– Healthcare Providers Reported High Rates
of Continued Care and Prescribing Behavior, Despite Practice-Site
Restrictions Affecting >90% of the Survey Respondents –
– Separate Clinical Data Presented Suggest
no Reported Increase in Sexual Health Risk Behavior From Baseline
Among DISCOVER Trial Study Participants –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced data
presented at the 23rd International AIDS Conference (AIDS 2020:
Virtual) evaluating the impact of COVID-19 shelter-in-place orders
(SIPOs) and PrEP utilization on HIV prevention strategies and
associated risk behaviors. Findings presented included results from
an online survey conducted by The American Academy of HIV Medicine
(AAHIVM) to understand potential changes in behavior among
pre-exposure prophylaxis (PrEP) users and prescribers in the United
States during the height of COVID-19 SIPOs. There were 598 total
respondents – 409 PrEP users and 189 PrEP prescribers. While most
prescribers (90 percent) reported recommending no change in PrEP
regimen, about one-third (33 percent) of PrEP users discontinued
therapy voluntarily, mostly (85 percent) due to low perceived HIV
risk associated with decreased sexual activity. Only 8 percent of
those users who discontinued PrEP cited inability to access PrEP
medications. Nearly all prescribers (95 percent) were able to
successfully prescribe PrEP despite limitations caused by
SIPOs.
PrEP users reported modified sexual behavior associated with HIV
risk during SIPOs, with 90 percent reporting no or fewer sexual
partners, and no or fewer sex events. From the providers who
completed the survey, 68 percent implemented telemedicine
practices; 59 percent indicated refilling PrEP medications while
postponing routine HIV/sexually transmitted infection (STI) and
laboratory tests, to be completed as soon as possible; and 15
percent opted to completely forgo testing and lab monitoring. Of
the 20 percent of responding providers who encountered PrEP users
with suspected STIs for which they could not obtain a test, 47
percent treated STIs empirically.
“Reducing the number of new HIV transmissions and ensuring
access to critical HIV prevention services must remain a public
health priority during this challenging time,” said Bruce Packett,
Executive Director, The American Academy of HIV Medicine. “These
data demonstrate the crucial role that technology-enabled care can
play in helping facilitate the safe and timely delivery of critical
public health services. My hope is that clinics and HIV prevention
providers can continue to adapt to changing circumstances by
offering expanded use of telehealth services and other innovative
tools to help meet the evolving needs of people at risk for
HIV.”
“Gilead is committed to supporting efforts to substantially
expand access to HIV prevention medications in the communities most
impacted. This includes, but is not limited to, the company’s
ongoing efforts to address the social and structural barriers to
care,” said Diana Brainard, MD, Senior Vice President and Virology
Therapeutic Area Head, Gilead Sciences. “As we work collectively
toward ending the epidemic, these survey findings can aid in our
efforts to assess and address such barriers.”
PrEP is a guideline recommended HIV prevention strategy, but
risk compensation could undermine potential benefits. Understanding
sexual decision-making and how PrEP is incorporated into existing
prevention strategies can help inform future PrEP implementation
efforts. DISCOVER is an ongoing multi-center randomized controlled
trial evaluating the safety and efficacy of Descovy (emtricitabine
200 mg/tenofovir alafenamide 25 mg) for PrEP® in men and
transgender women who have sex with men and are at risk for
sexually acquired HIV infection. Data presented on study
participant behavior in the DISCOVER trial found no longitudinal
changes in the mean number of participants’ sex partners;
condomless, insertive anal sex partners; or condomless, receptive
anal sex partners from baseline through 96 weeks of follow-up.
These findings suggest that an increase in risk behavior due to a
reduction in perceived risk did not occur in the DISCOVER
trial.
In the United States, Descovy for PrEP® is indicated to reduce
the risk of sexually acquired HIV-1 infection in at-risk adults and
adolescents weighing at least 35 kg, excluding individuals at risk
of HIV-1 from receptive vaginal sex, as effectiveness in this
population has not been evaluated.
Descovy has a Boxed Warning in its U.S. product label regarding
the risk of drug resistance when used for PrEP in undiagnosed early
HIV infection, and the risk of post-treatment acute exacerbation of
hepatitis B. See below for Indication and Important Safety
Information.
Key abstracts for HIV prevention data presented at AIDS 2020:
Virtual include:
Late-Breaker Submission OADLB01: Impact of COVID-19 Related
Shelter-in-Place Orders on PrEP Access, Usage
Details above.
Virtual Poster PEB0165: DISCOVER Study for HIV Pre-Exposure
Prophylaxis (PrEP): No Evidence of Risk Compensation in
Participants Taking F/TDF or F/TAF for Prep Through 96
Weeks
Baseline prevalence and longitudinal trends in HIV-associated
sexual risk behaviors during the DISCOVER trial suggest that risk
compensation, defined as an increase in risk behavior due to a
reduction in perceived risk, did not occur among study
participants. Over a 96-week follow-up period, sexual behavior was
assessed by a computer-assisted self-interview questionnaire,
including number of sex partners, condomless insertive anal sex
(CIAS) partners, and condomless receptive anal sex partners. Study
participants’ median age was 34 years; 9 percent (474) were black,
24 percent (1,318) were of Hispanic or Latinx ethnicity; 91 percent
(4,854) self-identified as gay, 7 percent (385) as bisexual, 1
percent (41) as heterosexual, and 1 percent (71) as transgender
women. Through 96 weeks, study participants reported a stable
number of total and condomless sexual partners.
Poster Discussion PDB0303: Persistently High Rates of
Sexually Transmitted Infections in the DISCOVER HIV PrEP
Trial
Through the 96 weeks of follow-up as part of the DISCOVER trial,
rates of STI acquisition remained consistent with baseline rates of
STIs. At baseline, 16.1 percent of study participants (430) in the
Descovy for PrEP® arm and 15.8 percent (421) in the Truvada
(emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for
PrEP® arm tested positive for gonorrhea or chlamydia at any
anatomic site; 11.3 percent (299) and 10.5 percent (279) tested
positive at the rectum. The overall incidence rate of gonorrhea or
chlamydia at any anatomic site was 85.7 and 83.1 per 100
person-years for the Descovy for PrEP® and the Truvada for PrEP®
arms respectively. In addition, the overall incidence rate of
rectal gonorrhea and chlamydia was 47.5 and 46.9 per 100
person-years for the Descovy for PrEP® and the Truvada for PrEP®
arms respectively. At 96 weeks, syphilis was found in 14.8 percent
and 15.2 percent in the Descovy for PrEP® and Truvada for PrEP®
arms, and the incidence rate was 9.9 and 9.3 per 100 person-years,
respectively.
Poster Discussion PDB0404: DISCOVER: Deep Sequencing with
Unique Molecular Identifiers for Evaluation of HIV-1 Drug
Resistance in the Pre-Exposure Prophylaxis Trial
A study examining standard and ultrasensitive resistance testing
from the subset of DISCOVER participants who acquired HIV infection
found using standard Sanger sequencing that four of the 20
participants who acquired HIV had the M184V mutation, all in the
Truvada for PrEP® arm. These four study participants all had
suspected baseline infection, and two of the four also had the
M184I mutation. Six study participants had additional mutations
related to non-study drug resistance and were presumed to be
transmitted.
Similar results were observed when using next generation
sequencing (UMI-NGS), with the addition of one participant with
M184V in the Descovy for PrEP® arm. Overall, drug resistance in the
DISCOVER study was most commonly seen in participants with
suspected baseline infections and in only one individual who became
infected while on study.
Descovy and Truvada do not prevent other sexually transmitted
infections or cure HIV or AIDS.
About the DISCOVER Trial The DISCOVER trial is a
multi-year global Phase 3 registrational clinical trial evaluating
the safety and efficacy of once-daily Descovy for PrEP® compared
with Truvada for PrEP® in men and transgender women who have sex
with men and are at risk for sexually acquired HIV infection. The
primary analysis of the study occurred when all participants had a
minimum of 48 weeks of follow-up and 50 percent of participants
reached 96 weeks of follow-up; the prespecified secondary analysis
occurred when 100 percent of participants reached 96 weeks of
follow-up. At both the primary and secondary endpoints, Descovy for
PrEP® demonstrated non-inferior efficacy to Truvada for PrEP®.
U.S. Important Safety Information for
Descovy for PrEP®
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY
FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT
ACUTE EXACERBATION OF HEPATITIS B
- DESCOVY FOR PrEP must be prescribed only to patients
confirmed to be HIV negative immediately prior to initiation and at
least every 3 months during use. Drug-resistant HIV-1 variants have
been identified with use of emtricitabine/tenofovir disoproxil
fumarate (FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1
infection. Do not initiate if signs or symptoms of acute HIV-1
infection are present unless HIV-negative status is
confirmed
- Severe acute exacerbations of hepatitis B have been reported
in patients infected with hepatitis B virus (HBV) who discontinued
products containing FTC and/or TDF and may occur with
discontinuation of DESCOVY. Closely monitor hepatic function with
both clinical and laboratory follow-up for at least several months
in patients with HBV who discontinue DESCOVY. If appropriate,
anti-hepatitis B therapy may be warranted
Contraindication
- DESCOVY FOR PrEP is contraindicated in patients with unknown or
positive HIV status
Warnings and precautions
- Comprehensive management to reduce risks:
- Use DESCOVY FOR PrEP to reduce the risk of HIV-1 infection as
part of a comprehensive strategy that includes adherence to daily
dosing and safer sex practices, including condoms, to reduce the
risk of sexually transmitted infections (STIs)
- HIV-1 risk factors: Behavioral, biological, or
epidemiologic HIV-1 risk factors may include, but are not limited
to: condomless sex, past or current STIs, self-identified HIV risk,
having sexual partners of unknown HIV-1 viremic status, or sexual
activity in a high-prevalence area or network
- Reduce STI risk: Counsel on the use of STI prevention
measures (e.g., consistent and correct condom use, knowledge of
partner’s HIV-1 viremic status, regular testing for STIs)
- Reduce potential for drug resistance: Only prescribe
DESCOVY FOR PrEP to patients confirmed to be HIV negative
immediately prior to initiation, at least every 3 months while
taking DESCOVY, and upon an STI diagnosis. HIV-1 resistance
substitutions may emerge in patients with undetected HIV-1
infection who are taking only DESCOVY because DESCOVY alone is not
a complete regimen for treating HIV-1
- Some HIV tests may not detect acute HIV infection. Prior to
initiating DESCOVY FOR PrEP, ask patients about potential recent
exposure events. If recent (<1 month) exposures are reported or
suspected, or symptoms of acute HIV infection (e.g., fever,
fatigue, myalgia, skin rash) are present, confirm HIV-negative
status with a test approved by the FDA for use in the diagnosis of
acute HIV infection
- If HIV-1 infection is suspected or if symptoms of acute
infection are present while taking DESCOVY FOR PrEP, convert the
DESCOVY FOR PrEP regimen to a complete HIV treatment regimen until
HIV-negative status is confirmed by a test approved by the FDA for
use in the diagnosis of acute HIV infection
- Counsel on adherence: Counsel patients to strictly
adhere to daily dosing, as efficacy is strongly correlated with
adherence. Some patients, such as adolescents, may benefit from
more frequent visits and counseling
- New onset or worsening renal impairment: Cases of acute
renal failure and Fanconi syndrome have been reported with the use
of tenofovir prodrugs. Do not initiate DESCOVY 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 DESCOVY 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 section) Lactic acidosis and severe
hepatomegaly with steatosis: Fatal cases have been reported with
the use of nucleoside analogs, including FTC and TDF. Discontinue
use 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 (≥2%) in the DESCOVY FOR
PrEP clinical trial were diarrhea, nausea, headache, fatigue, and
abdominal pain
Drug interactions
- Prescribing information: Consult the full Prescribing
Information for DESCOVY for more information, warnings, and
potentially significant drug interactions, including clinical
comments
- Metabolism: Drugs that inhibit P-gp can increase the
concentrations of tenofovir alafenamide (TAF), a component of
DESCOVY. Drugs that induce P-gp can decrease the concentrations of
TAF, which may lead to loss of efficacy
- Drugs affecting renal function: Coadministration of
DESCOVY 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: One tablet taken once daily with or without
food
- HIV screening: Test for HIV-1 infection immediately
prior to initiating, at least every 3 months during use, and upon
diagnosis of an STI (see Warnings and Precautions section)
- HBV screening: Test for HBV infection prior to or when
initiating DESCOVY
- Renal impairment and monitoring: Not recommended in
patients with creatinine clearance (CrCl) <30 mL/min. Prior to
or when initiating DESCOVY, and during use 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
U.S. Indication for Descovy for
PrEP® DESCOVY for PrEP is indicated in at-risk adults
and adolescents (≥35 kg) to reduce the risk of sexually acquired
HIV-1 infection, excluding individuals at risk from receptive
vaginal sex. HIV-1–negative status must be confirmed immediately
prior to initiation.
- Limitation of Use: DESCOVY FOR PrEP is not indicated in
individuals at risk of HIV-1 from receptive vaginal sex because
effectiveness in this population has not been evaluated.
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 Descovy for PrEP® and Truvada
for PrEP®, and the possibility that we are unable to complete one
or more of such trials in 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 Descovy and
Truvada, including BOXED WARNINGS, is available at
www.gilead.com.
Descovy, Descovy for PrEP, Truvada, Truvada for
PrEP and Gilead 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/20200708005354/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Brian Plummer, Media (202) 309-5207
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