Switching HIV Regimens to Include Odefsey Shows Positive Results

Gilead recently announced positive results from two 48-week long clinical trials involving virologically suppressed HIV-positive patients switching their treatment regimens to those involving Odefsey.

Odefsey (rilpivirine 25-mg/emtricitabine 200-mg/tenofovir alafenamide 25-mg tablets; RPV/FTC/TAF) is a treatment for HIV-positive patients who have not received previous antiretroviral treatment. It can also replace an antiretroviral regimen in virologically suppressed patients who have not experienced treatment failure, and do not have any resistance to the components of the drug.

It also has a boxed warning regarding the increased risk of lactic acidosis/severe hepatomegaly with steatosis, and exacerbation of hepatitis B virus.

In Study 1216, 630 virologically suppressed HIV-positive adults were randomized to either stay on or switch their regimen from Complera (rilpivirine 25-mg/emtricitabine 200-mg/tenofovir disoproxil fumarate 300-mg tablets; RPV/FTC/TDF) to Odefsey.

Investigators found that both treatment groups maintained 94% virologic suppression among patients at week 48. They also discovered significant improvements in bone mass density in the Odefesy group (spine: +1.61 percent vs. +0.08 percent; hip: +1.04 percent vs. -0.25 percent; p<0.001 for both).

Improvements were also seen in renal parameters, including changes in estimated glomerular filtration rate, urine protein-to-creatinine ratio, urine albumin-to-creatinine ratio, and urine beta-2 microglobulin-to-creatinine ratio.

Common adverse events included upper respiratory tract infection, diarrhea, and nasopharyngitis. Only 0.1% of patients in both treatment groups stopped treatment due to adverse events.

There were no cases of Fanconi syndrome or proximal renal tubulopathy reported, according to Gilead.

In the second study, Study 1160, 875 patients were randomized to switch their treatment to a regimen containing Odefsey, or continue taking Atripla (efavirenz 600-mg/emtricitabine 200-mg/tenofovir disoproxil fumarate 300-mg tablets; EFV/FTC/TDF).

Patients in both treatment groups has high rates of virologic suppression, but patients taking Atripla had higher rates compared to those taking Odefsey (92% versus 90%).

Improvements were seen in patients taking Odefsey at week 48. Patients taking Odefsey had increased improvements in bone mass density compared with patients taking Atripla (spine: +1.65 percent vs. +0.05 percent; hip: +1.28 percent vs. -0.13 percent; p<0.001 for both).

Patients taking Odefsey also showed improvements in osteopenia or osteoporosis at the hip or spine, according to Gilead.

Similar rates of safety were noted between both groups, and adverse events included matched its known profile.

“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,” said Norbert W. Bischofberger, PhD, Gilead’s executive vice president, Research and Development and chief scientific officer.