Title

ART: Trials and tribulations

Code

MOAB01

Session Type

Oral Abstract SessionTrack B – Clinical Science

Venue

Sala A

Date Time

Monday 22 July, 11:00 - 12:30

Co-Chairs:

Christine Katlama, Hôpital Pitié Salpétière / Sorbonne Universités Paris, France
Graeme Moyle, Chelsea and Westminster Hospital, United Kingdom

11:00 MOAB0101	Virologic efficacy of raltegravir vs. efavirenz-based antiretroviral treatment in HIV1-infected adults with tuberculosis: W48 results of the ANRS 12300 Reflate TB2 trial Nathalie De Castro, APHP- Hopital Saint Louis, France	Abstract Slides

11:15 MOAB0102	Week 96 safety and efficacy of the novel HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced participants infected with multi-drug resistant HIV-1 (BRIGHTE study) Max Lataillade, ViiV Healthcare, United States	Abstract Slides

11:30 MOAB0103	Patient views on long acting HIV treatment: Cabotegravir + rilpivirine as maintenance therapy (ATLAS 48 week results) Miranda Murray, ViiV Healthcare, United Kingdom	Abstract Slides

11:45 MOAB0104	Virologic failure In ART-naive HIV patients with high pre-therapy viral load burden initiating on common core agents Anthony M Mills, Men’s Health Foundation, United States	Abstract Slides

11:55 MOAB0105	Switching to a single-tablet regimen bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) from dolutegravir (DTG) plus emtricitabine and either tenofovir alafenamide or tenofovir disoproxil fumarate (F/TAF or F/TDF) Paul E. Sax, Brigham and Women's Hospital, Harvard Medical School, United States	Abstract Slides

12:10 MOAB0106	Longer-term (96-week) efficacy and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in women Cissy Kityo, Joint Clinical Research Centre, Uganda	Abstract Slides

AUTHOR

Laura Waters

SUMMARY

This session included abstracts on raltegravir vs efavirenz in people with TB (Reflate TB2), W96 fostemsavir results (BRIGHTE), patient reported outcomes on injectable ART (ATLAS), first-line outcomes at high viral load (OPERA cohort), 48W results for dolutegravir to bictegravir switch (380-4030) & 'long-term' safety of switch to bictegravir/F/TAF in women.

HIGHLIGHTS

Raltegravir 400mg BID wasn’t non-inferior to efavirenz in people on standard TB treatment at W48; efavirenz remains 1st line in TB. Fostemsavir yielded remarkable W96 suppression in people with significant resistance & advanced HIV: 60% of randomised cohort, 37% of non-randomised cohort (no other predicted active agents). In ATLAS, greater patient reported outcomes improvements for people receiving injectables; 97% preferred IM ART to oral; questions highlighted channeling bias. Amongst 2,038 people in OPERA starting ART with baseline VL >100,000 dolutegravir outperformed elvitegravir, darunavir & raltegravir at W36. Study 380-4030 demonstrated non-inferior viral suppression maintenance switching from dolutegravir (primarly with F/TAF) to bictegravir/F/TAF with no impact of (limited) baseline NRTI resistance (14% with genotypic NRTI resistance; additional 10% by proviral DNA). Finally switching virally suppressed women to bictegravir/F/TAF yielded excellent virological & safety outcomes, including expected renal marker improvement switching from tenofovir-DF, at week 48/96 in deferred/immediate switch arms.

CRITICAL ASSESSMENT

Reflate reminds us phase 2 results may not portend phase 3 & W24 endpoints can change by W48 – treat early analyses with caution! Fostemsavir ‘almost’ here (US filing this year), an important addition for those with limited options. ART at high viral loads yields lower viral suppression; dolutegravir may be better option than, particularly, darunavir, but confounder adjustment needed. Not sure 380-4030 says much beyond people who are suppressed stay suppressed if switched to very similar drugs & “bictegravir/F/TAF OK if suppressed with M184V” (Paul Sax). Finally, bictegravir/F/TAF an efficacious switch option for women, though little known about pregnancy.