Market Overview

Gilead Announces New Data on the Impact of Truvada® (Emtricitabine and Tenofovir Disoproxil Fumarate) for Pre-Exposure Prophylaxis (PrEP) on the Number of HIV Diagnoses in the United States


– Data Show That States with Highest Use of Truvada for PrEP®
Had Significant Declines in New HIV Infections –

Gilead Sciences, Inc. (NASDAQ:GILD) today announced results of a
retrospective nationwide analysis of the impact of Truvada (emtricitabine
200 mg and tenofovir disoproxil fumarate 300 mg tablets) for
pre-exposure prophylaxis (PrEP) use across all 50 U.S. states and the
District of Columbia. Conducted in collaboration with researchers at
Emory University Rollins School of Public Health and the Centers for
Disease Control and Prevention (CDC), these data demonstrate that use of
once-daily oral Truvada for PrEP has had an independent and significant
impact on the number of new HIV infections diagnosed in the United
States from 2012 to 2016. The data were presented at the 22nd
International AIDS Conference (AIDS 2018) in Amsterdam.

Truvada for PrEP is indicated in combination with safer sex practices to
reduce the risk of sexually acquired HIV-1 in at-risk adults and
adolescents weighing at least 35 kg. To take Truvada for PrEP,
individuals must be confirmed to be HIV-negative and be tested for HIV
immediately prior to initiating and at least every 3 months while taking
Truvada for PrEP. Truvada has a boxed warning in its product label
regarding the risks of drug resistance with the use of Truvada for PrEP
in undiagnosed early HIV infection and post treatment acute exacerbation
of hepatitis B. Further important safety information, adverse drug
reactions and prescribing considerations are included below.

In the analysis, states with the highest utilization of Truvada for PrEP
during this five year period (2012 to 2016) had significant declines in
the average number of HIV diagnoses, while there was an average increase
for the states with the lowest use. The impact of Truvada for PrEP use
occurred even after controlling for the effect of antiretroviral therapy
use in those living with HIV, known as treatment as prevention (TasP),
in a subset of 38 states and Washington, D.C., where virologic
suppression data was available.

"These data further validate the potential for significant public health
impacts of Truvada for PrEP to help reduce HIV transmission in the
U.S.," said Patrick Sullivan, Professor of Epidemiology at Rollins
School of Public Health, Emory University, and lead study author. "By
documenting significant declines in average new cases of HIV in states
where Truvada for PrEP has been most widely adopted, our analysis
emphasizes the importance of improving access to HIV screening and a
full range of prevention tools, including PrEP, in U.S. states."

The analysis of state-level data was based on National HIV Surveillance
System and national pharmacy data on HIV diagnoses and prevalence of use
of Truvada for PrEP from 2012 to 2016. Across all 50 states and
Washington, D.C., Truvada for PrEP use prevalence increased from 7.0 to
68.5 per 1,000 people at highest risk of HIV acquisition during the
five-year period, and the rate of new HIV diagnoses decreased
significantly from 15.7 to 14.5 per 100,000 people among the general

In the ten states with the highest prevalence of Truvada for PrEP use,
the pooled unadjusted estimated annual percent change (EAPC) of HIV
diagnoses was -4.7 percent. In the group of ten states with the lowest
prevalence of Truvada for PrEP use, the EAPC of HIV diagnoses was +0.9

To evaluate the independence of the effect of Truvada for PrEP uptake
from the effect of TasP, researchers analyzed data from a subset of 38
states and Washington, D.C., with viral suppression data (averaged for
available years from 2012 to 2014) among people living with HIV. This
analysis demonstrates that the rate of Truvada for PrEP uptake remained
significantly associated with declines in new HIV diagnoses after
controlling for state-level viral suppression.

"Since 2012, Truvada for PrEP has been an important component of HIV
prevention strategies. We are pleased to share these additional data at
AIDS 2018, correlating its uptake with declines in new diagnoses," said
Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences. "Gilead
remains committed to partnering with organizations that serve people at
risk for HIV, as well as those living with the disease, to increase
awareness of the potential impact of both Truvada for PrEP and TasP on
the HIV epidemic."

Truvada for PrEP — in combination with safer sex practices — was
approved in 2012 by the U.S. Food and Drug Administration (FDA) for HIV
prevention in at-risk adults, and was approved in 2018 for use in
at-risk adolescents weighing at least 35 kg.

Truvada does not prevent other sexually transmitted infections or cure
HIV infection or AIDS.



  • Truvada for PrEP must only be prescribed to individuals 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 Truvada for 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
    HBV-infected patients who discontinued Truvada. Hepatic function
    should be monitored closely with both clinical and laboratory
    follow-up for at least several months in patients with HBV after
    discontinuing Truvada. If appropriate, initiation of anti-hepatitis B
    therapy may be warranted


  • Do not use Truvada for PrEP in individuals with unknown or positive
    HIV status

Warnings and precautions: Comprehensive risk reduction strategies

  • Reduce HIV-1 risk: Truvada for PrEP is not always effective in
    preventing HIV-1. Use only as part of a comprehensive prevention
    strategy that includes safer sex practices, regular testing for HIV-1
    and other STIs, and counseling on reducing sexual risk behaviors
  • Reduce potential for drug resistance: Truvada for PrEP should
    only be used in individuals confirmed to be HIV-negative immediately
    prior to initiation, at least every 3 months while taking Truvada, and
    upon an STI diagnosis. HIV-1 resistance substitutions may emerge in
    individuals with undetected HIV-1 infection who are taking only
    Truvada. Truvada alone is not a complete regimen for treating HIV-1
    • HIV antibody tests may not detect acute HIV infection. If recent
      exposures are suspected or symptoms of acute HIV infection are
      present (e.g., fever, fatigue, myalgia, skin rash), delay
      initiating (≥1 month) or discontinue use and confirm HIV-negative
      status with a test approved by the FDA for the diagnosis of acute
      HIV infection
    • If a screening test indicates possible HIV-1 infection, convert
      the HIV-1 PrEP regimen to an HIV treatment regimen until
      HIV-negative status is confirmed.
  • Counsel on adherence: Counsel individuals to strictly adhere to
    their dosing schedule, as efficacy is strongly correlated with
    adherence. Some individuals, such as adolescents, may benefit from
    more frequent visits and counseling.

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal
    impairment and Fanconi syndrome have been reported with the use of
    tenofovir disoproxil fumarate (TDF). Truvada is not recommended in
    individuals with estimated creatinine clearance (CrCl) <60 mL/min.
    Avoid concurrent or recent use with a nephrotoxic agent. Acute renal
    failure has been reported after initiation of high dose or multiple
    NSAIDs in patients at risk for renal dysfunction; consider
    alternatives to NSAIDs in these patients. Monitor renal function in
    all patients – See Dosage and Administration
  • Bone effects: Decreases in bone mineral density (BMD) and
    mineralization defects, including osteomalacia associated with
    proximal renal tubulopathy, have been reported with the use of TDF
    Consider monitoring BMD in patients with a history of pathologic
    fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal
    cases have been reported with the use of nucleoside analogs, including
    Truvada. 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
  • Drug interactions: See Drug Interactions section. Consider the
    potential for drug interactions prior to and during use of Truvada and
    monitor for adverse reactions

Adverse reactions

  • Common adverse reactions (>2% and more frequently than placebo)
    of Truvada for PrEP in clinical trials were headache, abdominal pain,
    and weight loss

Drug interactions

  • Prescribing information: Consult the full Prescribing
    Information for Truvada for more information, warnings, and
    potentially significant drug interactions, including clinical comments
  • Hepatitis C antivirals: Coadministration with
    ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or
    sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor
    for adverse reactions
  • Drugs affecting renal function: Coadministration of Truvada
    with drugs that reduce renal function or compete for active tubular
    secretion may increase concentrations of emtricitabine and/or tenofovir

Pregnancy and lactation

  • Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been
    established. Available data from observational studies and the APR
    show no increase in the rate of major birth defects for Truvada
    compared with a US reference population. Consider HIV prevention
    methods, including Truvada for PrEP in at-risk women due to the
    potential increased risk of HIV-1 infection during pregnancy and
    mother to child transmission during acute HIV-1 infection
  • Lactation: Emtricitabine and tenofovir have been detected in
    human milk. Evaluate the benefits and risks of Truvada for PrEP in
    breastfeeding women, including the risk of HIV-1 acquisition due to
    nonadherence, and subsequent mother to child transmission. Health
    benefits of breastfeeding should be considered along with potential
    adverse effects of Truvada on the child, which are unknown

Dosage and administration

  • Dosage: One tablet once daily with or without food
  • HIV screening: Test for HIV-1 infection prior to initiating and
    at least every 3 months during treatment
  • HBV screening: Test for HBV infection prior to or when
    initiating treatment
  • Renal impairment and monitoring: Not recommended in individuals
    with CrCl <60 mL/min. In all patients, assess serum creatinine,
    estimated creatinine clearance, urine glucose, and urine protein on a
    clinically appropriate schedule. In patients with chronic kidney
    disease, also assess serum phosphorus


Truvada for PrEP (pre-exposure prophylaxis) is indicated to reduce the
risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who
are at risk for HIV, when used in combination with safer sex practices.
HIV-negative status must be confirmed immediately prior to initiation

  • If clinical symptoms of acute HIV-1 infection are present and recent
    exposures (<1 month) are suspected, delay initiation for at least 1
    month until HIV-negative status is reconfirmed. Alternatively, confirm
    HIV-negative status with a test cleared by the FDA to aid in the
    diagnosis of acute HIV-1 infection

Individuals at risk for sexually acquired HIV-1 may include those:

  • With HIV-1 infected partner(s), or
  • Who engage in sexual activity in a high prevalence area or social
    network and have additional risk factors, such as: inconsistent or no
    condom use, diagnosis of sexually transmitted infections (STIs),
    exchange of sex for commodities, use of illicit drugs or alcohol
    dependence, incarceration, or sexual partners of unknown HIV status
    with any of these risk factors

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 nearly 30 years, Gilead has been a leading innovator in the field of
HIV, driving advances in treatment, prevention and cure research. Today,
it's estimated that more than 10 million people living with HIV globally
receive antiretroviral therapy provided by Gilead or one of the
company's manufacturing partners.

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 Truvada for PrEP
and the possibility of unfavorable results from additional studies
involving Truvada for PrEP. 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 for Truvada, including BOXED
, is available at

Truvada, Truvada for PrEP, and Gilead are trademarks of Gilead
Sciences, Inc., or its related companies.

For more information on Gilead Sciences, please visit the company's
website at,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.

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