Transgender women taking PrEP have lower levels of PrEP drugs than cisgender men

aidsmap/nam, November 9th 2018

A study presented at October’s HIV Research for Prevention conference (HIVR4P) in Madrid shows that transgender women who are taking feminising hormones and also taking pre-exposure prophylaxis (PrEP) have levels of the PrEP drugs tenofovir and emtricitabine in their blood that are about 25% lower than those in cisgender men, and levels in rectal tissue cells about 40% lower. Tenofovir levels in rectal tissue were 44% lower.

However, the study also confirmed that the interaction between hormones and PrEP did not appear to go the other way; blood levels of estradiol, the one hormone all of the transgender women took in one form or another, do not appear to be affected by PrEP.

 

HIV PrEP available on PBS in Australia from 1 April / Links to Clinical Resources

Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM), 21 March 2018

ASHM congratulates the Federal Health Minister, the Hon. Greg Hunt’s announcement of a landmark in HIV prevention to approve HIV-prevention drugs – tenofovir with emtricitabine, known as PrEP – on the Pharmaceutical Benefits Scheme from 1 April, thereby providing broader access for any doctor or general practitioner to be able prescribe PrEP to an Australian resident who holds a current Medicare card.

“The public health benefits are clear, undeniable and transformative benefiting individuals at medium- to high-risk of HIV infection and towards driving a substantial reduction in HIV transmissions in Australia,” said ASHM President, Associate Professor Bloch.

Access Links to Clinical Resources supporting the HIV workforce

  • The definitions of risk for HIV, guidelines and procedures for the appropriate administration and monitoring of PrEP can be found here: ASHM HIV pre-exposure prophylaxis: clinical guidelines
  • The Australian Federation of AIDS Organisations (AFAO) and ASHM have produced a PrEP Fact Sheet to assist PrEP users and people with an interest in using PrEP to understand what subsidised access to PrEP through the PBS means. Access the factsheet here
  • ASHM continues to support the workforce to ensure access to PrEP and best practice in guidelines, training and resources. Access information here
  • The Pharmaceutical Society of Australia has a range of training to support pharmacists in preparing for PrEP on the PBS: www.psa.org.au

 

Expanded HIV PrEP implementation in communities in NSW (EPIC-NSW): design of an open label, single arm implementation trial

BMC Public Health 
https://doi.org/10.1186/s12889-017-5018-9

 Published: 2 February 2018

Abstract:

Background

The New South Wales (NSW) HIV Strategy 2016–2020 aims for the virtual elimination of HIV transmission in NSW, Australia, by 2020. Despite high and increasing levels of HIV testing and treatment since 2012, the annual number of HIV diagnoses in NSW has remained generally unchanged. Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection among gay and bisexual men (GBM) when taken appropriately. However, there have been no population-level studies that evaluate the impact of rapid PrEP scale-up in high-risk GBM. Expanded PrEP Implementation in Communities in NSW (EPIC-NSW) is a population-level evaluation of the rapid, targeted roll-out of PrEP to high-risk individuals.

Methods

EPIC-NSW, is an open-label, single-arm, multi-centre prospective observational study of PrEP implementation and impact. Over 20 public and private clinics across urban and regional areas in NSW have participated in the rapid roll-out of PrEP, supported by strong community mobilization and PrEP promotion. The study began on 1 March 2016, aiming to enroll at least 3700 HIV negative people at high risk of HIV. This estimate took into consideration criteria for PrEP prescription in people at high risk for acquiring HIV as defined in the NSW PrEP guidelines. Study participants receive once daily co-formulated tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and are followed for up to 24 months. Follow-up includes: testing for HIV at 1 month, HIV and other sexually transmissible infections three-monthly, HCV annually and monitoring of renal function six-monthly. Optional online behavioural surveys are conducted quarterly. The co-primary endpoints are (i) HIV diagnoses and incidence in the cohort and (ii) HIV diagnoses in NSW.

Discussion

EPIC-NSW is a population-based PrEP implementation trial which targets the entire estimated population of GBM at high risk for HIV infection in NSW. It will provide a unique opportunity to evaluate the population impact of PrEP on a concentrated HIV epidemic.

The updated 2017 ASHM HIV pre-exposure prophylaxis (PrEP) Guidelines

Journal of Virus Eradication, 2017; 3: 168–184

Daily use of co-formulated tenofovir and emtricitabine for HIV pre-exposure prophylaxis (PrEP) by populations at high risk of HIV infection is now recommended in guidelines from the United States, Europe and Australia and globally through the 2015 WHO guidelines. 

These 2017 Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine‘s (ASHM) PrEP Guidelines are an updated adaptation of the 2014 US Centers for Disease Control‘s PrEP guidelines and are designed to:

    • Support the prescription of PrEP using forms of coformulated tenofovir and emtricitabine that have been registered in Australia by the Therapeutic Goods Administration and other bioequivalent generic drugs that are available in Australia through self-importation, private prescription or Australian PrEP clinical trials
    • Assist clinicians in the evaluation of patients who are seeking PrEP
    • Assist clinicians in commencing and monitoring patients on PrEP including PrEP dosing schedules, management of side-effects and toxicity, use of PrEP in pregnancy and in chronic hepatitis B infection and how to cease PrEP

Daily PrEP with co-formulated tenofovir and emtricitabine, used continuously or for shorter periods of time, is recommended in these guidelines as a key HIV-prevention option for men who have sex with men (MSM), transgender men and women, heterosexual men and women, and people who inject drugs (PWID) at substantial risk of HIV acquisition.

UK report gives thumbs up to generic HIV drugs used as PrEP

A sexual health clinic in London has tested drug levels in users of generic PrEP medication bought online and found the drugs are genuine and effective.

Tests found adequate levels of both emtricitabine and tenofovir (used in PrEP medication Truvada) in patients’ blood, and no sample suggesting counterfeit drugs.

London sexual health clinics step up their support for people buying PrEP online

nam/aidsmap, 29 January 2016

Several large sexual health clinics in London and Brighton have responded to the growing numbers of people importing PrEP medications from overseas by offering free safety monitoring to PrEP users. This is in a context of increasing frustration with the slowness of the official NHS process to approve PrEP – no decision will be made until June at the earliest.

  • Read more here
  • See the Getting Your PrEP Online support page from Chelsea and Westminster Hospital here
  • See UK PrEP advoacy pages here and here
  • See an Australian PrEP advoacy page here