5) Over 48 weeks, the frequency of clinical adverse events (1.3 per participant) and frequency of abnormal liver function tests were similar in both groups. Our study indicates that it is not only safe to prescribe ART and NTX concurrently, but to initiate them concurrently.

4) We looked at adverse events in a double-blind randomized clinical trial in Lima, Peru. Participants were recently diagnosed with HIV; they initiated ART and were randomized to receive oral naltrexone or a placebo for 24 weeks, followed by 24 weeks receiving ART alone.

3) Use of alcohol or other drugs can exacerbate the effects of HIV and may lead to decreased adherence to one's ART regimen. Thus, the safety of concurrent use of naltrexone and ART is a pertinent question. Does it result in poor clinical outcomes or abnormal lab values?.

2) We know the following: HIV & alcohol use disorder (AUD) disproportionately affect men who have sex with men (MSM) and transgender women. Naltrexone is safe and efficacious as a medication-assisted therapy for AUD. Antiretroviral therapy (ART) is lifesaving for people with HIV.

Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy.

Sex-on-premise venues, associated risk behaviors, and attitudes toward venue-based HIV testing among men who have sex with men in Lima, Perú:

15/ Can @WHO and @aidsinfo guidelines explicitly mention starting ART during acute infection? . We think they should! And thanks to our participants @DuerrHOPEgroup @impactaperu and all our participants and amazing staff who made this work possible! @HIVMA @fredhutch @UWMedicine.

14/ So what are the conclusions? Well, we started off by stating that all PLWH should get ART right away. But now we have data to say that waiting even a short while after HIV acquisition can have negative effects on the persons symptoms, and also their immune system.

13/ Here are some other pretty violin plots of individual cytokines before and after ART, by treatment group

12/ We also looked at a large panel of soluble immune biomarkers. Same conclusion: People treated within 30 days of EDDI remained distinct from those treated later, even after all groups treated for the same duration

11/ However, when we looked by as-treated groups, the CD4/CD8 ratio definitely improved most in those treated within 30 days of EDDI compared to those waiting >90 days to start ART

10/ We also looked at CD4, CD4/CD8 ratio and HIV viral load: over 48 weeks, there weren’t many differences in the intent-to-treat analysis, except the CD4/CD8 ratio, which improved more in the Immediate arm

9/ We also evaluated outcomes by time from estimated date of detectible infection (EDDI) to ART, since many Deferred people started ART early: as-treated analysis. Same pattern of adverse events: People who started ART <30 days of EDDI were least likely to experience AEs.

8/ What type of events? The risk of any infection was much lower in those on ART immediately (p=0.005) including upper respiratory infections and EVEN AIDS-defining opportunistic infections, like shingles and extra-pulmonary TB.

7/ Deferred participants were more likely (IRR 0.67, p=0.02) to experience non-ART adverse events overall, and when limited to time receiving ART (to reduce bias in attribution), this was more pronounced (IRR 0.62, p=0.003).

6/ People in the Deferred Arm were also more likely to experience adverse events, even though they only waited 6 months. In fact, 23% of Deferred participants ended up starting ART early due to low CD4 count or symptoms of acute retroviral syndrome or infections

5/ 216 people randomized, 105 to Immediate ART, and 111 to Defer. All in the Immediate arm started ART within 6 days. 5 people in Deferred never started at all and another 5 (9%) didn’t start on time. We know now that people not offered ART immediately are less likely to start

Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study

4/ How did we randomize people to wait for ART? This occurred from 2013-2016 before INSIGHT-START or TEMPRANO helped change @WHO guidelines. All persons received ART in accordance with Peruvian Ministry of Health guidelines @Minsa_Peru.

3/ So, the @DuerrHOPEGroup and @Impactaperu set out to evaluate this question in the Sabes cohort, which followed MSM and transwomen for incident HIV in Lima, Peru. Persons with newly acquired HIV were randomized to receive ART immediately or wait 6 months