– Through Three Years of Treatment, Genvoya Demonstrates
Significantly Higher Rates of Virologic Suppression and Favorable Renal
and Bone Laboratory Parameters Compared to Stribild®
SEATTLE--(BUSINESS WIRE)--Feb. 14, 2017--
Gilead Sciences, Inc. (NASDAQ: GILD) today announced 144-week data from
two Phase 3 studies (Studies 104 and 111) evaluating the safety and
efficacy of Genvoya® (elvitegravir 150 mg, cobicistat
150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg) for the
treatment of HIV-1 infection in treatment-naïve adults. Through Week
144, Genvoya demonstrated significantly higher rates of virologic
suppression compared to Gilead’s Stribild® (elvitegravir 150
mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil
fumarate 300 mg), based on the percentage of patients with HIV-1 RNA
levels less than 50 copies/mL. Patients receiving Genvoya also
demonstrated favorable renal and bone laboratory parameters compared to
those treated with Stribild. The data were presented in a poster session
(Poster 0393) at the 2017 Conference on Retroviruses and Opportunistic
Infections (CROI) in Seattle.
Genvoya is indicated as a complete regimen for the treatment of HIV-1
infection in adults and pediatric patients 12 years of age and older who
have no antiretroviral treatment history or to replace the current
antiretroviral regimen in those who are virologically suppressed (HIV-1
RNA levels less than 50 copies/mL) on a stable antiretroviral regimen
for at least six months with no history of treatment failure and no
known resistance to the components of Genvoya. Genvoya has a boxed
warning in its product label regarding the risks of lactic
acidosis/severe hepatomegaly with steatosis, and post treatment acute
exacerbation of hepatitis B. See below for important safety information.
“As people grow older with HIV, physicians are increasingly looking for
highly effective medications that may help address the evolving needs of
their patients who face a lifetime of antiretroviral therapy,” said Jose
Arribas, MD, Associated Professor of Medicine, Hospital La Paz, IdiPAZ,
Madrid, Spain and the lead study investigator. “These study results
further demonstrate that Genvoya provides durable viral suppression and
has a demonstrated safety profile for long-term use by 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 Week 144, 84.2 percent (n=729/866) of patients
taking Genvoya and 80 percent (n=694/867; 95 percent CI: 0.6 percent to
7.8 percent, p=.021) of patients taking Stribild achieved HIV-1 RNA
levels less than 50 copies/mL. Additionally, at Week 144, 81.1 percent
(n=702/866) of patients taking Genvoya and 75.8 percent (n=657/867; 95
percent CI: 1.5 to 9.2 percent, p=.006) of patients taking Stribild
achieved HIV-1 RNA levels less than 20 copies/mL, a secondary endpoint.
At Week 144, virologic failure was similar between groups (Genvoya, 4.6
percent; Stribild, 3.9 percent); the difference in overall results was
driven by fewer discontinuations on Genvoya due to adverse events or
other reasons not related to efficacy (Genvoya, 11.2 percent; Stribild,
16.0 percent). There were statistically significant fewer adverse events
leading to discontinuation in the Genvoya arm compared to the Stribild
arm (Genvoya, 1.3 percent; Stribild, 3.3 percent, p=0.01). The most
common drug-related adverse events in both groups were nausea, diarrhea
A separate analysis investigated the effect of the two regimens on
laboratory parameters of kidney, bone and plasma lipid levels. To
examine kidney function, specific protein markers of glomerular and
tubular function were examined, all of which favored Genvoya. This
included a statistically significant difference in the median change in
estimated glomerular filtration rate (eGFR) from baseline to Week 144
(Genvoya, -1.6 mL/min; Stribild, -7.7 mL/min, p<0.001). There were no
cases of renal tubulopathy in the Genvoya arm and four cases in the
Stribild arm. No participants on Genvoya had renal-related
discontinuations compared to 12 participants in the Stribild arm
(p˂0.001). The analysis also found that decreases in bone mineral
density (BMD) were significantly less in the Genvoya group versus the
Stribild group for both lumbar spine and total hip (spine: Genvoya,
-0.92 percent; Stribild, -2.95 percent, p<0.001; hip: Genvoya, -0.75
percent; Stribild, -3.36 percent, p<0.001). The long-term clinical
significance of changes in eGFR and BMD is not known. Finally, patients
on Genvoya had statistically higher increases in total, LDL and HDL
cholesterol from baseline to Week 144 compared to patients on Stribild.
There was no significant difference in the total cholesterol-to-HDL
ratio at Week 144, nor any difference in the rate of initiation of
About Studies 104 and 111
Studies 104 and 111, originally planned for 96 weeks and extended to 144
weeks, were randomized, double-blind, controlled Phase 3 trials
conducted among 1,733 treatment-naïve adults living with HIV. The
primary endpoint of the study was at Week 48, in which Genvoya was
non-inferior to Stribild. Genvoya was also non-inferior at the secondary
endpoint of efficacy at Week 96. 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 a single tablet regimen 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.
Additional information about the studies can be found at www.clinicaltrials.gov.
Important U.S. Safety Information for Genvoya
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and
POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside analogs in
combination with other antiretrovirals.
Genvoya is not approved for the treatment of chronic hepatitis B
virus (HBV) infection and the safety and efficacy of Genvoya have not
been established in patients coinfected with HIV-1 and HBV. Severe
acute exacerbations of hepatitis B have been reported in patients who
are coinfected with HIV-1 and HBV and have discontinued products
containing emtricitabine and/or tenofovir disoproxil fumarate (TDF),
and may occur with discontinuation of Genvoya. Hepatic function should
be monitored closely with both clinical and laboratory follow-up for
at least several months in patients who are coinfected with HIV-1 and
HBV and discontinue Genvoya. If appropriate, initiation of
anti-hepatitis B therapy may be warranted.
Coadministration: Do not use with drugs highly dependent on
CYP3A for clearance and for which elevated plasma concentrations are
associated with serious and/or life-threatening events. Do not use
with drugs that strongly induce CYP3A as this may lead to loss of
efficacy and possible resistance to Genvoya. Do not use with
alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin,
lurasidone, pimozide, dihydroergotamine, ergotamine, methylergonovine,
cisapride, lovastatin, simvastatin, sildenafil for pulmonary arterial
hypertension, triazolam, oral midazolam, or St. John’s wort.
Warnings and precautions
Drug interactions: See Contraindications and Drug Interactions
sections. Consider the potential for drug interactions prior to and
during Genvoya therapy and monitor for adverse reactions.
Fat redistribution or accumulation has been observed in
patients receiving antiretroviral therapy.
Immune reconstitution syndrome, including the occurrence of
autoimmune disorders with variable time to onset, has been reported.
New onset or worsening renal impairment: Cases of acute renal
failure and Fanconi syndrome have been reported with the use of
tenofovir prodrugs. In clinical trials of Genvoya, there have been no
cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not
initiate Genvoya in patients with estimated creatinine clearance
(CrCl) <30 mL/min. Patients with impaired renal function and/or taking
nephrotoxic agents (including NSAIDs) are at increased risk of
renal-related adverse reactions. Discontinue Genvoya in patients who
develop clinically significant decreases in renal function or evidence
of Fanconi syndrome.
Renal monitoring: In all patients, monitor serum creatinine,
serum phosphorus, CrCl, urine glucose, and urine protein prior to
initiating and during therapy as clinically appropriate. If serum
creatinine increases >0.4 mg/dL from baseline, closely monitor for renal
Common adverse reactions (incidence ≥5%; all grades) in
clinical studies were nausea (10%), diarrhea (7%), headache (6%), and
Prescribing information: Consult the full prescribing
information for Genvoya for more information on Contraindications,
Warnings, and potentially significant drug interactions, including
Metabolism: Genvoya can increase the concentration of drugs
metabolized by CYP3A, CYP2D6, P-gp, BCRP, OATP1B1, or OATP1B3. Drugs
that inhibit CYP3A, P-gp, or BCRP can increase the concentrations of
components of Genvoya. Drugs that induce CYP3A or P-gp can decrease
the concentrations of components of Genvoya.
Drugs affecting renal function: Coadministration of Genvoya
with drugs that reduce renal function or compete for active tubular
secretion may increase concentrations of emtricitabine and tenofovir
and the risk of adverse reactions.
Dosage and administration
Dosage: Patients 12 years and older (≥35 kg): 1 tablet taken
orally once daily with food.
Renal impairment: Not recommended in patients with CrCl <30
Hepatic impairment: Not recommended in patients with severe
Testing prior to initiation: Test patients for HBV
Testing prior to initiation and during treatment: Assess
serum creatinine, serum phosphorus, CrCl, urine glucose and urine
protein as clinically appropriate.
Pregnancy and Lactation
Pregnancy: There are insufficient data on the use of Genvoya
during pregnancy. In animal studies, no adverse developmental effects
were observed with the components of Genvoya. An Antiretroviral
Pregnancy Registry has been established.
Lactation: Women infected with HIV-1 should be instructed not
to breastfeed, due to the potential for HIV-1 transmission.
About Gilead Sciences
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.
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 physicians may not see the benefits of prescribing Genvoya for the
treatment of HIV. 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
September 30, 2016, 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.
U.S. full prescribing information for Genvoya and Stribild, including BOXED
WARNINGS, is available at www.gilead.com.
GENVOYA and STRIBILD are trademarks of Gilead Sciences, Inc., or its
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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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792