||"Gabriel, ADEYEMO" [ profile ]
The road to PrEP: Trials, regulation and roll-out
Jul 2nd, 2012 - 04:49:36
AUTHOR: Gus Cairns
Within the next three years, up to 33,000 people may take part in 22 different studies worldwide to demonstrate the feasibility, or otherwise, of pre-exposure prophylaxis (PrEP) to prevent HIV, the IAPAC evidence
summit, Controlling the HIV epidemic with antiretrovirals, was told on 12 June...Dr Jim Rooney of Gilead Sciences, the manufacturer of tenofovir (Viread) and Truvada (tenofovir and FTC), the products being tested in the
vast majority of these studies, told the meeting that up to 13,000 men who have sex with men (MSM) could end up being involved in 14 different studies and up to 19,500 heterosexual men and women in eight studies...
Some of these are ongoing or open-label extensions of studies such as Partners PrEP in 4758 sero-different couples in Kenya and Uganda, or iPrEx OLE (Open Label Extension) in 1,500 MSM in six countries. Others are just beginning, such as the IPERGAY study of intermittent PrEP in gay men in France. While it is planned that this could eventually include 1,900 men, researcher Bruno Spire told the IAPAC meeting that...recruitment had been
rather slow so far, partly because of "ideological obstacles" to there being a placebo arm.
Similarly, Dr Sheena McCormack of the UK's Medical Research Council told the meeting that, while the planned UK PROUD study of immediate versus delayed PrEP could eventually include 5000 MSM, only a pilot project in 300 MSM has so far been proposed, with a tentative start date...in October
2012. In the US, nine studies in 4255 MSM are planned; these include specific studies amongst African-Americans and adolescents...
Similarly in South Africa, a small study called CHAMPS will recruit 100 male and female teenagers aged 14 to 18. Also in South Africa, a second - or rather third - study of a vaginal microbicide, FACTS, will recruit 2,200
women aged 18 to 30 and possibly another 400 aged 30 to 40. The study will aim to confirm the efficacy demonstrated in the CAPRISA 004 study, after the failure of the tenofovir-gel arm of the VOICE study to do that. A smaller study will look at safety and acceptability in 15- to 17-year-olds.
Jim Rooney also looked at the regulatory environment. The US Food and Drug
Administration voted for approval of tenofovir/FTC (Truvada) as PrEP in May
this year but confirmation, expected in September, is subject to a Risk Evaluation and Mitigation Strategy (REMS) document. In Europe, Rooney said, Gilead had been in talks with the European Medicines Agency (EMA) but specific plans for authorisation had not been finalised and at present the
EMA has issued a draft of a so-called 'reflection paper' on the general requirements for licensing HIV drugs for prevention: comments and feedback are welcome until 30 June.
Rooney said that plans were in place to file for authorisation in Africa, Latin America and Asia following the FDA review. He shared what the wording of an indication for PrEP might look like... There would not be a different, prevention-specific formulation of Truvada (this had been suggested in some quarters as a way to avoid informal use) and Gilead would
support the manufacture of generic versions of PrEP for resource-poor locations, as it does for treatment.
Gilead was prepared to work with PEPFAR, the Global Fund and the World Health Organization, but so far no decisions had been taken about PrEP roll-out in lower-income settings, Rooney said, and added that Gilead was drafting educational materials for potential users of PrEP. As for future PrEP developments, Jim Rooney said that Gilead was studying the PrEP potential of its new prodrug of tenofovir GS 7340, and even of drugs that could be specifically used for prevention: trials were already underway or
beginning of the entry inhibitor maraviroc (Celsentri) plus or minus tenofovir and/or FTC, as PrEP.
Moderators' Comment: This is somewhat an interesting article as it keep us abreast of upcoming trials and what we should be expecting. I think i am personally excited with this piece as it should make up part of my week to a greater length. You can click on the link above to read full text.
Have a nice week
Yours' in Prevention Science
Regional Focal Point - West Africa
Global Youth Coalition on HIV/AID (GYCA), a program of the Public Health
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