— More Than 35 Abstracts Across NASH, PSC and Viral Hepatitis
Reflect Ongoing Commitment to Advancing Liver Disease Research and
Patient Care —
FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that data from the
company’s research and development programs in nonalcoholic
steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and viral
hepatitis will be presented at The International Liver Congress™ 2019 in
Vienna, Austria from April 10-14, 2019. These data reflect Gilead’s
ongoing focus and commitment to advancing research and patient care
across the field of liver disease.
“For 20 years, Gilead has been focused scientifically on the treatment
of liver diseases and brought innovative medicines and access programs
to people around the world,” said John McHutchison, AO, MD, Chief
Scientific Officer, Head of Research and Development, Gilead Sciences.
“At this year’s International Liver Congress, we are proud to share new
data from studies that aim to improve our understanding of challenging
liver diseases such as PSC, enable broader NASH diagnosis rates and
strive to bring forward new therapies for patients with unmet medical
needs in NASH and viral hepatitis.”
Advanced Fibrosis due to NASH
Patients with advanced fibrosis due to NASH, defined as bridging
fibrosis (F3) or cirrhosis (F4), are at a significantly higher risk of
liver-related mortality. Gilead will share data on multiple
investigational compounds, noninvasive testing for NASH diagnosis and
Data being presented at the meeting highlight the potential utility of
investigational compounds in development to address this significant
A combination of the ACC inhibitor GS-0976 and the non-steroidal FXR
agonist GS-9674 improves hepatic steatosis and liver stiffness in
patients with nonalcoholic steatohepatitis (NASH): a proof-of-concept
study (poster #0352)
The addition of fenofibrate to a liver-targeted acetyl CoA carboxylase
inhibitor reverses plasma TG increases and positively impacts efficacy
The diagnosis of advanced fibrosis due to NASH currently requires a
liver biopsy, which is an invasive procedure that can lead to serious
complications. Data evaluating the use of noninvasive tests for the
identification of patients with advanced fibrosis will be presented at
Clinical utility and application of noninvasive tests of fibrosis in
selection of patients with advanced fibrosis due to NASH in the Phase
2 ATLAS trial (poster #0315)
Impact of age on routinely available noninvasive tests for the
discrimination of advanced fibrosis due to NASH in the Phase 3 STELLAR
trials of the ASK1 inhibitor selonsertib (poster #0273)
Data regarding patient-reported outcomes from Gilead’s ongoing
development program will also be presented.
What are the predictors of impairment of patient-reported outcomes in
non-alcoholic steatohepatitis (poster #0151)
Patients with non-alcoholic steatohepatitis (NASH) experience severe
impairment of health-related quality of life (HRQL) (poster #0348)
The presence of type 2 diabetes is independently associated with
impairment of patient-reported outcomes in patients with non-alcoholic
steatohepatitis (poster #0438)
Cilofexor (GS-9674), firsocostat (GS-0976) and selonsertib are
investigational compounds and are not approved by the U.S. Food and Drug
Administration (FDA) or any other regulatory authority. Their safety and
efficacy have not been established.
Primary Sclerosing Cholangitis (PSC)
PSC is a rare and chronic condition that causes inflammation and
scarring of the bile ducts, which may lead to liver failure. The natural
history and progression of the disease in patients are not well
understood. Data being presented help inform future clinical development
in PSC for which a large unmet need for effective therapy exists.
Validation of histologic and noninvasive measures of fibrosis as
surrogate endpoints of disease progression in patients with primary
sclerosing cholangitis (PSC) (oral presentation #0012)
Prospective evaluation of serum alkaline phosphatase variability and
prognostic utility in primary sclerosing cholangitis using controlled
clinical trial data (oral presentation #0016)
Methylation signatures in blood show accelerated epigenetic aging in
patients with primary sclerosing cholangitis compared to healthy
controls (poster #0024)
Viral Hepatitis Treatment and Cure
Gilead is committed to improving care for people living with chronic
hepatitis B virus (HBV) infection and delivering the potential for cure
to all chronic hepatitis C virus (HCV) patients. New HBV and HCV data
being presented include safety and efficacy findings with switching to
Vemlidy® (tenofovir alafenamide 25mg, TAF) treatment in
virologically suppressed HBV patients treated with tenofovir disoproxil
fumarate (TDF), and safety and efficacy results with Epclusa®
(sofosbuvir 400 mg/velpatasvir 100 mg) in difficult-to-cure HCV
patients. Further evidence of the use of Epclusa and Harvoni®
(ledipasvir 90mg/sofosbuvir 400mg) in a range of patient types and
populations in the real-world setting will also be presented.
A Phase 3 study comparing switching from tenofovir disoproxil fumarate
to tenofovir alafenamide with continued TDF treatment in
virologically-suppressed patients with chronic hepatitis B (CHB): week
48 efficacy and safety results (poster #0183)
Bone and renal safety are improved in chronic HBV patients switched to
tenofovir alafenamide (TAF) after either 2 or 3 years of prior
tenofovir disoproxil fumarate (TDF) treatment (poster #0158)
High efficacy and improvement in CPT class with sofosbuvir/velpatasvir
plus ribavirin for 12 weeks in patients with CPT C decompensated
cirrhosis (poster #0138)
Ledipasvir/sofosbuvir for 8, 12, or 24 weeks is safe and effective in
patients undergoing dialysis (poster #0144)
Global real-world evidence of sofosbuvir/velpatasvir as a simple,
effective regimen for the treatment of chronic hepatitis C patients:
Integrated Analysis of 12 clinical practice cohorts (oral presentation
Finally, as part of Gilead’s HBV cure program, the latest findings on
the potential role of investigational GS-9688, will be presented.
In vitro modulation by TLR8 agonist GS-9688 of multiple
regulatory cell types in patients with chronic hepatitis B (poster
EPCLUSA and HARVONI are each indicated in the U.S. for the treatment of
chronic HCV infection in patients with no cirrhosis or with compensated
cirrhosis: EPCLUSA for adults with genotypes 1-6; and HARVONI for adults
with genotypes 1, 4, 5 and 6. EPCLUSA in combination with ribavirin is
indicated in the U.S. for the treatment of chronic HCV infection in
patients with decompensated cirrhosis. VEMLIDY is indicated for the
treatment of chronic HBV infection in adults with compensated liver
disease. The US product labels for EPCLUSA, HARVONI, and VEMLIDY each
contain a BOXED WARNING: for EPCLUSA and HARVONI, the risk of HBV
reactivation in HCV/HBV co-infected patients; and for VEMLIDY, the risk
of post-treatment severe acute exacerbation of HBV. See below for U.S.
Important Safety Information.
The safety and efficacy of HARVONI in HCV patients undergoing dialysis
has not been established.
GS-9688 is an investigational compound and is not approved by the FDA or
any other regulatory authority. Its safety and efficacy has not been
For more information, including a complete list of abstract titles at
the meeting, please visit: [https://ilc-congress.eu/programme-highlights/].
US Important Safety Information and Indications
for Harvoni and Epclusa
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV
Test all patients for evidence of current or prior hepatitis B virus
(HBV) infection before initiating treatment with HARVONI or EPCLUSA. HBV
reactivation has been reported in HCV/HBV coinfected patients who were
undergoing or had completed treatment with HCV direct acting antivirals
(DAAs) and were not receiving HBV antiviral therapy. Some cases have
resulted in fulminant hepatitis, hepatic failure, and death. Cases have
been reported in patients who are HBsAg positive, in patients with
serologic evidence of resolved HBV, and also in patients receiving
certain immunosuppressant or chemotherapeutic agents; the risk of HBV
reactivation associated with treatment with HCV DAAs may be increased in
patients taking these other agents. Monitor HCV/HBV coinfected patients
for hepatitis flare or HBV reactivation during HCV treatment and
post-treatment follow-up. Initiate appropriate patient management for
HBV infection as clinically indicated.
If HARVONI or EPCLUSA is used in combination with ribavirin (RBV), all
contraindications, warnings and precautions, in particular pregnancy
avoidance, and adverse reactions to RBV also apply. Refer to RBV
Warnings and Precautions
Serious Symptomatic Bradycardia When Coadministered with Amiodarone:
Amiodarone is not recommended for use with HARVONI or EPCLUSA due to the
risk of symptomatic bradycardia, particularly in patients also taking
beta blockers or with underlying cardiac comorbidities and/or with
advanced liver disease. A fatal cardiac arrest was reported in a patient
taking amiodarone who was coadministered a sofosbuvir containing regimen.
In patients without alternative, viable treatment options, cardiac
monitoring is recommended. Patients should seek immediate medical
evaluation if they develop signs or symptoms of bradycardia.
Risk of Reduced Therapeutic Effect Due to Use with P-gp Inducers
and/or Moderate to Potent Inducers of CYP: Rifampin, St. John’s wort
and carbamazepine are not recommended for use with HARVONI or with
EPCLUSA. P-gp inducers may significantly decrease ledipasvir, sofosbuvir
and/or velpatasvir plasma concentrations. Moderate to potent inducers of
CYP2B6, CYP2C8 or CYP3A4 may significantly decrease sofosbuvir and/or
velpatasvir plasma concentrations.
The most common adverse reactions (≥10%, all grades) with HARVONI were
fatigue, headache, and asthenia.
The most common adverse reactions (≥10%, all grades) with EPCLUSA were
headache and fatigue; and when used with RBV in decompensated cirrhotics
were fatigue, anemia, nausea, headache, insomnia, and diarrhea.
HARVONI: Coadministration is not recommended with oxcarbazepine,
phenobarbital, phenytoin, rifabutin, rifapentine, and
tipranavir/ritonavir due to decreased concentrations of ledipasvir and
sofosbuvir; or with co-formulated
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due
to increased concentrations of tenofovir; or with simeprevir due to
increased concentrations of ledipasvir and simeprevir; or with
rosuvastatin due to increased concentrations of rosuvastatin.
EPCLUSA: Coadministration is not recommended with topotecan due
to increased concentrations of topotecan; or with proton-pump
inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin,
rifapentine, efavirenz, and tipranavir/ritonavir due to decreased
concentrations of sofosbuvir and/or velpatasvir.
Consult the full Prescribing Information for HARVONI and EPCLUSA for
more information on potentially significant drug interactions, including
INDICATION for HARVONI
HARVONI is indicated for the treatment of adults with chronic hepatitis
C virus genotype (GT) 1, 4, 5, or 6 infection without cirrhosis or with
compensated cirrhosis. HARVONI is used with ribavirin in GT 1 adults
with decompensated cirrhosis and in GT 1 or 4 adult liver transplant
recipients without cirrhosis or with compensated cirrhosis.
INDICATION for EPCLUSA
EPCLUSA is indicated for the treatment of adults with chronic hepatitis
C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with
compensated cirrhosis and in combination with ribavirin for those with
US Important Safety Information and Indication
BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may
result in severe acute exacerbations of hepatitis B. Hepatic function
should be monitored closely with both clinical and laboratory follow-up
for at least several months in patients who discontinue anti-hepatitis B
therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis
B therapy may be warranted.
Warnings and Precautions
Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected
Patients: Due to this risk, VEMLIDY alone should not be used for the
treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not
been established in HBV/HIV-1 coinfected patients. HIV antibody testing
should be offered to all HBV-infected patients before initiating therapy
with VEMLIDY, and, if positive, an appropriate antiretroviral
combination regimen that is recommended for HBV/HIV-1 coinfected
patients should be used.
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 VEMLIDY, there have been no
cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Patients
with impaired renal function and/or taking nephrotoxic agents (including
NSAIDs) are at increased risk of renal-related adverse reactions.
Discontinue VEMLIDY in patients who develop clinically significant
decreases in renal function or evidence of Fanconi syndrome. Monitor
renal function in all patients – See Dosage and Administration.
Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal
cases have been reported with the use of nucleoside analogs, including
tenofovir disoproxil fumarate. Discontinue VEMLIDY if clinical or
laboratory findings suggestive of lactic acidosis or pronounced
hepatotoxicity develop, including hepatomegaly and steatosis in the
absence of marked transaminase elevations.
Most common adverse reactions (incidence ≥5%; all grades) were headache,
abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea,
Coadministration of VEMLIDY with drugs that reduce renal function or
compete for active tubular secretion may increase concentrations of
tenofovir and the risk of adverse reactions.
Coadministration of VEMLIDY is not recommended with the following:
oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin,
rifapentine, or St. John’s wort. Such coadministration is expected to
decrease the concentration of tenofovir alafenamide, reducing the
therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein
(P-gp) and breast cancer resistance protein (BCRP) activity may lead to
changes in VEMLIDY absorption.
Consult the full prescribing information for VEMLIDY for more
information on potentially significant drug interactions, including
Dosage and Administration
- Testing Prior to Initiation: HIV infection.
Prior to or when initiating, and during treatment: On a
clinically appropriate schedule, assess serum creatinine, estimated
creatinine clearance, urine glucose, and urine protein in all
patients. In patients with chronic kidney disease, also assess serum
- Dosage in Adults: 1 tablet taken once daily with food.
Renal Impairment: Not recommended in patients with end stage
renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic
hemodialysis; in patients on chronic hemodialysis, on hemodialysis
days, administer VEMLIDY after completion of hemodialysis treatment.
Hepatic Impairment: Not recommended in patients with
decompensated (Child-Pugh B or C) hepatic impairment.
VEMLIDY is indicated for the treatment of chronic hepatitis B virus
infection in adults with compensated liver disease.
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 35
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
possibility of unfavorable results from ongoing and additional clinical
trials involving cilofexor, selonsertib, firsocostat and GS-9688.
Further, it is possible that the parties may make a strategic decision
to discontinue development of cilofexor, selonsertib, firsocostat and/or
GS-9688, and as a result, these compounds may never be successfully
commercialized. 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 Annual Report on Form 10-K for the year ended
December 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 for Epclusa, Harvoni and Vemlidy
including BOXED WARNINGS, are available at www.gilead.com.
Epclusa, Harvoni and Vemlidy 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.
Sung Lee, Investors
Arran Attridge, Media