– 96-Week Data Found Genvoya to be Non-Inferior with Improved
Renal and Bone Parameters Compared to Stribild® –
Gilead Sciences, Inc. (NASDAQ:GILD) today announced 96-week results from
two Phase 3 studies (Studies 104 and 111) 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-naïve adults. Genvoya was found to be
statistically non-inferior to 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. Patients receiving Genvoya also
had improved renal and bone laboratory parameters compared to those
treated with Stribild. The data were presented at the 15th
European AIDS Conference (EACS) in Barcelona (session: BD 01).
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,
Madrid, Spain. “The data presented this week show Genvoya has the
potential to help preserve the health of a range of appropriate HIV
patients.”
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 Europe, we look forward to bringing Genvoya and our
other next-generation TAF-based therapies to patients as quickly as
possible.”
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).
On September 24, 2015, the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) adopted a positive
opinion on the company’s Marketing Authorization Application for
Genvoya. The CHMP’s recommendation will now be reviewed by the European
Commission, which has the authority to approve medicines for use in the
28 countries of the European Union. Based on initial data from Studies
104 and 111, announced in September 2014, Gilead filed a New Drug
Application for Genvoya with the U.S. Food and Drug Administration (FDA)
on November 5, 2014. Under the Prescription Drug User Fee Act, the
agency has set a target action date of November 5, 2015.
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
region (United States or ex-United States) at screening. After 48 weeks,
high rates of viral suppression were observed in both study arms
(Genvoya 92 percent and Stribild 90 percent) and Genvoya met the primary
objective of non-inferior efficacy compared to Stribild, defined as the
proportion of participants who had HIV-1 RNA < 50 copies/mL using the
FDA Snapshot Algorithm.
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.
About Gilead
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City, California.
Forward-Looking Statement
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, FDA or other regulatory
authorities, and any marketing approvals, if granted, may have
significant limitations on their use. In addition, data from additional
TAF studies may be unfavorable. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is cautioned
not to rely on these forward-looking statements. These and other risks
are described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended June 30, 2015, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
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 Gilead
Sciences, Inc., or its related companies.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000
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