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ASHM Report Back
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.
Is QUAD the new black?
Session 26 on Wednesday was " State of ART and drug resistance” did not launch any new blockbuster antiretroviral – unlike some previous World AIDS or CROIs. However there was the first phase 3 results presented for QUAD.
Paper 101 is a 48 week phase 3 data on QUAD – Elvitegravir/Cobicistat/Emtricitabine/Tenofovir (trying saying that after 3 Seattle micro-brewery Pale Ales) versus Atripla involving 700 treatment naive patients. Quad was non-inferior to EFV/FTC/TDF with 88% and 84%, respectively, having viral suppression at week 48. Virologic failure rates at week 48 were 7% in both arms. Of AE occurring in ≥10% of subjects nausea was significantly more frequent in Quad than EFV/FTC/TDF, while dizziness, abnormal dreams, insomnia and rash were significantly less common in Quad than EFV/FTC/TDF. Of note creatinine clearance decrease was significantly greater than with EFV/FTC/TDF (–14.3 vs –3.0 mL/min by week 48).
A parallel phase 3 study is to be presented on Thursday (627) with the comparator arm being booster atavanavir /FTC/TDF in 708 treatment naive patients. Quad was non-inferior to EFV/FTC/TDF with 90% and 87% respectively, having viral suppression at week 48. Virologic failure rates at week 48 were 5% in both arms. Of AE occurring in ≥10% of subjects elevated bilirubin was significantly more frequent in the atavanavir arm. Of note creatinine clearance decrease was significantly greater than with the atavanavir arm (–12.7 vs –9.5 mL/min by week 48).
So in summary QUAD is a highly effective new STR (single tablet regimen) for HIV therapy. A concern is the decline in renal function with QUAD found in both studies which remains to be fully explained.