Tuesday mornings Oral Abstract session was titled PreP: Demonstration for Implementation presented the initial findings from at least four studies into issues such as adherence and uptake. The studies examined some key affected populations.
Of particular interest was an abstract from the U.S about PreP in Young MSM (YMSM) and transgendered women by the adolescent trials network (ATN) study 110. YMSM are at particularly high risk of HIV acquisition and remain relatively understudied with respect to PreP.
The ATN 110 study has some locally relevant points.
ATN 110 was an open label study or once daily TDF/FTC across 12 U.S cities of men aged between 18-22.
The primary objectives were to
- provide additional safety data on FTC/TDF use in YMSM
- to examine the acceptability, patterns of use, rates of adherence and drug levels when YMSM are provided open label Truvada and
- to examine patterns of sexual behaviour when YMSM are provided PreP
The 200 enrolled participants had self-reported high sexual risk in the last 6 months and were HIV negative.
The mean age of participants was 20 years, 78% identified as gay, more than 80% reported condoles anal intercourse in the last six months, almost 60% receptive anal intercourse and 22% were positive for an STI at screening. More then 50% were black.
There were very few adverse events but 25 discontinued primarily due to personal choice or a self perceived change in their sexual risk.
Study participants were incentivised $25 per visit and had study visits at weeks 4,8,12; then three monthly.
There were 4 seroconversions by week 48. All four had undetectable levels of Truvada, None of them had drug resistant virus.
Generally, participants reporting higher sexual risk had higher levels of Truvada. This remained consistent though to week 48. The mean number of parterns and condomless sex acts was mostly unchanged. STI rates remained as high as there were at baseline.
Notably, adherence decreased for all participants over the 48 weeks. Adherence appeared to decrease as the study visits decreased in frequency. Some qualitative research will be done some time in the future. This could infer that YMSM may need more rigorous follow up or an ‘enhanced visit schedule’
Wednesday’s Plenary will further examine PreP