Market Overview

China National Drug Administration Approves Gilead's Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), a Single Tablet Regimen for the Treatment of HIV-1 Infection

Share:

- 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.

View Comments and Join the Discussion!