Gilead presents Phase III results for Genvoya in HIV
pharmafile | October 22, 2015 | News story | Medical Communications, Research and Development | Genvoya, Gilead Sciences, HIV
Gilead Sciences has today announced 96-week results from two Phase III studies evaluating its investigational once-daily single tablet regimen (STR), Genvoya (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg or E/C/F/TAF), for the treatment of HIV-1 infection in treatment-naive adults.
Studies 104 and 111 found Genvoya to be statistically non-inferior to Gilead’s existing medications Stribild (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF), based on percentages of patients with HIV-1 RNA levels less than 50 copies/ml- the standard measurement of viral levels in the blood.
Patients receiving Genvoya also had improved renal and bone laboratory parameters compared to those treated with Stribild, according to data presented at the 15th European AIDS Conference (EACS) in Barcelona this week.
TAF is a novel, investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread (TDF), as well as improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents.
“As people live longer with HIV and remain on antiretroviral treatments throughout their lives, there is a need for new regimen options for people with HIV- and treatment-related comorbidities,” says José Arribas, associate professor of medicine, Hospital La Paz, IdiPAZ, Madrid, Spain. “The data presented this week show that Genvoya has the potential to help preserve the health of a range of appropriate HIV patients.”
In the combined analysis of the two studies, 1,733 treatment-naive adults with HIV were randomised to receive either Genvoya or Stribild. At 96 weeks, 86.6 percent of patients taking Genvoya and 85.2 percent of patients taking Stribild achieved HIV-1 RNA levels less than 50 copies/ml.
The analysis found that the rate of virologic success between the two regimens was similar across patient subgroups (age, gender, race, baseline HIV-1 RNA level and baseline CD4 count). Discontinuations due to intolerable side effects were also low in both treatment arms at 1.2% for Genvoya vs. 2.3 percent for Stribild). The most common negative side effects were headache, diahorrea and nausea.
The combined analysis investigated the effect of the two regimens on kidney, bone and lipid laboratory parameters in several tests over the 96-week period- all of which statistically favoured Genvoya.
Norbert W. Bischofberger, Gilead’s executive vice president, Research and Development and CSO, says: “The two-year data presented this week further support the long-term utility of Genvoya, given the sustained viral suppression and continued improvements in renal and bone safety markers. Pending regulatory approvals in the US and Europe, we look forward to bringing Genvoya and our other next-generation TAF-based therapies to patients as quickly as possible.”
Joel Levy
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