It has been a busy time for PrEP.
TDF/FTC Approved as PrEP in Europe
On 22 August 2016 the European Medicines Agency (EMA) finally granted approval for tenofovir DF/emtricitabine to be used as PrEP.1
As noted in the previous issue of HTB, this has come four years too late -- following initial active blocking by the EMA.2
The new marketing authorization allows use of TDF/FTC as PrEP in all 28 countries of the European Union, subject to national regulatory authority approval of required pharmacovigilance materials in each country.
In addition to the European Union, Truvada is also authorised for PrEP in Australia, Canada, Kenya, Peru, South Africa and the United States.
Update on NHS England Commissioning
The formal 45-day community consultation for NHS England to decide on PrEP ended in mid-September, with responses likely to run into several hundred submissions.
NICE is likely to formally publish results from the review in October and the results from the appeal by NHS England to the judicial review (that found the NHS has the authority to commission PrEP) is expected later in the month.
Gilead Reverses Decision to Allow Extended Access to PrEP for Participants in PROUD Study
On 2 September 2016, Gilead announced that participants in the UK PROUD study would be able to access PrEP for an additional three months.3
Earlier this year, when it became clear that NHS England were extending the timeline for considering access to PrEP, Gilead had refused appeals to provide additional PrEP to cover this shortfall.
This welcome change by Gilead is likely a result of continued pressure from the PROUD researchers and other community responses.
TAF PrEP Studies Underway in U.S.: UK Sites Due to Join Shortly Providing Other Access to PrEP
A large international double-blind phase 3 placebo controlled study will randomise 5000 HIV-negative people to either TDF/FTC or TAF/FTC. Some U.S. sites are already enrolling and 12 UK sites are planned.4
The primary endpoint for this study with a new formulation of TDF will be the number of new infections at 48 weeks, plus numerous secondary endpoints.
- Gilead press statement. European Commission Grants Marketing Authorization for Gilead's Once-Daily Truvada For Reducing the Risk of Sexually Acquired HIV-1. (22 August 2016).
- Collins S. EMA overcomes its own prejudice to approve PrEP in Europe: four years too late. HIV Treatment Biulletin (HTB) July/August 2016.
- Gilead donates drug for PROUD participants. ( 2 September 2016).
- Safety and efficacy of emtricitabine and tenofovir alafenamide (F/TAF) fixed-dose combination once daily for pre-exposure prophylaxis in men and transgender women who have sex with men and are at risk of HIV-1 infection. ClinicalTrials.gov Identifier: NCT02842086.