China National Drug Administration Approves Gilead’s Genvoya® (Elvitegravir, Cobicistat, Emtricitabine & Tenofovir Alafena...
August 06 2018 - 6:09AM
Business Wire
- Genvoya is the First TAF-Based Regimen
Approved in China for Adults and Adolescents with HIV -
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the
China National Drug Administration (CNDA) has approved Genvoya®
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200
mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of
HIV-1 infection. Genvoya is the first TAF-based single tablet
regimen for the treatment of HIV to be approved in China.
Genvoya is indicated in China as a complete regimen for the
treatment of adults and adolescents (aged 12 years and older
with a body weight of at least 35 kg) infected with HIV-1
without any known mutations associated with resistance to the
integrase inhibitor class, emtricitabine or tenofovir. In the
United States, Genvoya has a boxed warning in its product label
regarding the risks of post treatment acute exacerbation of
hepatitis B. Further important safety information, adverse drug
reactions and drug interactions are listed below.
“With access to appropriate treatment, people living with HIV
have the potential to live nearly as long as the general
population. Because of this, they may face increased risk of age-
and treatment-related comorbidities, which means long-term health
should be a priority when caring for patients with HIV,” said
Professor Li Taisheng, Peking Union Medical College Hospital. “In
clinical trials, Genvoya has demonstrated long-term viral
suppression through 144 weeks and has a safety profile that may be
appropriate for a broad range of people living with HIV.”
In 2017, there were approximately 140,000 people newly diagnosed
with HIV in China. The number of diagnoses has increased
significantly in recent years, partially due to expanded screening.
At the same time, the number of people living with HIV and
receiving antiretroviral treatment has also increased steadily. In
2003, the government of China began providing free antiretroviral
treatment to all persons living with HIV.
“Gilead supports China’s efforts to address the HIV epidemic and
we are pleased to offer Genvoya as a new treatment option for
people living with HIV in China,” said John F. Milligan, PhD,
Gilead’s President and Chief Executive Officer. “As part of our
TAF-based portfolio of treatments, we believe Genvoya’s safety and
efficacy profile may help to address the long-term health needs of
China’s HIV patient population.”
Genvoya was studied in a Phase 3 HIV clinical program in more
than 3,500 patients across 21 countries, including treatment-naïve,
virologically suppressed, renally impaired and adolescent patients.
The approval is supported by 144-week data from two Phase 3
double-blind studies (Studies 104 and 111) among 1,733
treatment-naïve patients in which the regimen met the primary
endpoint of non-inferiority compared to Gilead’s Stribild®
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200
mg/tenofovir disoproxil fumarate 300 mg or E/C/F/TDF) at Week 48.
At Week 48, 92.4 percent (n=800/866) of patients taking Genvoya and
90.4 percent (n=784/867) of patients taking Stribild achieved HIV-1
RNA levels less than 50 copies/mL
Additionally, the approval is supported by a Phase 3 study
(Study 109) evaluating Genvoya among virologically suppressed
patients who switched from TDF-based regimens. The study enrolled
1,436 subjects and 1,196 had reached the 48-week time point at the
time of filing. Among those patients, Genvoya was found to be
statistically non-inferior to the TDF-based regimens based on the
percentages of patients with HIV-1 RNA levels less than 50
copies/mL at Week 48. Patients receiving Genvoya also demonstrated
improvements in certain bone and renal laboratory parameters
compared to those treated with the TDF-based regimens. Finally,
data from Phase 3 studies evaluating Genvoya among adolescents and
adults with mild-to-moderate renal impairment supported the
approval.
Genvoya does not cure HIV infection or AIDS.
IMPORTANT SAFETY INFORMATION AND
INDICATION FOR GENVOYA IN U.S.
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS
B
- 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 (FTC) 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,
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.
- 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: Prior to or when initiating
Genvoya and during therapy, assess serum creatinine, CrCl, urine
glucose, and urine protein in all patients on a clinically
appropriate schedule. In patients with chronic kidney disease, also
assess serum phosphorus. If serum creatinine increases >0.4
mg/dL from baseline, closely monitor for renal safety.
- Lactic acidosis and severe
hepatomegaly with steatosis: Fatal cases have been reported
with the use of nucleoside analogs, including FTC and TDF.
Discontinue Genvoya if clinical or laboratory findings suggestive
of lactic acidosis or pronounced hepatotoxicity develop, including
hepatomegaly and steatosis in the absence of marked transaminase
elevations.
Adverse reactions
- Common adverse reactions
(incidence ≥5%; all grades) in clinical studies were nausea (11%),
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 FTC and tenofovir and the risk of adverse reactions.
Dosage and administration
- Dosage: Patients 12 years and
older who weigh ≥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.
- Prior to or when initiating:
Test patients for HBV infection.
- Prior to or when initiating, and
during treatment: On a clinically appropriate schedule, assess
serum creatinine, CrCl, urine glucose, and urine protein in all
patients. In patients with chronic kidney disease, assess serum
phosphorus.
Pregnancy and Lactation
- Pregnancy: There is insufficient
human data on the use of Genvoya during pregnancy. An
Antiretroviral Pregnancy Registry (APR) has been established.
Available data from the APR for FTC shows no difference in the
rates of birth defects compared with a US reference
population.
- Lactation: Women infected with
HIV-1 should be instructed not to breastfeed, due to the potential
for HIV-1 transmission.
Genvoya is indicated in the United States as a complete regimen
for the treatment of HIV-1 infection in adults and pediatric
patients weighing at least 25 kg who have no antiretroviral (ARV)
treatment history or to replace the current ARV regimen in patients
who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a
stable ARV regimen for ≥6 months with no history of treatment
failure and no known resistance to any component of Genvoya.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
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. 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 March 31, 2018, 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, including
BOXED WARNING, for Genvoya is available at
www.gilead.com.
Genvoya and Stribild 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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