasis mine)

In fact, AIDS activists like the late Michael Callen argued that HIV came out of the cesspool swamp of STDs in the late 1970s. On Facebook, Cohen makes an emotional plea to learn from history—when gay men experienced “the awful atmosphere of fear and dread and omnipresent disease/death” during the AIDS epidemic.

“During those dark days, the math was rather straightforward: No Condom = Possible Death. That equation is now moot. With the distinct exception of all of these STDs,” Cohen writes. “So here’s my point. Let’s have sex. Enjoy sex again. Promote health. Use PrEP. Use TasP. Endeavor to eliminate HIV from the equation. Keep STDs as rare as possible by being regularly tested, treated when necessary and resisting the temptation to have sex with as many partners as Grindr/Scruff, etc., endlessly serves up. Be smart. Be selective. Be careful.”

And, he adds, “Understand all of the good and bad things that can happen when condoms are removed from the sexual equation. And take personal responsibility for your health and the health of others. We’re in this together. Godspeed to us all.”

This is an updated and expanded version of a story in the current edition of Frontiers Magazine.

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