The incidence of HIV infection was "extremely low" in a pre-exposure prophylaxis project (PrEP) demonstration in community-based clinics in Miami, San Francisco and Washington, DC; and there were no new infections seen among gay men and bisexual men who have sex with men who took Truvada (tenofovir / emtricitabine) at least twice a week, according to a report inJanuary 26 edition of JAMA Internal Medicine.
Membership of the PrEP was higher among people with higher risk for HIV.
After using Truvada PrEP showed high efficacy daily for men who have sex with men and transgender women in the study internationaliPrExlAlfred Liu, beginning in the Department of Public Health San Francisco and colleagues, who conceived the PrEP demonstration project to explore its effectiveness in clinical practice in the real world. The results werepreviously announcedin part at the International AIDS Society Conference on HIV Pathogenesis of 2015 in Vancouver, Treatment and Prevention in July.
The PrEP demonstration project was carried out between October and February 2012 2015 3 in places: the Miami-Dade Downtown STD Clinic, San Francisco City Clinic, and Whitman Walker Health in Washington, DC. Together the sites registered coalesced 557 participants at risk for HIV infection. Just over half came looking for PrEP clinics while others were referred by providers. Before preparing the seroconversion rate in HIV among gay men in these annual clinics was exceeded in 2%.
Most participants (550) were gay or bisexual men and transgender women were 7. The average age of 35 years, with a fifth of the group in the age group below 25. Almost half (48%) were white, 35% were Latino, 7% were black and 10% were mestizos (...) or other race / ethnicity. About three-quarters reported using recreational drugs. Risk factors included unprotected anal sex with two or more partners, anal sex with HIV-positive partners (including about a quarter with a positive primary partner), or carrying sexually transmitted infections (STIs). About a quarter had gonorrhea, syphilis or chlamydia in the initial screening. The participants had normal renal function at baseline, since it can tenofovir cause renal impairment.
All participants received daily free Truvada pills on an open source basis (non-randomized) to 48 weeks. They had follow-up visits in 1, 3, 6, 9, and twelve months for serology testing for HIV and STI testing, clinical monitoring, counseling, and fractionation of PrEP.
- 3 people were diagnosed as seropositive for HIV at the time of registration.
- 2 participants were infected with HIV during follow-up, with an incidence rate of 0,43 100 by person-years; both had drug levels in the blood, suggesting PrEP took less than two times per week.
- 79% of those enrolled were still keeping the PrEP at the end of the twelve-month period of study.
- About 15% of participants discontinued PrEP - temporarily in many cases - especially due to side effects (e.g., nausea, headache) or to realize in low risk.
- Grip as determined by tenofovir drug level in dried blood spots was about 85% overall, based on previous studies indicating that 4 doses per week They offer good protection levels.
- While the membership reached 90% in San Francisco and 88% in Washington, DC, it was only 65% in Miami.
- Participants reached grip 91% of white people, compared with 77% for Latinos and 57% for black participants.
- People homeless or in unstable housing have provided poor grip levels. But age, education, drugs and alcohol or did not.
- Participants who reported unprotected anal sex with more partners had a better grip (89% or more partners if 2 75% vs up 0-1 3 partners over the past months).
- The average number of anal sex partners decreased during follow-up of the 10,9 9,3.
- The proportion of people who had kept receptive anal sex remained stable at around 66%, but participants were less aimed at sexcom condoms with their length of time at increased PrEP.
- The presence of STIs had great overall incidence (90 100 by person-years) but did not increase over time; Liu reported earlier that the number of participants with STDs decreased during the first 6 months PrEP but rose again to the baseline level.
- The safety and tolerability of PrEP was generally good, with no serious adverse events related to the presence of Truvada.
- Less than 5% of participants experienced mild or moderate elevations of creatinine (a potential of renal function impairment signal), but these problems were resolved without stopping Truvada.
"The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a major US PrEP demonstration project," the study authors concluded. "Adherence was higher among participants who reported higher risk behaviors. Interventions that racial and geographic disparities and instability of the housing may increase the negative impact of PrEP. "
Translated by Claudio Souza's original in English In New HIV Infections Among Consistent Truvada PrEP Users in Demo Project in 21 / 1 / 16 (the link opens in another tab of your browser
AY Liu, SE Cohen, and Vittinghoff, et al. Prophylaxis for HIV infection integrated preexposure with the Municipality and the participants sexual health services. The JAMA Internal Medicine176 (1): 75-84. January 2016.