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Results of the PrEP PROUD study are published

PrEP should be routinely offered now as part of sexual health services, says editorial

 

Gay couples in civil marriage, love and relationship

The results of the HIV pre-exposure prophylaxis (PrEP) study using the daily dose tenofovir plus emtricitabine (Truvada) from the PROUD study have now been published in the scientific journal The Lancet. PROUD, along with another European randomized study of PrEP, Ipergay, demonstrated considerably higher levels of effectiveness of PrEP in preventing HIV infections than any previous study. The results of both studies were presented in February this year at the conference on retroviruses and opportunistic infections (CROI 2015).

There is little difference between the results in The Lancet and which would be presented at CROI but newspaper publishing is important to provide PrEP in Europe as both European agencies of medicines, the European Agency drug (EMA), which regulate the licensing drugs, and the European Centre for Disease Prevention and Control (ECDC), which issues public health recommendations, both require the publication of studies of newspaper to be included in their evidence.

There were subtle differences. A statistically significant change in behavior in PrEP men has been detected by researchers (an increase in the proportion of men who had high numbers of partners without a condom as the receptive partner) but on the other hand, is more clear than before no change the incidence of sexually transmitted infections (STIs), when men began to PrEP.

The effectiveness of PrEP in PROUD remains at 86% (which means, that is to say, that PrEP prevented about 17 infections in each niche from 20 likely HIV infections that would have happened otherwise), and the number of men needed to be treated with PrEP to prevent HIV infection remains at 13. However, the lower limit of the 90% confidence interval for the effectiveness of PrEP has shifted upward from 58 to 65: what this means is that there is one less of a possibility of contagion in a frame of twenty possibilities of contagion whenever the study was repeated, PrEP would prove to be more than 65% effective.

Demography remains almost the same as those reported in April 2014 when recruitment was complete: 544 men were enrolled in clinical 13 sexual health in England: 275 were randomly assigned to take daily Truvada as PrEP immediately and 269 to wait a year before starting it.

Three HIV infections were observed in men allocated to start preparing immediately, but one of these almost certainly contracted HIV before PrEP started (he was tested HIV-positive on his second visit a month after starting), while the others two had stopped taking PrEP months before they contracted the AIDS virus.

There were also three men (not six as stated in the aidsmap.com February play) who tested HIV-positive on their first clinical visit, on the day they went to receive PrEP for the first time and must have contracted it at most 2-3 weeks before.

Two of the men who started PrEP while they already had HIV, including diagnosed on his second visit, had developed resistance to emtricitabine: no one developed resistance to tenofovir.

In contrast 20 (not as originally thought 19) men in the deferred arm contracted HIV during the year they were waiting for PrEP to start and this means that the observed annual HIV incidence slightly changed to 9% in the deferred arm and 1.2% on the immediate arm. The 9% incidence seen in the deferred arm is very high; more or less seven times greater than the 1,34% seen in homosexual men who attend English sexual health clinics in 2012.

This underlines that the men who came forward or were referred to the PROUD were a highly selected group of gay men at higher risk.

Another fact supporting this is that 64 of the study participants had an STI diagnosed in the year before joining the study - an aggregate figure that has not been reported in BHIVA Spring 2014 conference when judgment based Demographics were presented (only the numbers individual been reported STD).

This means that there clearly was no increase in STIs in participants taking PrEP: 57 immediately and 50 arm in the deferred arm were, respectively, an STD diagnosed during the study, but because men in the immediate arm had more tests, after adjustment this is just a difference in 7pessoas, which is not statistically significant. In particular, after adjustment there was no difference at all in the third of the men who took a rectal bacterial STDs, the most sensitive indicator of being the receptive partner bareback anal sex, which is 17 times riskier than being the active partner when it treat HIV infection.

There was a statistically significant difference in behavior. During the study, a greater proportion of participants in the immediate arm PrEP reported receptive anal sex without a condom with ten or more partners in the three months preceding that participants in the deferred arm (21 against 12, 0,03 probability). However when this was an increase over the baseline did not translate into more STDs and the number of partners with whom participants had anal sex did not change.

The researchers conclude: “Our results strongly support the addition of preparation to the prevention standard for men who have sex with men at risk of HIV infection.” In editorial follow-up, PrEP researcher Ken Mayer of Fenway Health in Boston, USA and Chris Beyrer, President of the International AIDS Society, commented: “PROUD results suggest that pragmatic implementation of preparedness should be part of any relevant primary HIV prevention strategy… PrEP should be part of the range of services offered by any clinical program that focus on sexual health. The time for preventive speculation is over: HIV prevention services must expand worldwide, offering PrEP routinely to those who could benefit. “

Gus Cairns

Published: 14 September 2015

Translated and revised from the original in PROUD PrEP study results published by Claudio Souza on the 17 night of September of 2015

E References

McCormack S et al. Pre-exposure prophylaxis to Prevent the acquisition of HIV-infection 1 (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomized trial. The Lancet, early online publication. IT HURTS: http://dx.doi.org/10.1016/S0140-6736(15)00056-2 2015.

Mayer KH and Beyrer C. Antiretroviral chemoprophylaxis: PROUD and pragmatism. The Lancet, early online publication. IT HURTS: http://dx.doi.org/10.1016/S0140-6736(15)00153-1 2015.

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