T-PrEP
Research type
Research Study
Full title
The role of hepatitis B monotherapy in protection from HIV infection
IRAS ID
213017
Contact name
Julie Fox
Contact email
Sponsor organisation
Guy's & St. Thomas' NHS Foundation Trust
Duration of Study in the UK
0 years, 4 months, 29 days
Research summary
Cost-effective HIV prevention strategies are urgently needed. The use of daily oral Truvada for PrEP (Pre Exposure Prophylasis) has demonstrated efficacy and is licenced in the USA (FDA 2012). However, it is expensive and in March 2016, NHS England declined funding Truvada PrEP as cost effectiveness was not achieved driven largely by drug cost.
Tenofovir monotherapy is routinely used as treatment for Hepatitis B infection. This group of individuals therefore provides a unique setting to study this drug in HIV prevention. We think that tenofovir monotherapy at steady state will confer complete protection from HIV across both vaginal and rectal mucosa.
We propose a single-arm trial involving Hepatitis B positive (HIV negative) men and women receiving tenofovir monotherapy, attending for routine follow up. Participants will need to attend for one or two visits (depending on their preference and on if their eligibility has been confirmed). The protective effect of tenofovir therapy will be evaluated for HIV protection using an ex vivo (within a lab) challenge model of rectal tissue taken via proctoscopy and vaginal tissue taken via a speculum. By embedding this study of HIV within a Hepatitis B clinic, we have a unique opportunity to assess Tenofovir PrEP, putting individuals at no risk of HIV. As patients are receiving drug for clinical purposes, the study is cost effective as there are no drug costs. This simple study addresses key data gaps that are essential for the global rollout of PrEP which is critical for HIV prevention.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/2199
Date of REC Opinion
17 Jan 2017
REC opinion
Further Information Favourable Opinion