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Long term follow up of PROUD
Evidence for high continued HIV exposure and durable effectiveness of PrEP
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Reported by Jules Levin
IAS, 23-26 July 2017, Paris, France
E.White, D.Dunn, R.Gilson, A.Sullivan, A.Clarke, I.Reeves, G.Schembri, N.Mackie, C.Dewsnapp, C.Lacey, V.Apea, M.Brady, J.Fox, S.Taylor, J.Rooney, M.Gafos, N.Gill, S.McCormack,
and the PROUD study group
abstract
Background: The PROUD trial clearly demonstrated the clinical effectiveness of TDF/FTC in the first year of use. The continued follow-up of participants on PrEP (range 2-4 years), which included regular testing for HIV and other STIS, allows assessment on whether effectiveness is maintained in the longer term and the extent of potential exposure to HIV.
Methods: PROUD was a pragmatic trial in which MSM were randomised to receive daily TDF/FTC either immediately (IMM) or after a deferral (DEF) period of 12 months. Main efficacy findings were based on follow-up during the deferred phase when IMM had access to PrEP and DEF did not. Since Nov 14, when all participants were offered PrEP, the trial has entered a post-deferred phase. We compare incidence rates of HIV and selective STIs during the deferred and post-deferred phases.
Results: 524(269 IMM, 255 DEF) and 449(244 IMM, 205 DEF) participants contributed to the deferred and post-deferred phases. Of 368 who attended a clinic in the last 6 months of follow-up, 327(89%) had at least one PrEP prescription. HIV and rectal gonorrhoea(rGC)/chlamydia(rCT) incidence in each phase is shown by group in the table.
There was no difference in HIV incidence between the groups in the post-deferred phase (p=0.18), but a significant decrease in the DEF group once they had access to PrEP (p< 0.0001). The rate in the IMM group remained similar in the two phases (p=0.66). The incidence of rectal infections was high in both groups and phases. rCT was lowest in the DEF group during the deferred phase, and this was driven by those who did not report rCT in the year before enrolment.
Conclusions: The reduction in HIV incidence in the DEF group confirms the remarkable effectiveness of TDF/FTC. The relatively stable incidence in the IMM group indicates this effect is durable. High ongoing incidence of rCT/rGC shows that participants remained at high risk of HIV and this needs to be taken into account when planning PrEP provision in public health programmes.
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