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 naïve. 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.