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PrEP safe and effective for young men who have sex with men

But waning adolescent adherence to medication puts many at risk of HIV infection

Louise Prime

Wednesday, 06 September 2017

Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is both safe and well tolerated in young men who have sex with men, new research has shown. But the small study,* published in JAMA Pediatrics, also showed that the adolescent men’s adherence to the PrEP regimen – although very high initially – waned with time, putting some of them at risk of HIV infection.

US researchers commented that although PrEP using tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) was approved by the US Food and Drug Administration in 2012, and since then its effectiveness has been shown in clinical trials and demonstration projects, the trials have not included men younger than 18 – meaning that regulators did not consider approving TDF/FTC for this age group.

They designed an open-label demonstration project and phase 2 safety study trial, ‘Adolescent Medicine Trials Network for HIV/AIDS Interventions 113’, to assess the use of PrEP in men aged 15-17 years who have sex with men.

They recruited the study participants from adolescent medicine clinics and community partners in six US cities. All 78 participants had negative HIV test results at baseline, but were at high risk for infection and were willing to participate in a behavioural intervention and to accept TDF/FTC as PrEP. Their mean age was 16.5 years; 29% of them were black, 14% white, 21% white Hispanic and 33% were other/mixed race/ethnicity.

The participants were provided with TDF/FTC daily for 48 weeks. Over that period, 12 participants were diagnosed with a total of 23 sexually transmitted infections; and three participants acquired an HIV infection (equivalent to an HIV seroconversion rate of 6.4 per 100 person-years). Those men who seroconverted had serum levels of tenofovir diphosphate levels consistent with them having taken less than an average of two doses per week of the PrEP at the likely time of HIV infection.

The researchers reported that over the first 12 weeks of treatment, more than 95% of participants had detectable PrEP drug levels – but thereafter, drug levels declined. They found that tenofovir diphosphate levels consistent with a high degree of anti-HIV protection were found in 54%, 47%, 49%, 28%, 17%, and 22% participants at weeks 4, 8, 12, 24, 36, and 48, respectively. They pointed out that among adolescents generally, it is common to see challenges to medication adherence.

The study authors noted that their small study size was one of its limitations. They concluded: “The high incidence rates of HIV and STIs among young men who have sex with men, along with the lack of any significant safety signals from this study, strongly support the need for an adolescent PrEP indication for TDF/FTC. The waning adherence, especially with quarterly visits, demonstrates that more time, attention, and resources may need to be allocated to adolescents who are seeking prevention services. Developmentally appropriate visit schedules within adolescent-friendly service facilities will be important additions to PrEP implementation programmes.”

* Hosek SG, Landovitz RJ, Kapogiannis B, et al. Safety and feasibility of antiretroviral preexposure prophylaxis for adolescent men who have sex with men Aged 15 to 17 Years in the United States. JAMA Pediatr. Published online September 05, 2017. doi:10.1001/jamapediatrics.2017.2007.

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