Daklinza and Sunvepra combination approved for genotype 1b,
the most common chronic hepatitis C (HCV) genotype in China;
combination has a 91-99% cure rate
Daklinza also approved in China for use in combination with
other agents, including sofosbuvir, for HCV genotypes 1-6
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the
China Food and Drug Administration (CFDA) has approved a
direct-acting antiviral regimen comprised of Daklinza®
(daclatasvir) and Sunvepra® (asunaprevir), for the treatment of
treatment-naive or -experienced patients, with or without
compensated cirrhosis, infected with genotype 1b chronic hepatitis
C virus (HCV). This is China’s first all-oral, interferon- and
ribavirin-free HCV treatment regimen. In addition, Daklinza has
been approved in China for combination use with other agents,
including sofosbuvir, for adult patients with HCV genotypes 1-6
infection. This is the only all-oral pan-genotypic regimen
recommended by China’s HCV Prevention and Treatment Guideline.
Daklinza must not be administered as monotherapy. Sofosbuvir is
under review by the CFDA, and is not currently licensed in
China.
In more than 60 countries, Daklinza is approved as part of a
regimen with either Sunvepra or sofosbuvir. In China,
Daklinza-based regimens provide a shorter treatment duration (12 or
24 weeks) compared to 48 weeks of treatment with previously
approved regimens. The Daklinza and Sunvepra regimen is already
approved by regulatory authorities in multiple countries across the
Asia Pacific, Latin America, and Eastern Europe regions. Sunvepra
is not approved in the United States.
“The burden of HCV in China is extremely high, and now for the
first time, we have an all-oral treatment option in the combination
of Daklinza and Sunvepra, which is a significant step forward for
patients and doctors alike,” said Hui Zhuang, a professor at the
Beijing University Medical School and a member of the Chinese
Academy of Engineering. “This new option helps to address many of
the unmet needs for our HCV genotype 1b patients, and is also
included in the latest edition of China’s HCV Prevention and
Treatment Guideline.”
The approval is based primarily upon results of the first
completed Phase 3 036 trial of the Daklinza and Sunvepra regimen
for HCV among Chinese patients, which was published in the November
2016 issue of the Journal of Gastroenterology and Hepatology. In
the trial, 91% (145/159) of genotype 1b patients who had been
previously interferon-ineligible or interferon-intolerant achieved
sustained virologic response (“SVR”, or cure) at post-treatment
week 24. The cure rate was higher, at 99%, in patients without
baseline NS5A resistance-associated variants (RAVs; L31M or Y93H;
n=137/139).
As detailed in the published Phase 3 trial, one death (0.6%),
five on-treatment serious adverse events (3%), and three grade 4
laboratory abnormalities (2%) occurred on-treatment; none were
considered related to study drugs. Two patients (1%) discontinued
due to adverse events (AEs). The most common grade 1–4 on-treatment
AEs (>5% of patients) were platelet count decrease (14, 9%),
upper respiratory tract infection (13, 8%), ALT increase (a
diagnostic indication of liver disease or damage) (11, 7%),
neutrophil count decrease (11, 7%), monocyte (large white blood
cell) count decrease (10, 6%), white blood cell count decrease (10,
6%), thrombocytopenia (decrease in the number of platelets in the
blood) (10, 6%), and pruritus (itchiness) (9, 6%); most were mild
or moderate in intensity. Treatment was generally well-tolerated
regardless of cirrhosis status.
“We are proud to build on our legacy, infrastructure and
experience in treating viral hepatitis throughout Asia by bringing
Daklinza-based regimens to patients in China,” said Murdo Gordon,
executive vice president and chief commercial officer,
Bristol-Myers Squibb. “Beginning with our efforts to treat chronic
hepatitis B, Bristol-Myers Squibb has been committed to combating
viral hepatitis in China for over a decade.”
HCV represents a significant public health burden in China and
is now the fourth most commonly reported infectious disease
countrywide, with an estimated 10 million people currently living
with the disease. Until now, standard of care in China has been
interferon- and ribavirin-containing regimens which have left some
patient groups with unmet needs. The cure rate for interferon- and
ribavirin- containing regimens varies in a number of recent Chinese
studies. In CCgenos, a real-world observation study, the cure rate
for interferon- and ribavirin- containing regimens among GT-1b
naïve patients is 62.4%.
Karl Lintel, MD, President of Bristol-Myers Squibb (China)
Investment Co. Ltd and the Sino-American Shanghai Squibb
Pharmaceutical Co., commented, “Today’s approval of Daklinza and
Sunvepra is great news for patients in China, as we continue the
global fight against chronic hepatitis C. This milestone is
testament to our ongoing collaboration with multiple stakeholders,
and aligning with government policies to provide continuing support
to HCV patients at the community level.”
Bristol-Myers Squibb is committed to working with stakeholders
to seek timely reimbursement for Daklinza and Sunvepra at the
national and provincial levels, to ensure patients have access to
these important products.
About the 036 Clinical Trial
In the multi-center Asian study, interferon-ineligible and
-intolerant patients with genotype 1b infection received Daklinza
60 mg tablets once-daily plus Sunvepra 100 mg soft capsules
twice-daily for 24 weeks. Of the 159 patients enrolled, 127 were
from mainland China. The primary endpoint was SVR at post-treatment
Week 24 (SVR24).
In the overall study population, the SVR24 was 91% (145/159) and
was similarly high in cirrhotic patients (47/52, 90%). SVR24 rates
were higher (137/139) [99%]) in patients without baseline NS5A RAVs
(L31M or Y93H), and lower in patients with baseline NS5A RAVs (8/19
[42%]).
Prevalence of baseline NS5A RAVs was 12% (19/159) overall, and
8% in mainland China patients (10/127). HCV NS5A RAVs exist
naturally (albeit in lower prevalence vs wildtype) and can emerge
after virologic response failure. Screening for the presence of
specific NS5A mutations can help physicians determine the most
suitable patients for treatment by identifying those most likely to
achieve cure with an NS5A-containing regimen.
Data from other studies conducted outside of China investigating
Daklinza in combination with sofosbuvir were also considered as
part of the approval.
About the 114 Clinical Trial
In a multi-center study, treatment-naive patients with genotype
1b infection received Daklinza 60 mg tablets once-daily plus
Sunvepra 100 mg soft capsule twice-daily for 24 weeks. Of the total
206 patients, 161 were from mainland China. Patients were
randomized 3:1 into two treatment arms: an immediate Daklinza and
Sunvepra treatment group (n=155) or a placebo-deferred Daklinza and
Sunvepra treatment group (n=52). The primary endpoint was SVR at
post-treatment Week 12 (SVR12) in the immediate treatment arm, for
comparison with the historical SVR rate achieved with pegIFN/RBV
(70%).
The SVR12 rate was 92% in treatment-naive patients with HCV
genotype 1b infection in the immediate treatment arm. Baseline
NS5A-L31 or Y93H polymorphisms were present in 11% (17/154) of
these patients. The SVR12 rate was 96% (132/137) in patients
without these baseline polymorphisms; 89% (17/19) with cirrhosis,
97% (115/118) without cirrhosis.
Discontinuations due to AEs were infrequent (1%). The most
common AEs (any grade, ≥5%) in the overall population were ALT
increase, upper respiratory tract infection, hypertension, AST
elevation, INR elevation, blood bilirubin elevation, and
fatigue.
Bristol-Myers Squibb’s Leadership in Viral Hepatitis
Bristol-Myers Squibb’s heritage in virology in China began with
Baraclude® (entecavir), a market-leading oral treatment for
patients suffering with chronic hepatitis B virus (CHBV). Baraclude
is indicated in China for the treatment of chronic hepatitis B
virus infection in adults with evidence of active viral replication
and either evidence of persistent elevations in serum alanine
aminotransferase (ALT) or histologically active disease. Since its
approval in China in 2005, Bristol-Myers Squibb has worked to not
only provide access to Baraclude, but also to coordinate with
government, local hospitals and physicians, and NGOs to raise the
standard of care and improve the quality of life and survival of
patients with HBV. In China, more than 1 million patients have been
treated with Baraclude, and Asia has accounted for more than
two-thirds of all Baraclude prescriptions.
Since 2002, the Bristol-Myers Squibb Foundation also has been
leading efforts at the community level in Asia in HBV and HCV
awareness, destigmatization, prevention, and care through the
Delivering Hope program. The multi-pronged program includes a
variety of disease education and vaccination efforts, including
prevention of the most common means of transmission, from mother to
child. It also includes capacity building, and training in
partnership with local NGOs, governments and healthcare workers. In
China alone, more than 8 million people at high risk of hepatitis
infection across 28 provinces have benefitted from these programs
over the past decade. The Foundation has committed more than $9.6
million (U.S.) in grants to a diverse group of organizations for
programs targeting specific populations.
About Daclatasvir
Daclatasvir, marketed as Daklinza, is a NS5A replication complex
inhibitor which targets the NS5A protein by directly disrupting its
normal function. The NS5A protein plays essential roles in the HCV
viral life cycle, including viral RNA replication and virion (viral
particle) assembly. Daklinza is approved by the U.S. Food and Drug
Administration (FDA) for use with sofosbuvir, with or without
ribavirin, for the treatment of patients with HCV genotype 1 or
genotype 3 infection. Sustained virologic response (SVR12) rates
are reduced in HCV genotype 3-infected patients with cirrhosis
receiving Daklinza in combination with sofosbuvir for 12 weeks.
Daklinza is approved by the European Medicines Agency (EMA) for
patients with HCV genotypes 1, 3, or 4.
Test all patients for evidence of current or prior hepatitis B
virus (HBV) infection before initiating treatment with Daklinza.
HBV reactivation has been reported in HCV/HBV coinfected patients
who were undergoing or had completed treatment with HCV direct
acting antivirals and were not receiving HBV antiviral therapy.
Some cases have resulted in fulminant hepatitis, hepatic failure,
and death. Monitor HCV/HBV coinfected patients for hepatitis flare
or HBV reactivation during HCV treatment and post-treatment
follow-up. Initiate appropriate management for HBV infection as
clinically indicated. Please see full Important Safety Information
below for more details.
About Asunaprevir
Asunaprevir, marketed as Sunvepra, is an NS3 protease inhibitor,
an agent that binds to the NS3 protein of the HCV virus to block
its activity. The NS3/4A protease plays an essential role in the
assembly of the viral replication complex. Sunvepra is approved in
17 countries around the world, including in the Asia Pacific, Latin
America, and Eastern Europe regions; Sunvepra is not approved in
the United States. Sunvepra is approved as part of a regimen with
Daklinza for the treatment of HCV genotype 1b infection in adult
patients. For patients receiving Sunvepra-containing regimens,
frequent monitoring of liver enzymes (alanine aminotransferase
(ALT), aspartate aminotransferase (AST)) and bilirubin is required
until completion of therapy.
About Bristol-Myers Squibb in HCV
Bristol-Myers Squibb is focused on helping to eradicate
hepatitis C around the world, with a primary emphasis on
difficult-to-treat patients, including those millions in countries
where population-based HCV solutions remain a high unmet need.
In July 2014, Japan became the first country in the world to
approve the use of a daclatasvir-based regimen for the treatment of
chronic hepatitis C. Since then, daclatasvir-based regimens have
been approved in more than 60 countries across North, Central and
South America, Europe, the Middle East and the Asia-Pacific
region.
U.S. Indication and Important Safety Information - Daklinza™
(daclatasvir)
INDICATIONS
Daklinza™ (daclatasvir) is indicated for use with sofosbuvir,
with or without ribavirin, for the treatment of patients with
chronic hepatitis C virus (HCV) genotype 1 or genotype 3
infection.
Limitations of Use:
- Sustained virologic response (SVR12)
rates are reduced in HCV genotype 3-infected patients with
cirrhosis receiving Daklinza in combination with sofosbuvir for 12
weeks.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS
COINFECTED WITH HCV AND HBV
- Test all patients for evidence of
current or prior hepatitis B virus (HBV) infection before
initiating treatment with Daklinza. HBV reactivation has been
reported in HCV/HBV coinfected patients who were undergoing or had
completed treatment with HCV direct acting antivirals and were not
receiving HBV antiviral therapy. Some cases have resulted in
fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV
coinfected patients for hepatitis flare or HBV reactivation during
HCV treatment and post-treatment follow-up. Initiate appropriate
management for HBV infection as clinically indicated.
CONTRAINDICATIONS
- When used in combination with other
agents, the contraindications applicable to those agents are
applicable to the combination regimen; refer to the respective
prescribing information.
- Drugs contraindicated with
Daklinza: strong inducers of CYP3A that may lead to loss of
efficacy of Daklinza include, but are not limited to: phenytoin,
carbamazepine, rifampin, St. John’s wort (Hypericum
perforatum).
WARNINGS AND PRECAUTIONS
- Risk of Hepatitis B Virus
Reactivation in Patients Coinfected with HCV and HBV (additional
information): HBV reactivation has also been reported in
patients receiving certain immunosuppressant or chemotherapeutic
agents; the risk of HBV reactivation may be increased in these
patients.
- Risk of Adverse Reactions or Loss of
Virologic Response Due to Drug Interactions: Coadministration
of Daklinza and other drugs may result in known or potentially
significant drug interactions. Interactions may include the loss of
therapeutic effect of Daklinza and possible development of
resistance, dosage adjustments for other agents or Daklinza,
possible clinically significant adverse events from greater
exposure for the other agents or Daklinza.
- Serious Symptomatic Bradycardia When
Coadministered with Sofosbuvir and Amiodarone: Post-marketing
cases of symptomatic bradycardia and cases requiring pacemaker
intervention have been reported when amiodarone is coadministered
with sofosbuvir in combination with another direct-acting
antiviral, including Daklinza. A fatal cardiac arrest was reported
with ledipasvir/sofosbuvir.
- Coadministration of amiodarone with
Daklinza in combination with sofosbuvir is not recommended. For
patients taking amiodarone who have no alternative treatment
options, patients should undergo cardiac monitoring, as outlined in
Section 5.3 of the prescribing information.
- Patients also taking beta blockers or
those with underlying cardiac comorbidities and/or advanced liver
disease may be at increased risk for symptomatic bradycardia with
coadministration of amiodarone.
- Bradycardia generally resolved after
discontinuation of HCV treatment.
- Risks Associated with Ribavirin
Combination Treatment: If ribavirin is used as part of the
regimen, the warnings and precautions for ribavirin, particularly
the pregnancy avoidance warning, apply. See the ribavirin full
prescribing information for complete information.
ADVERSE REACTIONS
- In clinical trials (ALLY 2, 3) with the
Daklinza and sofosbuvir regimen, the most common adverse
reactions (≥5%) were, respectively: headache (8%, 14%), fatigue
(15%, 14%), nausea (9%, 8%), diarrhea (7%, 5%).
- In clinical trials (ALLY 1) with
Daklinza, in combination with sofosbuvir and ribavirin, the
most common adverse reactions (≥5%) were, in the cirrhosis
cohort and the post-liver transplantation cohort, respectively:
headache (12%, 30%), anemia (20%, 19%), fatigue (15%, 17%), nausea
(15%, 6%), rash (8%, 2%), diarrhea (3%, 6%), insomnia (3%, 6%),
dizziness (0, 6%), somnolence (5%, 0).
DRUG INTERACTIONS
- CYP3A: Daklinza is a substrate.
Moderate or strong inducers may decrease plasma levels and effect
of Daklinza. Strong inhibitors (e.g., clarithromycin, itraconazole,
ketoconazole, ritonavir) may increase plasma levels of
Daklinza.
- P-gp, OATP 1B1 and 1B3, and
BCRP: Daklinza is an inhibitor, and may increase exposure to
substrates, potentially increasing or prolonging their adverse
effect.
See Sections 4, 7, and 12.3 of the Daklinza Full Prescribing
Information for additional established and other potentially
significant drug interactions and related dose modification
recommendations. Refer to the prescribing information for other
agents in the regimen for drug interaction information.
DAKLINZA IN PREGNANCY
- No adequate human data are available to
determine whether or not Daklinza poses a risk to pregnancy
outcomes. Animal studies of Daklinza at exposure above the
recommended human dose have shown maternal and embryofetal
toxicity.
- If Daklinza and sofosbuvir are
administered with ribavirin, the information for ribavirin with
regard to pregnancy testing, contraception, and infertility also
applies to this combination regimen. Refer to the ribavirin
prescribing information.
LACTATION
- It is not known whether Daklinza is
present in human milk, affects human milk production, or has
effects on the breastfed infant. Daklinza was present in the milk
of lactating rats. The development and health benefits of
breastfeeding should be considered along with the mother’s clinical
need for Daklinza and any potential adverse effects on the
breastfed child from Daklinza or from the underlying
condition.
- When Daklinza is administered with
ribavirin, the nursing mothers’ information for ribavirin also
applies to this combination regimen. Refer to the nursing mothers’
information in the ribavirin prescribing information.
Please see Full Prescribing Information, including Boxed
WARNING here.
U.S. Indication and Important Safety Information - BARACLUDE®
(entecavir):
INDICATION
BARACLUDE (entecavir) is indicated for the treatment of chronic
hepatitis B virus (HBV) infection in adults and pediatric patients
2 years of age or older with evidence of active viral replication
and either evidence of persistent elevations in serum
aminotransferases (ALT or AST) or histologically active
disease.
The following points should be considered when initiating
therapy with BARACLUDE:
- In adult patients, this indication is
based on clinical trial data in nucleoside-inhibitor
treatment-naïve and lamivudine-resistant subjects with
HBeAg-positive and HBeAgnegative HBV infection and compensated
liver disease and a more limited number of subjects with
decompensated liver disease.
- In pediatric patients 2 years of age
and older, this indication is based on clinical trial data in
nucleoside-inhibitor-treatment-naïve and in a limited number of
lamivudine experienced subjects with HBeAg-positive chronic HBV
infection and compensated liver disease.
IMPORTANT SAFETY INFORMATION
WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS
CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND
HEPATOMEGALY
- Severe acute exacerbations of
hepatitis B have been reported in patients who have discontinued
anti-hepatitis B therapy, including entecavir. 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. If appropriate, initiation of
anti-hepatitis B therapy may be warranted.
- Limited clinical experience suggests
there is a potential for the development of resistance to HIV
(human immunodeficiency virus) nucleoside reverse transcriptase
inhibitors if BARACLUDE is used to treat chronic HBV infection in
patients with HIV infection that is not being treated. Therapy with
BARACLUDE is not recommended for HIV/HBV co-infected patients who
are not also receiving highly active antiretroviral therapy
(HAART).
- Lactic acidosis and severe
hepatomegaly with steatosis, including fatal cases, have been
reported with the use of nucleoside analogues, alone or in
combination with antiretrovirals.
Warnings and Precautions
- Before initiating BARACLUDE therapy,
HIV antibody testing should be offered to all patients. BARACLUDE
has not been studied as a treatment for HIV infection and is not
recommended for this use.
- Lactic acidosis with BARACLUDE use has
been reported, often in association with hepatic decompensation,
other serious medical conditions, or drug exposures. Patients with
decompensated liver disease may be at higher risk for lactic
acidosis. BARACLUDE should be suspended in any patient who develops
clinical or laboratory findings suggestive of lactic acidosis or
pronounced hepatotoxicity.
Adverse Reactions
- In clinical trials in patients with
compensated liver disease, the most common (≥3%) adverse reactions
of any severity with at least a possible relation to study drug for
BARACLUDE-treated subjects were headache, fatigue, dizziness, and
nausea. In these trials, the most common adverse reactions of
moderate to severe intensity (grades 2-4) were diarrhea, dyspepsia,
nausea, vomiting, fatigue, headache, dizziness, somnolence, and
insomnia.
- In the decompensated liver disease
trial, the most common adverse reactions of any severity among
patients treated with BARACLUDE, regardless of causality, included:
peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic
encephalopathy (10%), and upper respiratory infection (10%). In
this trial, 18% (18/102) of BARACLUDE patients and 20% (18/89) of
adefovir patients died during the first 48 weeks of therapy. The
majority of those deaths were due to liver related causes.
Drug Interactions
- BARACLUDE (entecavir) is primarily
eliminated by the kidneys; therefore coadministration of BARACLUDE
with drugs that reduce renal function or compete for active tubular
secretion may increase serum concentrations of either entecavir or
the coadministered drug. Patients should be monitored closely when
receiving BARACLUDE with other renally-eliminated drugs.
Pregnancy and Nursing Mothers
- There are no adequate and
well-controlled studies of BARACLUDE in pregnant women. BARACLUDE
should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
- There are no studies on the effect of
BARACLUDE on transmission of HBV from mother to infant. Therefore,
appropriate interventions should be used to prevent neonatal
acquisition of HBV.
- It is not known whether BARACLUDE is
excreted into human milk; however, many drugs are excreted into
breast milk. Due to the potential for serious adverse reactions in
nursing infants from BARACLUDE, risks and benefits should be
considered when deciding whether to discontinue breast-feeding or
discontinue BARACLUDE in nursing women.
Pediatric Use
- The adverse reactions observed in
pediatric patients who received treatment with BARACLUDE were
consistent with those observed in clinical trials of BARACLUDE in
adults. Adverse drug reactions reported in greater than 1% of
pediatric patients included abdominal pain, rash events, poor
palatability (“product taste abnormal”), nausea, diarrhea, and
vomiting.
- Due to limited data, in
lamivudine-experienced pediatric patients, Baraclude should be used
only if the potential benefit justifies the potential risk to the
child. Consideration should be given to the impact of BARACLUDE on
future treatment options.
Renal Impairment
- Dosage adjustment of BARACLUDE is
recommended for patients with a creatinine clearance <50 mL/min,
including those on hemodialysis or continuous ambulatory peritoneal
dialysis. There is insufficient data to recommend specific dosage
adjustments of BARACLUDE in pediatric patients with renal
impairment, however dosage adjustments similar to those for adults
should be considered.
Liver Transplant Recipients
Renal function must be carefully monitored both before and
during treatment with BARACLUDE in a liver transplant recipient who
has received or is receiving an immunosuppressant that may affect
renal function, such as cyclosporine or tacrolimus.
Duration of Therapy
- The optimal duration of treatment with
BARACLUDE for patients with chronic HBV infection and the
relationship between treatment and long-term outcomes such as
cirrhosis and hepatocellularcarcinoma are unknown.
Additional Information
BARACLUDE is not a cure for HBV. Patients should be advised that
treatment with BARACLUDE has not been shown to reduce the risk of
transmission of HBV to others through sexual contact or blood
contamination.
Please click here for the BARACLUDE full
prescribing information, including Boxed WARNINGS.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
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Bristol-Myers Squibb Forward Looking Statement
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on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
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should be evaluated together with the many uncertainties that
affect Bristol-Myers Squibb's business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31,
2016, in our Quarterly Reports on Form 10-Q and our Current Reports
on Form 8-K. Bristol-Myers Squibb undertakes no obligation to
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