Researchers Investigate Acceptability for PrEP in Chinese MSM

via PLoS ONE, by Feng Zhou

Introduction

In pre-exposure prophylaxis (PrEP), antiretroviral (ARV) drugs are given to HIV-negative people to decrease their chance of becoming infected. Several studies conducted among men who have sex with men (MSM) have shown that PrEP awareness was very low, and few participants reported having the experience of PrEP use, even in some countries where it is available. Although strategies including abstinence, being faithful, and condom use (ABC) have been proved to be effective for prevention of HIV transmission, the virus still prevails among MSM. It was estimated that 2.6 million individuals were newly infected in 2009 worldwide, which 19% fewer than the 3.1 million in 1999. China had about 740,000 people living with HIV and 105,000 with AIDS by the end of 2009. Homosexual intercourse has become a major mode of HIV transmission since 2009, and the prevalence of HIV in MSM has increased significantly from 2.5% in 2006 to 8.6% in 2009. A sociological study has estimated that there are 1.8–2.4 million homosexual or bisexual men in mainland China. In China, high-risk behavior, such as multiple partners and unprotected sex, have been reported to be common in this group. Also, recent studies have reported rapid transmission of HIV in this specific population from various geographic areas in China, despite the efforts made by the national and local governments and non-governmental organizations in the past few years. New effective approaches are urgently needed for this population.

In recent decades, researchers have made great efforts to explore alternative biomedical interventions, such as male circumcision (MC), HIV PrEP and post-exposure prophylaxis (PEP), HIV vaccines, and microbicides. Among these potential strategies, PrEP is considered to be one of the most promising strategies in MSM. Several animal and human studies have suggested that ARV drugs might reduce the risk of HIV infection either by PrEP or by non-occupational PEP. A 12-month PrEP clinical trial of daily oral tenofovir disoproxil fumarate (TDF) for HIV prevention was performed among 400 HIV-negative Ghanaian women, and achieved good acceptability and >82% adherence. In November 2010, the US National Institutes of Health (NIH) announced the results of the iPrEx trial of PrEP conducted among 2499 HIV-seronegative MSM in six countries, which showed that daily oral Truvada, a combination of emtricitabine (FTC) and TDF, reduced risk of HIV incidence by 44%, with a median 1.2 years follow-up, compared with the placebo group, and >75% adherence was reached. These findings represent a major advance in HIV prevention research, providing the first evidence that PrEP, when combined with other prevention strategies, can reduce HIV risk among MSM. A further study is ongoing in HIV Prevention Trials Network (HPTN) 067 to evaluate the feasibility of intermittent dosing of PrEP. Recent results from Partners PrEP and CDC TDF2 have shown that PrEP with daily oral TDF/FTC or TDF was effective at reducing HIV risk in heterosexual men and women. However, the Fem-Prep program on Truvada, a closed clinical trial implemented by Family Health International (FHI) in partnership with research centers in Africa, does not support the theory of PrEP having an effect on HIV prevention. Therefore, some factors that might influence the efficacy of PrEP, including adherence, sexual behavior, or other factors still need to be determined.

The awareness and acceptability of new strategies are very important when they are recommended for use. Therefore, the objective of our study was to investigate the awareness and acceptability of PrEP among MSM and potential impact factors, which will provide suggestions and guidelines for future clinical trials in China.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Ongoing risk behaviour likely cause of high HIV incidence rate among gay men treated with PEP

via Aidsmap, by Michael Carter

HIV incidence is high among gay men who use post-exposure prophylaxis (PEP), investigators from Amsterdam report in the online edition of AIDS.

Overall, users of PEP were almost four times more likely to become infected with HIV than gay men who did not use the therapy.

There was no evidence that PEP failure was the cause. The investigators believe this is because PEP users continued to put themselves risk of HIV after completing their treatment.

“Our study showed a high incidence of HIV among MSM [men who have sex with men] who used PEP, an indication of ongoing risk behaviour,” write the investigators. “This implies that PEP alone for this group is not sufficient to prevent HIV infection, and a combination of other more comprehensive preventative strategies is needed.”

HIV post-exposure prophylaxis is a four-week course of combination antiretroviral therapy, prescribed after an encounter with body fluids possibly infected with HIV.

It is estimated that the treatment can reduce the risk of infection by up to 81%.

Gay men are the group most likely to request PEP after a possible sexual exposure to HIV. Australian research has shown that gay men who used PEP continued to be at risk of HIV after completing their treatment.

Therefore, Dutch investigators compared HIV incidence among gay men prescribed PEP in Amsterdam between 2000 and 2009, and compared this to the rate of new infections seen over the same period among gay men enrolled in the Amsterdam Cohort Study.

A total of 355 men who received 395 PEP prescriptions were included in study. The majority of individuals took one course of PEP, but approximately 10% of men were provided with multiple prescriptions (two to four).

Adherence rates were high, with 94% of men completing their therapy. HIV status was monitored three and six months after baseline.

Eleven PEP users seroconverted. Two men tested HIV-positive at their three-month follow-up appointment; one individual who did not attend for his three month appointment was diagnosed at month six; and the remaining eight men were HIV-negative at month three, but were HIV-positive at month six.

This provided an HIV incidence of 6.4 per 100 person years among the individuals treatment with PEP.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

'Less education' associated with PrEP and PEP use: only one in five gay men yet aware of PrEP

via aidsmap, by Gus Cairns

A survey (Mansergh) of 454 HIV-negative gay men in four US cities (New York, Los Angeles, Chicago and San Francisco) has found that men with lower educational attainment (high school only) were more likely to use antiretrovirals informally for HIV prevention, either as pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), than men who had had further education.

In a parallel survey of 557 HIV-positive gay men, men with lower educational attainment were, similarly, more likely to share their antiretroviral pills with HIV-negative partners to use as PrEP or PEP.

Taken together, 22% of the men in the two surveys were under 30, 35% in their 30s and 43% 40 or over. A third were black, 38% white and the rest Hispanic or of other ethnicity.

Roughly a third each of the sample had education only to high school level, to some college qualification, or to a university degree.

The survey asked both groups if they had used PrEP or PEP or, in the case of the HIV-positive men, provided it to others, in the last six months.

Informal use of PrEP or PEP was still comparatively uncommon; only a few per cent of those surveyed overall had used ARVs as prevention or provided them in the previous six mnoths.

However men with high-school-only education were two to six times more likely to report using one of these strategies.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Intensive and targeted PEP counselling leads to less risky sex afterwards, fewer HIV infections

Via AIDSMap, by Roger Pebody.

Researchers in San Francisco wished to measure the impact of providing risk reduction counselling to people taking post-exposure prophylaxis (PEP) to prevent HIV infection. They measured changes in sexual behaviour one year later.

They randomised 457 people receiving PEP to either receive two sessions of standard counselling, or an enhanced programme of five counselling sessions.

The standard counselling intervention consisted of two sessions of 20 to 30 minutes each, individually tailored on the basis of social cognitive theory, motivational interviewing, and coping effectiveness training. In the first session, the counsellor and participant explored the details and context of the risk exposure and developed a written risk reduction plan. At the second session a week later, the baseline HIV test result was given. The participant was asked about risk behaviour in the past week and the effectiveness of the risk reduction plan, which was adjusted if necessary.

People receiving the enhanced intervention received the same two sessions, as well as three further sessions, during which difficulties in implementing the plan were explored, contextual factors (such as particular places or emotions) that led to high or low risk behaviour were identified and an increasingly personal risk reduction plan was developed. (A detailed protocol for the five sessions is freely available on the journal’s website).

Adherence counselling was also separately provided on three occasions.

Almost all participants were men, and PEP had commonly been prescribed after unprotected anal sex (80.1%), unprotected vaginal sex (7.5%) or oral sex to ejaculation (5.9%) in the previous 72 hours. Four out of ten people receiving PEP knew that their partner was HIV-positive.

To assess the impact of the two styles of counselling, the behaviour of participants was assessed at the time of taking PEP and one year later.

When the data for all participants were analysed together, the extra intervention appeared to provide a modest benefit, but perhaps one that could not justify the cost of its provision.

The study’s primary outcome was change in the number of unprotected anal or vaginal sex acts. In the six months before taking PEP, participants had had unprotected sex an average of 5.5 times. In people who received two counselling sessions, this dropped by a mean of 1.8, while those getting the extra sessions had 2.3 fewer unprotected sex acts.

The results are more interesting if we only look at those individuals who were taking more sexual risks to begin with. A fifth of the participants had had unprotected sex four or more times in the six months before taking PEP, and the extra counselling had much more impact in this group.

In terms of the primary outcome, those with higher risk receiving the standard two sessions had a reduction in 7.0 unprotected sexual acts, whereas in those getting the extra sessions the average reduction was 13.2 acts.

Whereas 31.5% of higher-risk individuals receiving the standard intervention felt the need to come back for a second course of PEP within a year, this was case in 17.1% of those receiving five sessions.

And most importantly, fewer people were HIV-positive one year later. Among those with higher risk who received two sessions, 12.3% seroconverted. In those who received five sessions, 2.4% did so. (These infections are likely to be due to risk behaviour in the months after taking PEP, not the failure of PEP to prevent infection).

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

The Danish PEP Registry Experience with PEP

The Danish PEP Registry: Experience with the Use of Postexposure Prophylaxis (PEP) Following Sexual Exposure to HIV from 1998 to 2006
Sexually Transmitted Diseases Vol. 37; No. 1: P. 49-52  
Source

Research indicates that postexposure prophylaxis (PEP) with antiretroviral drugs after sexual exposure reduces considerably the risk of HIV infection. Since 1998, Denmark has made PEP available within 24 hours of sexual exposure; however, it can be prescribed only at clinical centers by HIV treatment specialists. The current study sought to describe the use of PEP after sexual exposure from 1998 to 2006.

Using a structured questionnaire, the Danish PEP registry collects data on all cases of PEP use in Denmark. During the study period, there were 374 cases in which PEP was used after sexual exposure to HIV. These cases increased from five in 1997 to 87 in 2006. In 40 percent of cases, the patients were heterosexuals; in 57 percent, the patients were men who have sex with men. In 41 percent of cases, the HIV status of the source individual was unknown; in 90 percent of these cases, the source was a member of a high-risk group. Receptive anal intercourse was involved in 63 percent of cases. The median time to treatment initiation was 11.0 hours (range: 0.5-60.0), and in 95 percent of cases PEP was administered within 24 hours (N=225). Sixty-five percent of patients completed the treatment course.

"This nationwide study showed a steady but moderate increase in the use of PEP after sexual HIV exposure from 1998 to 2006," the authors concluded. "Time to initiation of PEP was low and the PEP prescription practice was targeted toward high-risk exposures."

HIV prophylaxis programs "not working" - Australian study

via 6minutes.com.au, by Michael Woodhead

Programs that offer gay men access to anti-HIV drugs for postexposure prophylaxis after high risk sexual behaviour are not working, an Australian study has found.

While homosexual men tended to use prophylaxis appropriately, they do not modify their high risk behaviour in the longer term and do not use prophylaxis for all episodes of unprotected intercourse, a prospective five year study in Sydney has shown.

Published in the journal AIDS (online 4 May), the findings from the National Centre in HIV Epidemiology and Clinical Research show that almost all the 1427 participants had heard of non-occupational post-exposure prophylaxis (NPEP). Usage of prophylaxis increased over the duration of the study, and was mostly used after unprotected intercourse. In 80% of participants it was used only once.

However, the use of prophylaxis did not result in any change in risk behaviour, a finding the researchers said was ‘disappointing’ given that behavioural counseling was always provided when prophylaxis was dispensed.

The study also found that over the five year study period prophylaxis was only used by men on 7% of high risk periods such as unprotected intercourse, and that users had three-fold higher rate of seroconversion to HIV.

“This study paints a picture of increasing and mainly appropriate use of [prophylaxis] among homosexual men in Sydney,” the authors write.

But given the lack of impact of prophylaxis on either HIV risk behaviour or HIV incidence, there is a need to redesign the programs and improve the interventions to reduce personal HIV risk, they say.

Prevention for HIV serodiscordant couples: it's more than just condoms

via Aidsmap, by Michael Carter

Promoting 100% condom use may not be the most appropriate HIV prevention strategy for serodiscordant couples, according to research presented to the Fifteenth Conference of the British HIV Association. However, researchers found that there was little awareness or use of other methods of HIV prevention, such as post-exposure prophylaxis (PEP) or the impact of viral load on infectiousness.

Investigators recruited 38 serodiscordant couples (where one partner is HIV-positive, the other HIV-negative) to a prospective study lasting three years. Most (30) of the couples were gay men. To be included in the study the couples had to have been in their relationship for at least two years and to have engaged in at least 20 separate episodes of unprotected anal or vaginal sex in the previous twelve months.

The couples were interviewed about their understanding of issues such as PEP, viral load and infectiousness, and the reasons why they engaged in unprotected sex. The investigators hypothesised that there were likely to be three factors underlying unprotected sex in relationships: failure to understand the mechanisms of HIV transmission; emotional reasons; and a low concern about the consequences of HIV transmission.

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Gay men often not accessing PEP despite risk of HIV exposure

“I had just separated recently, so it [unprotected anal sex] was kind of a way of me trying to react, I don’t know, trying to just forget about it, just have fun, you know do drugs and get drunk.”

via Aidsmap

Gay men may not be accessing HIV post-exposure prophylaxis in situations when its use would be warranted, a study published in the online edition of Sexually Transmitted Infections suggests.

Investigators in Brighton conducted interviews with 15 gay men who were currently taking, or had recently completed, a course of post-exposure prophylaxis after unprotected anal intercourse. They found that prior to accessing this treatment, the men generally had a poor understanding of what post-exposure prophylaxis involved.

The investigators also found that although the men described the sexual encounter leading to the accessing of post-exposure prophylaxis as unusual, they could almost all describe other circumstances where their risk behaviour was such that treatment with post-exposure prophylaxis would have been warranted. Furthermore, the interviews suggested that the men attempted to distance themselves from their risk behaviour, attributing it to the use of drugs and alcohol or in some way blaming their sexual partner.

Post-exposure prophylaxis (a short course of treatment with antiretroviral drugs after possible exposure to HIV) is becoming increasing available for individuals reporting sexual risk behaviour. The number of gay men presenting for such treatment has increased following targeted advertising campaigns and the publication of professional guidelines.

There is robust evidence that post-exposure prophylaxis can prevent infection with HIV. But there have been reports of HIV infection despite its use following possible sexual exposure to the virus. In many instances these infections can be attributed to ongoing sexual risk behaviour.

Investigators wished to gain a better understanding of the factors and rationale leading gay men to access post exposure prophylaxis. They were hopeful that the results of their study could lead to the development of health promotion campaigns targeting men who are not accessing this treatment after possible exposure to HIV.

Read the whole Aidsmap article.