Gilead announced positive results from Phase 3 studies which switched virologically suppressed HIV-1 patients from regimens containing Truvada (emtricitabine and tenofovir disoproxil fumarate 200mg/300mg; FTC/TDF) to regimens containing Descovy (emtricitabine and tenofovir alafenamide 200mg/25mg; FTC/TAF).
Descovy is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 12 years of age and older.
A total of 663 virologically suppressed HIV infected adults took part in ‘Study 1089′, in which they were randomized to switch to Descovy or stay on a Truvada regimen, while continuing the same third agents. At week 96, virologic suppression (HIV-1 RNA <50 c/mL) was maintained in 89% of patients in both groups (difference in %: –0.5%; 95% CI: –5.3% to 4.4%).
As well as being found non-inferior to Truvada, regimens containing Descovy demonstrated improvements in certain renal and bone parameters.The same study demonstrated statistically significant changes in baseline to week 96 in bone mineral density (BMD) in Descovy versus the Truvada-treated arm; spine: 2.15% vs. –0.17%; hip: 1.85% vs. –0.33%; p<0.05 for both. Glomerular filtration rate also improved in the Descovy group; eGFR; +10.00mL/min vs. +4.00mL/min; P<0.05. Other renal parameters favoring Descovy were urine protein-to-creatinine ratio (–26.0% vs. +2.7%; p<0.05); urine albumin-to-creatinine ratio (+3.4% vs. +27.0%; P<0.05); urine retinol binding protein-to-creatinine ratio; (–4.1% vs. +42.6%; P<0.05); and urine beta-2 microglobulin-to-creatinine ratio (–29.7% vs. +46.8%; P<0.05).
“As people are living longer with HIV, several studies show that patients who switch from regimens containing Truvada to regimens containing Descovy are able to maintain viral suppression while improving renal and bone laboratory markers, which may help address long-term health needs,” said Dr. Chloe Orkin, Consultant, Barts Health NHS Trust, London.
The results were shared at an oral session ‘Treatment Strategies’, at the 2016 HIV Glasgow conference in Scotland.
For more information visit HIVGlasgow.org.