ASHM Report Back

Clinical posts from members and guests of the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) from various international medical and scientific conferences on HIV, AIDS, viral hepatitis, and sexual health.

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Daily dosing for PrEP seems to be taking precedence over other dosing schedules. This was cast into some doubt when the IPERGAY and PROUD studies were presented at CROI revealing and 86% reduction in transmission for both daily and event driven PrEP. But discussion about frequency of dosing remains. HPTN067 the ADAPT trial reported 2 of 3 arms comparing daily, twice weekly + one dose after event and one dose before and one dose after event dosing. The sites were Harlem and Bangkok. Daily dosing was best in both studies. Doses after sex event were most frequently missed. No risk compensation.

Less than daily dosing is probably effective at some level, but determining that level is the challenge. Having sufficient drug on board to maintain an effective therapeutic dose is the issue and this may be impacted by other host factors such as weight and metabolic rate. If 3 or 4 doses are sufficient to provide protection then this would provide significant cost savings against the cost of Truvada

On the topic of risk compensation, a passing comment was made that if anyone is going to see risk compensation and reduction in condom use it will be the Australians as they are the only people who use condoms.

The PROUD and IPERGAY studies offer us 2 dosing options for effective HIV prevention in high risk MSM:

1. Daily Truvada (Tenofovir/ Emtricitabine) 1 tablet

or

2. On- demand Truvada at the time of sexual exposure as follows:

- 2 tablets 2-24 hrs before sex

- 1 tablet 24 hrs later

- 1 tablet 48 hrs later

( if additional sexual encounters then continuing the regime so that 2 tablets over 48 hrs are taken after the last sexual encounter)

With the addition of PEP provided on-demand

Some additional considerations:

  • Adherence to PrEP is obviously critical to its effectiveness
  •  Condom use should continue to be promoted. Although neither study showed an increase in incidence of STIs in the PrEP group there is an ongoing concern that increased risk taking behaviour on PrEP will increase STI incidence.
  • Side effects- most commonly GIT - nausea, diarrhoea, less common- headache, renal
  • Renal monitoring- baseline and ongoing (? Frequency)
  • Baseline and ongoing HIV and STI testing ( 3 monthly)
  • Possible targets for PrEP- High risk MSM. For example anyone- with an STI in the last 6 months, in a HIV discordant relationship, who has unprotected anal sex, who use recreational drugs and/or binge drinks.
Tagged in: croi2015 PREP PROUD

Three exciting and anticipated papers were presented in the Oral session #1 this morning.

Sheena McCormack (abst 22LB)presented the PROUD study, which was designed to see if previous results could be achieved in a "real world setting", 539 people were randomised to 2 years once daily dosing with Truvada and 545 to a one year delayed therapy arm. The study was stopped late last year due inferiority in the deferred arm. There was an 86% reduction in transmission in the treatment arm and the three seroconversions is this group were probably infected or sero-converting at the outset. There were few side effects and the study population was at high risk of HIV.

Jean-Michel Molina presented IPERGAY (abst 23LB) this study looked at "on-demand PrEP" to see if efficacy achieved in macacques treated before and after exposure could be achieved in a real-world setting. The regimen was 2 pills 2 - 24 hrs before sex, one after sex and a further pill 24 hrs after the first dose. If there was more than one encounter the daily PrEP was prescribed. The results were also an 86% reduction in transmission and transmissions were again observed in participants who were either infected at the start or who had ceased taking drug. This is a very important study as it provides an option for people who have only limited high risk exposures. Side effects were minimal and stopped when the drug was ceased. Importantly from a cost effective standpoint. 18 pills per year were required to avert and infection and the average was 16 pills per month or 4 pills per week. This study will require close further scrutiny and could be a game changer.

Bob Grant (abs #25), from the San Francisco AIDS Foundation looked at what would be required to achieve transmission reduction targets. He found a combination of PrEP, increased treatment and testing together had the greatest impact. Importantly he reported that people who were taking PrEP were at high risk. Other were interested in taking it or interested but wanted more information. These people were eligible and given access had the potential to drive down infection rates.

The talks are available on line at http://www.croiwebcasts.org/ I really suggest considerable attention is given to this important session.

 

Tagged in: croi2015 PREP PROUD

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