Gilead reports results from Phase 3 studies of switching to Descovy-based regimens from Truvada-based regimens

25th October 2016 (Last Updated October 25th, 2016 18:30)

Gilead Sciences has reported 96-week data from a Phase 3 study and 48-week data from two Phase 3b studies analysing the safety and efficacy of switching virologically suppressed HIV-1 infected patients from regimens containing Truvada to regimens containing Descovy.

Gilead Sciences has reported 96-week data from a Phase 3 study and 48-week data from two Phase 3b studies analysing the safety and efficacy of switching virologically suppressed HIV-1 infected patients from regimens containing Truvada to regimens containing Descovy.

Results showed regimens containing Descovy (emtricitabine and tenofovir alafenamide 200mg / 25mg; FTC / TAF) to be statistically non-inferior to regimens containing Truvada (emtricitabine and tenofovir disoproxil fumarate 200mg / 300mg; FTC / TDF), with improvements in certain renal and bone laboratory parameters among patients receiving Descovy (FTC / TAF)-based regimens.

Descovy is indicated for use in combination with other anti-retroviral agents for the treatment of HIV-1 infection in patients aged 12 and above.

It should not be used as pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV-1 infection.

"This data also demonstrates 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."

Descovy also comes with a warning in its product label regarding the risks of lactic acidosis / severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.  

In study 1089, 663 virologically suppressed, HIV-infected adults were randomised to switch to regimens containing Descovy or continue on regimens containing Truvada, while remaining on the same third agents.

At week 96, virologic suppression (HIV-1 RNA less than 50 cubic millilitres or c/mL) was maintained in 89% of participants in both groups.

Drug-related serious adverse events were rare and drug discontinuation due to adverse events was low for both treatment groups.

The most commonly reported adverse events included upper respiratory tract infection, diarrhea and nasopharyngitis.

In the same study, the impact of the two regimens on laboratory parameters of kidney and bone health was probed.

Statistically significant differences were observed in mean changes from baseline to week 96 in bone mineral density (BMD) between patients receiving Descovy (FTC / TAF)-based regimens compared to patients receiving Truvada (FTC / TDF)-based regimens.

Furthermore, more patients receiving Descovy (FTC / TAF)-based regimens experienced a greater than 3% improvement in BMD from baseline to week 96, compared with those receiving Truvada (FTC / TDF)-based regimens.

In study 1216, 630 virologically suppressed, HIV-infected adults were randomised to switch to Odefsey or to continue on Complera (rilpivirine 25mg / emtricitabine 200mg / tenofovir disoproxil fumarate 300mg tablets; RPV / FTC / TDF).

At week 48, similar rates of virologic suppression (HIV-1 RNA less than 50c/mL) were maintained in both treatment groups.

Drug-related serious adverse events and drug discontinuation due to adverse events were low across both treatment groups, with a result of 0.1% in both.

The most commonly reported adverse events included upper respiratory tract infection, diarrhea and nasopharyngitis.

Statistically significant improvements favouring Odefsey were observed from baseline to week 48 in mean BMD at the hip and spine compared to patients in the Complera group.

In study 1160, 875 virologically suppressed, HIV-infected adults were randomised to switch to Odefsey, or to continue on Atripla (efavirenz 600mg / emtricitabine 200mg / tenofovir disoproxil fumarate 300mg tablets; EFV / FTC / TDF).

At week 48, high rates of virologic suppression (HIV-1 RNA less than 50c/mL) were maintained in both treatment groups and general safety was similar between the arms.

The most commonly reported adverse events included upper respiratory tract infection, nasopharyngitis and cough.

Statistically significant improvements favouring Odefsey were observed from baseline to week 48 in mean BMD at the hip and spine compared to patients in the Atripla group.

A larger percentage of patients receiving Odefsey showed improvements in their osteopenia or osteoporosis at either the hip or spine.

Gilead executive vice president for research and development and chief scientific officer Norbert W. Bischofberger said: “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.

“This data also demonstrates 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."