– Through Three Years of Treatment, Genvoya
Demonstrates Significantly Higher Rates of Virologic Suppression
and Favorable Renal and Bone Laboratory Parameters Compared to
Stribild® –
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 and headache.
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 lipid-modifying agents.
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.
Contraindications
- 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 safety.
Adverse reactions
- Common adverse reactions
(incidence ≥5%; all grades) in clinical studies were nausea (10%),
diarrhea (7%), headache (6%), and fatigue (5%).
Drug interactions
- Prescribing information: Consult
the full prescribing information for Genvoya for more information
on Contraindications, Warnings, and potentially significant drug
interactions, including clinical comments.
- 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 mL/min.
- Hepatic impairment: Not
recommended in patients with severe hepatic impairment.
- Testing prior to initiation:
Test patients for HBV infection.
- 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.
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 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 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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version on businesswire.com: http://www.businesswire.com/news/home/20170214006531/en/
Gilead Sciences, Inc.Sung Lee, 650-524-7792InvestorsRyan McKeel,
650-377-3548Media
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