Comment: Abstract follows.

For me, this was one of the most interesting studies presented at CROI this year. It generated much discussion amongst delegates and took the post, rather than pre-exposure prophylaxis approach.

STI antibiotic prophylaxis is a topic that’s been discussed for decades. We’re all struggling to manage the rapid increase in STIs over the past two to three years. Risk compensation is alive and well and our many of our MSM patients frequently present between routine HIV or PrEP visits with symptomatic STIs.

As per my previous blog, the evidence to date for STI antibiotic prophylaxis is limited and the potential costs are high. Of some concern is that antibiotic resistance testing in this study, only pertains to STIs and not other relevant organisms such as malaria and those causing serious skin and respiratory infections.

 The abstract is listed below but I’ll end with Jean Michel’s conclusion slide:

 - PEP with doxycycline reduced the overall incidence of bacterial STIs by 47% in MSM on PrEP (8.7 months of PFU).

- No effect on Gonorrhoea but strong reduction (70-73%) in Chlamydia and Syphilis incidence.

- Acceptable safety profile with mild/moderate GI A/Es leading to discontinuation in only 7% of participants.

- No evidence of risk compensation.

- Analysis of antibiotic resistance pending (STIs only).

- Long term benefots of PEP yet unknown.

- Antibiotic prophylaxis for STIs still NOT RECOMMENDED.

- More research needed in the field of STIs.

91LB ON DEMAND POST EXPOSURE PROPHYLAXIS WITH DOXYCYCLINE FOR MSM ENROLLED IN A PREP TRIAL

Jean-Michel Molina et

Background: A high incidence of bacterial sexually transmitted infections (STIs) has been reported in several PrEP trials and demonstration projects among MSM. We wished to assess whether on demand post-exposure prophylaxis (PEP) with doxycycline could reduce STIs incidence in this high risk group.

Methods: High risk adult MSM being followed in the open-label phase of the ANRS IPERGAY trial with on demand TDF/FTC for HIV prevention, were enrolled in a prospective randomized open-label sub-study. Participants (pts) were randomized 1:1 to take either two pills of doxycycline (100mg per pill) within 72h after condomless sexual intercourse (without exceeding 6 pills per week) or no PEP. All subjects received risk-reduction counseling and condoms, and were tested every 8 weeks for HIV and STIs with serologic assays for HIV and syphilis and PCR assays for Chlamydia trachomatis and Neisseria gonorrhoeae in urine samples, oral and anal swabs. The primary study endpoint was the time to a first bacterial STI: gonorrhoea, chlamydia infection or syphilis. We compared the two study arms according to the intention-to-treat principle. We used time-to-event methods, including Kaplan–Meier survival curves and Cox proportional-hazards models.

Results: From July 2015 to January 2016, 232 pts were randomized, 116 in each arm. Median follow-up was 8.7 months (IQR: 7.8-9.7). Seventy-three pts acquired STIs during the study period, 28 pts in the PEP arm (24%, 37.7 events per 100 pt-years) as compared to 45 pts in the no PEP arm (38.8%, 69.7 events per 100 pt-years) for a hazard ratio (HR) of 0.53 (95% CI: 0.33-0.85, P=0.008). HR for gonorrhoea, chlamydia infection and syphilis were 0.83 (95% CI: 0.47-1.47, p=0.52), 0.30 (95% CI: 0.13-0.70, p=0.006) and 0.27 (95% CI:

0.07-0.98, p<0.05), respectively. Overall 71% of all STIs were asymptomatic. Pts in the PEP arm used a median of 7 pills/month (IQR: 3-13). Safety was good with only 8 pts (7%) discontinuing PEP because of gastro-intestinal adverse events (AEs). Gastrointestinal AEs were reported in 61 pts (53%) and 47 pts (41%) in the PEP and no PEP arms, respectively (p=0.07). There was no significant change in sexual behaviour between study arms during follow-up.

Conclusion: On demand PEP with doxycycline reduced the incidence of chlamydia infection and syphilis in high risk MSM and has an acceptable safety profile. The long-term efficacy of this strategy and its impact on antibiotic resistance needs to be assessed.

Symposium 5-3 ‘Strangers in the Night; Challenges and Opportunities in STI Control: provided a fascinating insight into potential opportunities and strategies for STI control. There was so much interesting and important information in the two hours of the session that I encourage to take the time to watch the whole webcast of this session.

R. Scott McClelland presented on the ‘Vaginal Microbiome and Susceptibility to HIV’ addressing the dynamic changes in the vaginal microbiome and the conditions, eg Bacterial Vaginosis, that can lead to morbidity and increased risk for HIV entry.  Jean-Michel gave a historical overview of the outcomes and opportunities for ‘Antibiotic Prophylaxis for STIs: Promises or Perils’ – you are left feeling that the risk of antibiotic resistance (eg as has occurred with gonorrhoea) is far too great for future intervention with prophylactic antibiotics for STIs.

Matthew Golden outlined the experience in USA (and Australia) in relation to the increasing rates of STIs in ‘Syphilis in the Era of Treatment as Prevention and Pre-Exposure Prophylaxis’.  He addressed the various changes in sexual behaviour eg serosorting, rates of condom use and sex in the era of PrEP and warned that we must address the increased rate of STIs, particularly syphilis in MSM, with renewed vigilance.  Lastly, Rebecca Guy from the Kirby Institute addressed the challenges of the ‘Scale up-of Point-of Care Tests for Sexually Transmissable Infections’ addressing the sensitivity of available tests, and their appropriate use.  Rebecca outlined the Kirby Institute’s projects in antenatal clinics in PNG and with community sexual health workers in remote Australia. The implementation of POC tests with the aim of treatment on the same day, by staff in those settings was outlined.

Looking at inequity and qualitative care data measures in UK for People Living with HIV min 2015, in the UK.

HIV – 98% diagnosed retain in care.

5-6 thousand new diagnosis yearly. 3,000 are gay men. 3,000 heterosexuals (people that acquired HIV abroad or late diagnosis, mostly new arrivals/immigrants).  

Most linked to care in first year of diagnosis

An early diagnosis in a high resourced country, shows similar lengths of life expectancy as the general population.

Many people feel (or experience) stigma and discrimination around social gatherings and settings.

Dental and Healthcare/GP’s are 2 areas the people living with HIV avoided.

Dr Gail Matthews, Sydney. HEP C Updates –

200,000 to 300,000 people living with HEP C in Australia.

2-3 thousand people living in Australia co-infected with Hep C and HIV.

Since the new Hep C Treatment begun 12% of the Hep C population.                             40,000 (20% of this Hep C population) expected to be treated by the end of 2016. Predominately genotype 1. Genotype 3 (less).

Updates to Census Guidelines for Hep C – 2016.

Gastroenterologists (Specialist) treatment rates have fallen to 50% with other Dr’s/Prescribers accounting for an increasing amount in March to June, 2016.

Possible Risk of HBV reactivation on DAA therapy. The risk levels are unclear. Prescribers can discuss with Specialist about Serology or treatment concerns.

CLOSING PLENARY - looking towards 2020!

President Elect Donald Trump accession in US and Global politics was discussed, with unanimous concerns of the possible impacts on marginalised groups, such as people living with HIV.

PEPFAR – is a major global initiative, assisting those with HIV/AIDS. It was thought funding may be less sustainable and diminished under Trump Presidency.

PrEP – Pharmaceutical Benefit Scheme - (PBS) Australia, hopefully rolled out next year. Need to target Aboriginal people, CALD Communities.                                                         There is an over-representation of ABSTI with HIV.                                                                     STI rates are climbing.  Condom use needs to remain as valued!

Partner with Aboriginal lead services to effect better outcomes for ABSTI Communities. Need high level engagement to focus on ABSTI chronic health conditions, mental health, HIV, STI’s and long term future funding arrangements.

ABSTI community lead primary healthcare in partnerships/collaboration with agencies.

Need better national co-ordination. Invite all stake-holders to assist in managing – Treatment as Prevention (PrEP) collectively.

Equitable care

Develop greater sense and involvement with communities.

Challenge the ‘spitting law’ that is been brought up by 3 states. This is NOT Evidence based practice. A motion agreed by all was held at the end of the Conference today.

Focus now needs to be on other priority populations, such as Woman and heterosexual males to be seen as a priority populations.

Develop internationally agreed best policy – basic guidelines of care and treatment.

There is a lack of engagement with governments and communities. This needs to change NOW!

Speak up and challenge funding cuts. We need to INVEST MORE.

Non-Aboriginal people to ‘speak up and be a voice’ for ABSTI plight and their needs.  

Migrants Medication and medical needs to be covered.  

Collaborate with local communities. How do we reach out to others less engaged?

What resources do we have and how can we mobilize them better?

Look towards Aboriginal Medical Service (AMS) for leadership in Primary Care delivery.  

Globally, The United Nations (UN) is under threats by been constantly undermined by States with vested interests.  

Next step in HIV care and treatment is a vaccine. Injectable is expected 4 + years away.

See you all in Canberra, ACT in November 2017 J

Current criminal law is lagging behind our latest understandings of how HIV is transmitted, and more importantly *not* transmitted.

Take for example law in the Northern Terratory. NT currently hosts a "spitting laws" that can allow for invasive HIV testing in instances of spitting. This is despite zero evidence to demonstrate potential HIV transmission via saliva.  It is clear that current judicial law Is well behind the evidence when it comes to public safety with regards to HIV transmission.

As part of this weeks ASHM conference 2016 a position statement has been launched to help guide law towards the latest research and medical data on the current risks of HIV transmission.

I applaude the release of this position and hope that this may be quickly picked up within our judcial systems moving away from legislation and towards eudcation and health based interventions.

http://theconversation.com/australian-law-needs-a-refresher-on-the-science-of-hiv-transmission-68225

https://www.mja.com.au/journal/2016/205/9/sexual-transmission-hiv-and-law-australian-medical-consensus-statement

Start treatment if not already on it.

Normal delivery if VL < 50, planned cesarean section for VL 50-399, add iv ZDU if VL > 400

714 infants born to 527.

No breast feeding.

Mean gestation was 38 weeks, mean maternal age at delivery was 30 years.

87% reported heterosexual exposure as the mode of transmission.

32% of infants were HIV infected after birth at the beginning of the time period studied, reducing down to 1.5% currently.

Maternal HIV diagnosis was made before parturition in 49% at the beginning of the period studied, compared with 98% currently.

In the last 10 years, there have been 11 cases of maternal transmission.

These were primarily cases where the maternal diagnosis was not known, or there were tolerability issues with maternal ARVs.

We have seen a substantial increase in numbers of children born to HIV positive mothers over the last 30 years.