GS - US- 311-1089   Switching Tenofovir DF to Tenofovir Alafenamide in virally suppressed patients

48 week data was presented; RCT, double blinded  evaluated safety and efficacy of switching from F/TDF to F/TAF  vs continuing F/TDF while remaining on the third agent. 50% of third agent was a boosted PI.  663 patients were randomised to the two arms. Patients vl were < 50 copies and stable. eGFR was > or= to 50

Very little failure described. The nature of the third agent made no difference to outcomes. Very foew AE's leading to discontinuation occurred.

eGFR improved and proteinuria decreased when switched to F/TAF.    BMD did not worsen in the F/TDF group. BMD improved in the F/TAF group at both 24 and 48 weeks. Lipids increased in the F/TAF group.  F/TAF was shown to be not inferior in terms of virological suppression.

 

Latte 2  week 32 results - Cabotegravir + Rilpilvirine as long acting maintainence therapy,  INSTI and NNRTI long acting injectable nano-suspension. 

Phase 2b open label study ART na├»ve. 20 week induction daily oral CAB + ABC/3TC randomised to one of three arms - IM CAB LA + IM RPV LA every 4 weeks ; or the same every 8 weeks ; or to remain on the oral CAB + ABC/3TC

309 subjects enrolled.  median age 35.  8% female.  15% African American  Median CD4 ^400  19% viral load > 100,000.

32 week data. 286 subjects randomised to maintainence therapy. most common AE was injection site pain with 99 of these reported as mild. These lasted a median of 3 days with all resolved by 7 days. 1% eventually withdrew citing injection site reaction. most non ISR AE's were fever, fatigue , and flulike symptoms. There was one death unrelated to study due to epileptic eizure.  > 95% cited high level of satisfaction with the injectable therapy.

All arms demonstrated comparable antiviral activity. At this time no regimen has been ruled out.