October 22, 2015
Gilead Announces Phase 3 Results for Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV
– 96-Week Data Found Genvoya to be Non-Inferior with Improved Renal and Bone Parameters Compared to Stribild® –
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,” said José R.
Arribas, Associated Professor of Medicine, Hospital La Paz, IdiPAZ,
In the combined analysis of Studies 104 and 111, a total of 1,733 treatment-naïve adults with HIV were randomized to receive either Genvoya or Stribild. At 96 weeks, 86.6 percent (n=750/866) of patients taking Genvoya and 85.2 percent (n=739/867; CI -1.8 percent to +4.8 percent, p=0.36) 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 adverse events were low in both treatment arms (1.2 percent (n=10) for Genvoya vs. 2.3 percent (n=20) for Stribild). The most common side effects were headache, diarrhea and nausea.
The combined analysis investigated the effect of the two regimens on kidney, bone and lipid laboratory parameters over the 96-week period. To examine kidney function, multiple laboratory tests of renal and tubular function were conducted, all of which statistically favored Genvoya. This included a statistically significant difference in the median change in estimated glomerular filtration rate (eGFR) from baseline to week 96, favoring Genvoya (-2.0 mL/min for Genvoya vs. -7.5 mL/min for Stribild, p<0.001). Patients taking Genvoya had smaller declines in bone mineral density (BMD) compared to patients taking Stribild, as assessed by DXA (spine: -0.96 vs. -2.79, p<0.001; hip: -0.67 vs. -3.28, p<0.001). Patients on Genvoya had statistically higher increases in total, LDL and HDL cholesterol from baseline than patients on Stribild, while there was no significant difference between the arms in the total cholesterol to HDL ratio. Finally, there were no reports of proximal renal tubulopathy (including Fanconi Syndrome) in the Genvoya arm while there were two cases in the Stribild arm.
“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,” said Norbert W.
Bischofberger, PhD, Gilead’s Executive Vice President, Research and
Development and Chief Scientific Officer. “Pending regulatory approvals
in the U.S. and
Additional investigational Phase 3 study results for Genvoya that will be presented at EACS include a 48-week analysis of Study 109 in adult patients switching from boosted atazanavir (ATV) plus F/TDF to Genvoya (session: PS10), sub-analyses of Studies 104 and 111 examining Genvoya vs. Stribild among treatment-naïve adult women at 48 weeks (poster: PE7/13) and drug resistance through 48 weeks in treatment-naive subjects receiving Genvoya (poster: PE9/5).
Genvoya is an investigational product and has not been determined to be safe or efficacious.
About Studies 104 and 111
Studies 104 and 111, originally planned for 96 weeks but recently
extended to 144 weeks, are randomized, double-blind, controlled Phase 3
trials conducted among 1,733 treatment-naïve adults living with HIV. At
study enrollment, 15 percent of subjects were women, 25 percent
identified themselves as Black or of African descent and 23 percent had
viral loads ≥100,000 copies/mL. Patients were randomized 1:1 to receive
an STR of Genvoya or Stribild; randomization included stratification for
CD4 count (< 50 cells/µL, 50 to 199 cells/µL, or ≥ 200 cells/µL) and
The studies are ongoing in a blinded fashion. After week 144, patients will continue to take their blinded study drug until treatment assignments have been unblinded, at which point all will be given the option to participate in an open-label rollover extension and receive Genvoya until it is approved for use in the relevant country. Additional information about the studies can be found at www.clinicaltrials.gov.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that the marketing authorizations for Genvoya and other TAF-based
regiments may not be approved by the EMA,
The European SmPCs for Stribild and Viread are available from the EMA website at www.ema.europa.eu.
Genvoya, Stribild and Viread are registered trademarks of
For more information on
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Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936
Ryan McKeel, +1 650-377-3548
Kristine Kelly, +44 (0) 7810 868 956