After 38,000 Sex No HIV was transfered -PARTNER Study

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HIVThe recently Published PARTNER study showing the impact of HIV treatment (ART) on reducing transmission which  shows zero transmissions from over 58,000 individual times that people had sex without condoms

SEE THE RESULTS OF THE STUDY AS PUBLISHED

Of 1166 couples enrolled, 1004 couples had at least one follow-up visit and 888 couples provided 1238 couple years of follow-up (median 1.3 years (IQR 0.8 to 2.0) per couple. This included 548 heterosexual (HT) couples and 340 gay male couples. The main reasons for data not being included in the follow-up analysis was: not yet reaching first follow-up visit (n=162), lack of HIV test (n=20), use of PEP or PrEP (n=9), no condomless sex (n=15), viral load >200 copies/mL (n=55) and lack of viral load result (n=17). There were no significant differences between couples who contributed to follow-up data compared to those who didn’t.

Although 11 people became HIV positive, none of these infections were phylogenetically linked transmissions. This was after at least 58,000 distinct times when couples had penetrative sex without condoms.

 

 

Baseline demographics were reported — as with all results — by categories of HIV status, gender and sexuality, with some differences between groups. This makes summarising results complex, but the median age ranged from 40 to 44 (with IQR overall ranging from 31 to 50 years). Gay men and HT women were a few years younger than HT men. Approximately 80% of the HT men were white compared to 70% of women and 90% of gay men. A higher percentage of gay men had education to college/university or higher (approximately 50% compared to 19% to 35% for heterosexuals. Although some of these differences were significant, other than there were fewer very young adults involved, they reflect the diversity of people living with HIV.Image result

HIV positive partners had been on ART for a median of 10.6 (IQR: 4.3 to 15.6), 7.5 (IQR: 3.3 to 14.2) and 4.8 (IQR: 1.9 to 11.4) years, for HT men, HT women and gay men respectively. At baseline, couples reported having had sex without condoms for a median of 2 years (IQR 0.5 to 6.3), with differences between groups. For example, straight couples had been having sex without condoms for roughly 3 years (IQR 0.7 to 11 years) compared to 1.5 years (IQR 0.5 to 4 years) for gay couples. Approximately 23% of couples were in new/recent relationships (<6 months). Self-reported adherence to ART was similarly high at >90% in the three positive groups. Similar proportions of each group also had CD4 counts >350 cells/mm3 (85% to 91%).

 

Based on data from the negative partners, overall, couples reported having sex without condoms a median of 37 times a year (IQR 15 to 71), with gay couples (median 41; IQR 17 to 75) reporting condomless sex at least 22,000 times and heterosexual couples (median 35; IQR 13 to 70) more than 36,000 times. These were rough estimates from recall and partners did not always report the same numbers. Some couples reported sex outside the main relationship: 108 gay couples (33%) and 34 heterosexual couples (4%).

None of the 11 incident HIV infections in negative partners (ten gay and one heterosexual) were phylogenetically linked to the positive partner. Most people (8/11) reported having sex without condoms with people outside the main relationship. All samples (n=22) were successfully sequenced for pol and 91% (n=20) were sequenced for env. None of the partner sequences clustered together and the results were consistent after using using several different analyses. Additional details for these analyses are described in the online supplementary material. [2]

With zero transmissions, the upper limit of the 95% confidence interval (95%CI) for the overall study was 0.3 per 100 couple years of follow up (CYFU). Each category of specific risks, given that the calculations are a factor determined by study numbers and power, had different upper 95%CI boundaries: for example, 0.88 for HT sex overall vs 0.84 for gay sex overall.

This means that the upper 95%CI for receptive anal sex forgay men (2.70 with ejaculation and 1.68 without ejaculation) needs to be interpreted as a factor of sample size: there were fewer CYFU so the upper limit is by definition higher. While this calculation is developed to define the potential range within which the true risk might lie, the 95%CI should not be interpreted as indicating a risk that has been observed in the study. To illustrate this difficulty, the higher estimated risk for heterosexual anal sex with upper 95%CI of 12.71 and 8.14 (with and without ejaculation, respectively) are driven by fewer CYFU with this as the primary risk rather than any biological reason for this to be much higher. Of note though, more than 20% of straight couples reported anal sex.Image result for zero viral load

The ongoing PARTNER 2 study continues to follow up gay couples in the PARTNER study and to recruit additional gay couples, in order to produce a similarly powered evidence base for gay mean as for straight couples, with follow up until 2019. [2]

Also of note during the study, 91 HIV positive partners reported other STIs (n=16 HT men, 16 HT women and 59 gay men) — closely matching STIs in the negative partners, also without any increased risk reported for HIV transmission.

An non-technical i-Base Q&A on these results is also online.

http://www.thebodypro.com/content/77903/zero-no-linked-hiv-transmissions-in-partner-study-.html?ic=sanext

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