– Older Adults With Diabetes, Hypertension,
Cardiovascular Disease, and Dyslipidemia Maintained High Rates of
Virologic Suppression After Switching to Biktarvy –
– Additional Data Presented Suggest the
Presence of Pre-Existing Resistance in Virologically Suppressed
Patients Switching to Biktarvy, Including Those With History of
Treatment Failure –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced data
demonstrating the safety and efficacy of the once-daily, single
tablet regimen Biktarvy® (bictegravir 50 mg/emtricitabine 200
mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically
suppressed adults ages 65 and older (n=140), including those with
common comorbidities such as diabetes (22 percent), hypertension
(55 percent), cardiovascular disease (24 percent), and
dyslipidemia, which is an abnormal amount of lipids in the blood
(59 percent). At 48 weeks, 92 percent of those who switched to
Biktarvy maintained virologic suppression, achieving HIV RNA<50
copies/mL. Across the studies, Biktarvy was generally well
tolerated. These data were evaluated as part of a pooled analysis
of four international trials and will be presented during the 23rd
International AIDS Conference (AIDS 2020: Virtual).
“As the number of older adults living with HIV grows, it’s
critical to optimize therapy to fit the unique needs of this key
population, including those with chronic conditions who may be on
multiple medications,” said Moti Ramgopal, MD, FACP, FIDSA, Medical
Director, Midway Immunology and Research Center. “By 2030, it is
projected that up to 70 percent of people living with HIV will be
50 years or older, the majority of whom will have at least one
other comorbidity. The data presented at AIDS 2020: Virtual showed
that adults 65 years and older who switched to Biktarvy maintained
viral suppression without a significant impact on lipid levels such
as cholesterol, weight, or interactions with other drugs they may
be taking for comorbidities.”
Gilead also announced a new data analysis from multiple studies
evaluating drug resistance, including the first study to
investigate a switch to Biktarvy in virologically suppressed study
participants (n=565) in which some of the participants had a
history of treatment failure or suspected pre-existing nucleoside
reverse transcriptase inhibitor resistance (NRTI-R). The study
showed infrequent and similar viral blips (when study participants
experienced a temporary viral load at or above 50 copies/mL) among
study participants switching to Biktarvy, as compared to the
comparator arm. The results support further evaluation of whether
the once-daily, single tablet regimen Biktarvy may potentially be
an effective and well-tolerated option for adults with a history of
treatment failure or pre-existing resistance. The use of Biktarvy
in individuals with a history of treatment failure or known
resistance to the components of Biktarvy is investigational.
Biktarvy is indicated in the United States as a complete regimen
for the treatment of HIV-1 infection in adults or pediatric
patients weighing at least 25 kg who have no antiretroviral (ART)
treatment history. While it is also indicated for adults and
pediatric patients weighing at least 25 kg who are virologically
suppressed and on a stable antiretroviral regimen, these people
must have no history of treatment failure and no known
substitutions associated with resistance to the individual
components of Biktarvy. Please see below for U.S. Important Safety
Information for Biktarvy, including a Boxed Warning on the risk of
post-treatment acute exacerbation of hepatitis B.
“These data presented at AIDS 2020: Virtual further reinforce
the potential of Biktarvy for use in a wide range of people living
with HIV, including those with treatment resistance, older adults
and those with certain common chronic conditions,” said Diana
Brainard, MD, Senior Vice President and Virology Therapeutic Area
Head, Gilead Sciences. “At Gilead, we are focused on continuing to
advance the scientific understanding of HIV treatment in a way that
will have a truly meaningful impact on the daily lives of those
affected by the epidemic, from young children to the growing number
of older adults who are living longer, healthier lives with
HIV.”
Key abstracts for HIV treatment data presented at AIDS 2020:
Virtual include:
Oral Presentation OAB0403: Pooled Analysis of 4 International
Trials of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
in Adults Aged 65 or Older Demonstrating Safety and Efficacy: Week
48 Results
A pooled analysis of four international trials (Studies 1844,
1878, 4030 and 4449) of virologically suppressed (HIV-1 RNA<50
copies/mL), treatment-experienced adults 65 years and older
evaluated the efficacy and safety of switching to Biktarvy. The
primary endpoint was HIV-1 RNA<50 copies/mL at week 48 as
defined by the U.S. Food and Drug Administration Snapshot
algorithm. Across the studies, 140 study participants with a median
age of 68 years were evaluated; 14 percent were female, and 88
percent were white. Medical history at baseline was significant for
diabetes (22 percent), hypertension (55 percent), cardiovascular
disease (24 percent), and dyslipidemia, which is an abnormal amount
of lipids in the blood (59 percent).
At week 48, the proportion with HIV RNA<50 copies/mL was 92
percent (129/140), showing that Biktarvy in older adults maintained
high rates of virologic suppression. In the studies, Biktarvy was
generally well-tolerated; 11 study participants experienced a grade
1 or 2 study drug-related adverse event (AE), four of which
discontinued the study. No participant experienced a grade 3 or 4
drug-related AE or virologic failure. Most common AEs were
nasopharyngitis and arthralgia (7 percent each).
Virtual Poster PEB0257: Baseline NRTI Resistance in
Suppressed Participants Did Not Lead to Viral Blips on
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) or
Dolutegravir (DTG)+F/TAF Through Week 48 in Study 380-4030
Study 4030 was the first study to prospectively investigate
switching to Biktarvy in virologically suppressed study
participants (n=565) in which some of the participants (25 percent)
had a history of treatment failure and/or known or suspected
pre-existing NRTI resistance. The aim of this additional analysis
of the 48-week study data was to analyze the occurrence of viral
blips in 565 suppressed study participants switching from DTG+F/TAF
or DTG+F/tenofovir disoproxil fumarate to Biktarvy or DTG+F/TAF. A
blip was defined as a post-baseline HIV-1 RNA value ≥50 c/mL
preceded and followed by HIV-1 RNA <50 c/mL.
In total, 15 study participants (2.7 percent) experienced a blip
through week 48 with similar blip frequencies between treatment
arms. No participant with blips qualified for genotypic and
phenotypic testing for emergent resistance. Viral blips were
infrequent and similar among study participants switching to
Biktarvy or DTG+F/TAF, and baseline NRTI resistance did not result
in a higher rate of blips. Blips did not lead to virologic failure
or resistance development using these triple therapy regimens.
Virtual Poster PEB0254: Prevalence and Risk Factors of
Pre-Existing NNRTI Resistance Among Suppressed PLWH in B/F/TAF
Switch Studies
This analysis investigated the prevalence of pre-existing
non-nucleoside reverse-transcriptase inhibitor resistance (NNRTI-R)
and associated risk factors across four clinical trials evaluating
the safety and efficacy of switching stably suppressed adults with
HIV-1 infection to Biktarvy.
Pre-existing drug resistance was assessed by historical
genotypes and/or retrospective proviral DNA genotyping. Stepwise
selection was used to identify potential risk factors for NNRTI-R
in a multivariate logistic regression model with variables
including participant demographics and baseline characteristics,
HIV disease measures, ART history, and other pre-existing HIV drug
resistance substitutions.
Baseline genotypic data were available for 1,995 study
participants. Altogether, 38 percent (754/1,995) of study
participants were previously treated with NNRTIs, and 7 percent
(145/1,995) were on a NNRTI-based regimen at baseline. NNRTI
resistance was the most frequently observed resistance class in
these studies. The high prevalence of NNRTI resistance among
suppressed people living with HIV and the risk factors associated
with NNRTI resistance underscore the importance of comprehensive
resistance assessments and medical history prior to switching to
NNRTI containing regimens.
The use of Biktarvy in individuals with a history of treatment
failure or known resistance to the components of Biktarvy is
investigational; this use is not approved by the U.S. FDA, and the
safety and efficacy of Biktarvy for this use has not been
established. Please see below for the U.S. Indication for
Biktarvy.
Biktarvy does not prevent other sexually transmitted infections
or cure HIV or AIDS.
U.S. Important Safety Information for
Biktarvy
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 BIKTARVY. Closely monitor hepatic
function with both clinical and laboratory follow-up for at least
several months in patients who are coinfected with HIV-1 and HBV
and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy
may be warranted.
Contraindications
- Coadministration: Do not use BIKTARVY with dofetilide or
rifampin.
Warnings and precautions
- Drug interactions: See Contraindications and Drug
Interactions sections. Consider the potential for drug interactions
prior to and during BIKTARVY 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 BIKTARVY, there have
been no cases of Fanconi syndrome or proximal renal tubulopathy
(PRT). Do not initiate BIKTARVY 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 BIKTARVY in patients who develop clinically significant
decreases in renal function or evidence of Fanconi syndrome. Renal
monitoring: Prior to or when initiating BIKTARVY and during
therapy, assess serum creatinine, CrCl, urine glucose, and urine
protein in all patients as clinically appropriate. In patients with
chronic kidney disease, assess serum phosphorus.
- Lactic acidosis and severe hepatomegaly with steatosis:
Fatal cases have been reported with the use of nucleoside analogs,
including FTC and TDF. Discontinue BIKTARVY 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
- Most common adverse reactions (incidence ≥5%; all
grades) in clinical studies through week 144 were diarrhea (6%),
nausea (6%), and headache (5%).
Drug interactions
- Prescribing information: Consult the full prescribing
information for BIKTARVY for more information on Contraindications,
Warnings, and potentially significant drug interactions, including
clinical comments.
- Enzymes/transporters: Drugs that induce P-gp or induce
both CYP3A and UGT1A1 can substantially decrease the concentration
of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or
inhibit both CYP3A and UGT1A1 may significantly increase the
concentrations of components of BIKTARVY. BIKTARVY can increase the
concentration of drugs that are substrates of OCT2 or MATE1.
- Drugs affecting renal function: Coadministration of
BIKTARVY 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 weighing ≥25 kg: 1 tablet taken once
daily with or without 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: As
clinically appropriate, 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 BIKTARVY during pregnancy. Dolutegravir, another integrase
inhibitor, has been associated with neural tube defects. Discuss
the benefit-risk of using BIKTARVY during pregnancy and conception.
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.
U.S. Indication for
Biktarvy
Biktarvy is indicated 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 those who are virologically
suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen
with no history of treatment failure and no known resistance to any
component of Biktarvy.
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.
For more than 30 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention,
testing and linkage to care, and cure research. Today, it’s
estimated that more than 12 million people living with HIV globally
receive antiretroviral therapy provided by Gilead or one of the
company’s manufacturing partners.
Gilead is committed to supporting the global health community to
quickly and effectively respond to serious and life-threatening
viral outbreaks worldwide. To that end, we are contributing our
antiviral expertise and resources to help investigate potential
treatments for patients with COVID-19.
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 possibility of unfavorable results from ongoing and
additional clinical trials involving Biktarvy, and the possibility
that we are unable to complete one or more of such trials on the
currently anticipated timelines or at all. All statements other
than statements of historical fact are statements that could be
deemed forward-looking statements. 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, 2020, 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. Prescribing Information for Biktarvy
including BOXED WARNING, is available at www.gilead.com.
Biktarvy, Gilead and the Gilead logo are
trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20200704005006/en/
Douglas Maffei, PhD, Investors (650) 522-2739 Brian Plummer,
Media (202) 309-5207
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