Increased Benefit in HIV Switching to Descovy from Truvada
Descovy showed non-inferiority to Truvada, and benefited bone and kidney health.
Gilead recently announced results from a 96-week, phase 3 clinical trial that evaluated the safety and efficacy of switching regimens in HIV-positive patients who achieved virologic suppression.
In the study, patients switched from reigmens containing Truvada (emtricitabine and tenofovir disoproxil fumarate 200-mg/300-mg; FTC/TDF) to those containing Descovy (emtricitabine and tenofovir alafenamide 200-mg/25-mg; FTC/TAF).
Overall, investigators found that regimens including Descovy demonstrated non-inferiority to those containing Truvada, according to a press release from Gilead. Patients taking Descovy had improvements in renal and bone laboratory parameters.
“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, MBBCh, MSc, consultant, Barts Health NHS Trust, London. “Along with its favorable safety profile, Descovy offers patients and physicians a versatile treatment backbone that can be paired with a range of third agents.”
Descovy is indicated for use in combination with other antiretroviral agents. The drug is not intended to be used as a pre-exposure prophylaxis to reduce the risk of HIV, and includes a boxed warning for increased risk of lactic acidosis/severe hepatomegaly with steatosis, and exacerbation of hepatitis B virus.
Included in Study 1089 were 663 virologically suppressed HIV-positive adults who were randomized to switch their regimen or continue taking Truvada. Investigators found that virologic suppression was maintained in 89% of all patients regardless of treatment at week 96.
The most common adverse events were upper respiratory tract infection, diarrhea, and nasopharyngitis.
Investigators also studied the effect of the regimens on laboratory parameters on kidney and bone health. More patients receiving Descovy had a greater than 3% improvement in bone mineral density at week 96 compared with patients receiving Truvada.
Benefits were also seen in kidney parameters, including changes in estimate glomerular filtration rate, urine protein-to-creatinine ration, urine albumin-to-creatinine ration, urine retinol binding protein-to-creatinine ratio, and urine beta-2 microglobulin-to-creatinine ratio, according to Gilead.
No patients developed Fanconi syndrome. There were no cases of proximal renal tubulopathy in patients taking Descovy, and 1 in the Truvada group.
“Results from the studies presented at HIV Glasgow further support the efficacy, as well as the renal and bone safety profile, of regimens containing Descovy as treatment options for appropriate virologically suppressed patients,” said Norbert W. Bischofberger, PhD, Gilead’s executive vice president, Research and Development and Chief Scientific Officer. “These data also demonstrate Gilead’s ongoing commitment to developing treatments that may improve health as people grow older with HIV while we continue to search for a cure for the virus.”