Some data from the Opposites Attract Study was presented by Ben Bavinton of the Kirby Institute this afternoon. Probably well known to most readers this longitudinal study is examining HIV transmission and viral load in serodiscordant gay relationships. This data continues to be collected and wasn’t presented today. What was shown was data relating to whether  seordiscordant couples were having condomless anal intercourse when the positive partner’s viral load was perceived to be undetectable. The study includes  couples in Australia, Brazil and Thailand. Most of the positive partners in Australia and Brazil are on treatment with an undetectable viral load.

 

Two thirds of  Australian couples and just under half of Brazilian couples were not using condoms.  There was a strong association in Australia between this behaviour and the perception by the negative partner that the positive partner’s viral load was undetectable. This association was not evident in Brazil or Thailand. There is evidence therefore that Australian couples are comfortable with the Treatment as Prevention message. Ben thought that the reason for the high association in Australia compared to the other two countries was very likely due to the widespread discussion in the community around the issue, better understanding of the new findings and good communication with healthcare workers ,etc.

 

Another really interesting study in the same session looked at another seroadaptive behaviour seen in Seattle MSM at a Sexual Health Clinic.Researchers sought to examine whether HIV negative men were having condomelss anal intercourse based on the timing of when their casual partner reported having their last test. 86% participants reported  asking when the partner had last tested. Two thirds of participants had then chosen not to wear a condom on the basis of the answer.

 

A similar number of negative men had reported asking potential positive partners about what their viral load was. 83% decided not to use condoms on the basis of this.Those who did ask their partner about testing were less likely to then test positive for HIV but the numbers who tested positive for HIV were very small in this study so I’m not sure of the siginifcance.

 

 

Just to add to Bk’s post…. In each site for HPTN 062   qualitative research in the form of in depth interviews were carried out with some participants. Rivet Amico found that in Africa, women’s adherence very much had to do with their trust/mistrust of the study drug. When they were suspicious they had low adherence. When they had confidence the drug worked, when  they felt they had ownership  of the study they had good adherence. Stigma played an important role in adherence in Bangkok and Harlem. Participants were viewed as either being HIV infected or sexually promiscuous if seen taking the drug. On the other hand for some participants it greatly relieved the anxiety of HIV acquisition and gave them a sense of freedom. One participant who had come of age during the AIDS epidemic commented that this was the first time in his sexual life he had ever felt truly free. This freedom from anxiety has been something which many of the participants on the Prelude Study that I have met have commented on also.

 

In addition to the PK data BK presented there were interesting differences in the PK data between rectal and vaginal mucosa. Concentrations of TDF-DP were 10-100 times greater in the rectal tissue compared with vaginal tissue after a similar dosing period. Time to reach peak concentration was also slower in the cervix compared with rectum. The reason for lack of protection in the studies such as FEM-PREP was explained by lack of adherence but perhaps this also has something to do with it.

 

Francois Venter from South Africa gave a great plenary yesterday about Biomedical Interventions : Contrasting Implementation Changes. He called for less moralising from politicians in his country and more accountability when it comes to the issue of young women in his country being infected by older men. Stop talking about the morality of it and act by keeping the girls at school- an intervention which has shown makes  a difference.

 

 

For those of you who see HIV affected couples who are considering pregnancy I attended an excellent symposium on the subject  yesterday.

 

Pietro Vernazza from Switzerland gave an overview on the science of safe conception strategies. Data from HTPN052 has obviously really transformed the information we can now give patients. We shouldn’t underestimate the power this news has for couples who believed they could never have a family or felt they were taking great risks if they tried.

 

 Nelly Mugo from Kenya spoke about her experiences in a study of close to 2000 serodiscordant couples using PrEP (Tenofovir and TDF/FTC). The study found no differences in pregnancy indcidence, preterm birth or infant growth in the first year of life when comparing the PrEP group with placebo. It is an important option for those women who’s partner has not yet started ART. Pietro Vernazza thought it was an unnecessary addition however for those women whose partners were on treatment even given the fact that these men may ocassionally have viral blips.

 

Elaine Abrams from Columbia University then discussed Unanswered Questions about ART and Pregnancy.  There were 1.5 million HIV infected pregnant women in 2014, with 1.3 million of those in subSaharan Africa. 73% of them were receiving ART. Important points were that since the change in WHO Guidelines in 2013 regarding the use of Efavirenz as first line ART in pregnant  women ( including those in the first trimester and women of child bearing age) there has been no subsequent uptick in the rates of congenital anomalies . This is reassuring and significant given the  hundreds of thousands of women who have taken it in the last couple of years.

 

Also, there have been approximately 18 large studies looking at ARVs and preterm birth. There does seem to be some association with prematurity but it is not severe. It appears to be mostly associated with PI use and if it is started preconception it seems to be associated with increased risk.

 

Can I bring to your attention the following website www.hiveonline.org. . Shannan Weber, the director of HIVE, a clinic in San Francisco which cares for HIV infected pregnant  women, gave a really inspiring and personal talk about some of the people she has assisted in having families. There are some great resources for patients on the website including a really practical one about Home Insemination.

 

TasP and PrEP have radically changed the experiences of those couples affected by HIV who want to have children. How great it is to be able to offer them such positive information.

 

 

 

 

 

Greetings  from Vancouver where the weather ( I am sorry to make you jealous) is absolutely gorgeous.

 

An interesting  satellite session on Rectal Microbicides, presented today by the Microbial Trials Network (MTN). Despite the proven effectiveness of PrEP there is still enthusiasm from sectors of the community for continued development of this alternative prevention tool. Not all MSM will be able to or want to take daily Tenofovir/FTC. Anal sex is also widely practiced by heterosexual couples particularly in Africa so there is much potential for use by these couples for the same reasons  vaginal microbicides are important.

 

The first ever Phase II trial to assess safety and acceptability of a rectal microbicide, MTN017 has just  been completed and was discussed by protocol chair Dr  Ross Cranston of University of Pittsburgh. Subjects were MSM and transgender females in multiple global locations

 

There were three treatment arms –

 

1.daily oral TDF/FTC

 

2.daily rectal reduced glycerin (RG)  tenofovir 1% gel (Phase 1 studies of ordinary tenofovir 1% gel found that when applied rectally it was associated with siginificant bloating, abdominal pain and diarrhoea. A reduced glycerin preparation was made which caused less osmosis in the rectum)

 

 or

 

3. RG TFV 1% gel used only before and after sex.

 

 Alll participants trialled all three methods and reported back on likelihood of ongoing use and ease of use. Data will likely be published in Feb 2016.

 

Several interesting ethical questions about the conduct of rectal microbicide trials  were raised by  Dr Ndebele of Medical Research Council of Zimbabwe. Most importantly, now that PrEP has proven to be so effective, should it also be provided as part of the comprehensive prevention package to trial participants, along with condoms and counselling regarding safe sex ?

 

I tend to think it should, as did most of the rest  of the audience, given UNAIDS Guidelines on ethical standards for HIV Prevention trials state “ participants should be offered state of the art risk reduction methods as they become available.”

 

This obviously raises many issues such as

 

- impact of cost

 

- the ethics of providing PrEP to participants in countries where there is little chance it will be available anytime soon and then withdrawing their access at the end of study and

 

- if uptake of PrEP were high amongst participants it would seem unlikely that you would be able to assess the efficacy of the microbicide.So what’s the point !

 

Dr Ian Mc Gowan another lead investigator discussed likely future directions for the MTN. This includes attempting to find a gel which could be used as a lube rather than inserted with the unpopular applicator currently used. The possibly of developing an alternative drug dapavirine which is more potent than tenofovir was also discussed.

 

The session wrapped up with a panel discussion between community representatives from the trial sites in the US, Canada and South Africa.

 

 They discussed

 

- how important  the development of rectal microbicides was for them as an alternative method for HIV prevention

 

- the importance of getting the product right so that it was an acceptable alternative

 

-the need for researchers to engage and invest in the community so that community members can participate meaningfully in trials  and

 

-the need for a gel that could be used both vaginally and rectally, being  useful for women for both types of sex and also to avoid the stigma for MSM in many countries when buying a product that idenitfied them as being engaged in anal sex.

 

It will be interesting to see how the MTN  goes. There are significant challenges and probably some sectors who will be sceptical of the need for rectal microbicides. However the more choices people have the better I think !

 

Slides for some of these presentations available on the IAS2015 website by clicking on the session on the Programme at a Glance.