ASHM Report Back
Clinical posts from members and guests of the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) from various international medical and scientific conferences on HIV, AIDS, viral hepatitis, and sexual health.
Updates from PREP Trials
IAS2017 Tuesday 11 am 25/7/2017
This session provided updates from various oral, topical and long-acting injectable PrEP clinical trials.
Sheena McCormack presented long-term PROUD study data from 2-4 years post enrolment. This indicated that reduction in HIV incidence was sustained, and confirmed high adherence and durable effectiveness of PrEP in the study population. However, as suspected rectal chlamydia and gonorrhoea and syphilis diagnoses remained high re-iterating the need for structured regular followup of these high risk patients.
A qualitative analysis exploring PrEP perceptions among PROUD participants, found that most viewed PrEP as a temporary HIV prevention option. Participants described psychosocial benefits in terms of reducing fear and providing relief when taking PrEP. They didn’t discuss some of the stigma that still persists in the community about people who take oral PrEP however. Acceptability seems to be increasing however.
Guillemette Antoni presented data from a double-blind, randomised sub-study of IPERGAY which found a significant reduction in HIV infection risk with on-demand TDF/FTC vs. placebo, in MSM having infrequent sex. Oral PrEP with tenofovir/emtricitabine is now subsidised in France.
Sharon Hillier presented data from the completed FAME study. This study found that FGT and plasma drug levels of dapirivine were not affected by Lactobacillus or G. vaginalis microbiome. Tenofovir levels in FGT and plasma however are adversely affected by vaginal disbiosis (bacterial vaginosis). The potential influence of vaginal microbiome on topical and plasma PrEP drug levels emphasises the need for HIV prevention products that work in women with vaginal dysbiosis.
Ian McGowan from the USA presented data from the MWRI-01 multi-dose Phase I study. They found long-acting IM rilpivirine to be safe. Drug accumulation was significant in plasma, rectal, and female genital tract (FGT) tissue.
Finally, Raphael Landovitz presented data from HPTN077, a double-blind, randomised, placebo-controlled tolerability and pharmacokinetics trial. They found LA cabotegravir was well tolerated at 800mg/600mg doses in HIV-uninfected low-risk males and females.
Updated safety, acceptability and pharmacokinetic data on LA IM rilpivirine and cabotegravir provides hope for the viability of long-acting injectable PrEP formulations and circumvention of the adherence challenges associated with oral or topical PrEP.