David Orth

Clinical posts from members and guests of the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) from various international medical and scientific conferences on HIV, AIDS, viral hepatitis, and sexual health.

Key Antiviral Therapy RCT's Cabotegravir LA injection and TAF(again)

Posted by on in New ARV Treatment, clinical trials emerging therapy
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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.

 

 

 

 

Tagged in: CROI2016
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