Market Overview

Data Published in The Lancet Shows High Efficacy at 96 Weeks for First Investigational Two-Drug, Long-Acting Injectable HIV Regimen


- Long-term data from the Phase 2b LATTE-2 study demonstrated
comparable antiviral activity to daily, oral 3-drug combination -

- Data presented as an oral late breaker at the 9th
International AIDS Society Conference, 23-26 July 2017, Paris, France -

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies
of Johnson & Johnson (Janssen) today announced that a regimen of two
investigational long-acting, injectable formulations of HIV medicines
—Janssen's rilpivirine and ViiV Healthcare's cabotegravir — given
together every 4 or 8 weeks was as effective as 3-drug oral
antiretroviral therapy (ART) at maintaining HIV-1 viral suppression
through 96 weeks (HIV-1 RNA <50 copies per mL). Results published in The
show that if approved, this first two-drug, long-acting
regimen could offer a highly effective suppressive maintenance therapy
for people living with HIV.

Viral suppression was achieved in 94 percent of those (n=108) receiving
injections every eight weeks, warranting further investigation.
Virologic response was also achieved by 87 percent (n=100) of those
receiving injections every four weeks versus 84 percent (n=47) receiving
oral ART therapy. In an unprecedented outcome, no virologic
non-responders to the long-acting regimen were observed in the four-week
group, as determined by the stringent FDA snapshot algorithm. Few
virologic non-responders were seen in the eight-weekly group (n=5 [4%]).
These results highlighted that the two-drug, long-acting regimen offered
durability of virologic response throughout almost 2 years of treatment.

"Results published in The Lancet strengthen the evidence that a
two-drug, long-acting regimen may offer an effective and acceptable
alternative for people who have achieved viral suppression but struggle
with daily, oral regimens to control their HIV," said Paul Stoffels
M.D., Chief Scientific Officer, Johnson & Johnson. "Non-adherence to
treatment remains a challenge for many people living with HIV and one of
the main drivers of resistance to HIV medicines. Our hope is to make HIV
treatment manageable for all by developing innovative solutions like
long-acting regimens."

In LATTE-2, patients with HIV-1 viral suppression on oral medication
(cabotegravir plus abacavir/lamivudine) were randomized 2:2:1 to
long-acting injections every four or eight weeks, or to daily oral
cabotegravir taken with abacavir and lamivudine.

High satisfaction was reported in the study by those receiving the
two-drug, long-acting regimen, which suggests it may provide a preferred
alternative for many people living with HIV who may not wish to consider
taking life-long oral therapy. The data are based on the observed case
data set of subjects who completed questionnaires at week 48 and week 96.

The two-drug, long-acting regimen was generally well tolerated, with no
drug-related serious adverse events and few adverse event-related
withdrawals. While injection-site reactions (ISRs) were common
(four-weekly group, 97% of patients; eight-weekly group, 96% of
patients), they were transient in nature, and mild or moderate in
severity. The long-term acceptability of administering chronic
intramuscular injections to patients was also demonstrated in LATTE-2,
with very few withdrawals resulting from ISRs (two patients [<1%]),
through 96 weeks.

The most commonly reported non-ISR adverse events were nasopharyngitis
(four-weekly group, 34%; eight-weekly group, 30%; oral cabotegravir plus
abacavir/lamivudine groups, 39%), diarrhea (four-weekly group, 28%;
eight-weekly group, 23%; oral cabotegravir plus abacavir/lamivudine
group, 20%), and headache (four-weekly group, 23%; eight-weekly group,
25%; oral cabotegravir plus abacavir/lamivudine group, 25%).

Two global Phase 3 switch studies, FLAIR (First Long-Acting Injectable
Regimen) and ATLAS (Antiretroviral Therapy as Long-Acting Suppression),
are currently examining the safety and efficacy of four weekly dosing
with the two-drug, injectable regimen. For more information on the
clinical trials, please visit:

These results will be presented in an oral abstract session at the 9th
International AIDS Society Conference on HIV Science (IAS 2017) at 12:00
on Monday 24 July 2017. Please visit for additional details
on the breadth of science being presented by Johnson & Johnson companies
and its partners.


About the LATTE 2 clinical trial (NCT02120352)

LATTE-2 is an ongoing Phase 2b, multicenter, parallel group, and
open-label study which recruited ART-naïve HIV-infected adults. Enrolled
patients who had a plasma HIV-1 RNA, <50 c/mL during 20-week Induction
Period (IP) with daily oral cabotegravir (CAB) 30 mg plus
abacavir/lamivudine 600 mg/300 mg were randomized 2:2:1 to intramuscular
injections every 4 weeks (long-acting cabotegravir 400 mg plus
rilpivirine 600 mg; two 2-mL injections) or every 8 weeks (long-acting
cabotegravir 600 mg plus rilpivirine 900 mg; two 3-mL injections), or to
continue receiving three-drug, oral ART in the Maintenance Period (MP).
The primary endpoints evaluated antiviral activity by FDA snapshot
algorithm, protocol defined virologic failure, and safety at 32 weeks in
the maintenance period. Antiviral activity, protocol-defined virologic
failures and safety events through 96 weeks for the maintenance
population were key secondary endpoints.

About cabotegravir

Cabotegravir is an investigational integrase strand transfer inhibitor
(INSTI) and is not approved by regulatory authorities anywhere in the
world. Cabotegravir is being developed by ViiV Healthcare as a
long-acting, nanosuspension formulation for intramuscular injection for
the treatment and prevention of HIV.

About EDURANT® (Rilpivirine)

EDURANT® (rilpivirine) is a prescription HIV medicine
that is used with other antiretroviral medicines to treat Human
Immunodeficiency Virus-1 (HIV-1) in patients:

  • Who have never taken HIV medicines before, and
  • Who have an amount of HIV in their blood (called "viral load") that is
    no more than 100,000 copies/mL. Your healthcare professional will
    measure your viral load.

EDURANT® should be taken in combination with other HIV
medicines. Your healthcare professional will work with you to find the
right combination of HIV medicines.

It is important that you remain under the care of your healthcare
professional during treatment with EDURANT®.

EDURANT® is not recommended for patients less than 12
years of age.

EDURANT® does not cure HIV infection or
AIDS. You should remain on your HIV medications without stopping to
ensure that you control your HIV infection and decrease the risk of
HIV-related illnesses. Ask your healthcare professional about how to
prevent passing HIV to other people.

Please read Important Safety Information below, and talk to your
healthcare professional to learn if EDURANT
® is
right for you.

Important Safety Information

Can EDURANT® be taken with other medicines?

EDURANT® may affect the way other medicines work and
other medicines may affect how EDURANT® works and may
cause serious side effects. If you take certain medicines with EDURANT®,
the amount of EDURANT® in your body may be too low and
it may not work to help control your HIV infection, and the HIV virus in
your body may become resistant to EDURANT® or other
HIV medicines that are like it. To help get the right amount of medicine
in your body, you should always take EDURANT® with a
meal. A protein drink alone does not replace a meal.

Do not take EDURANT® if:

  • Your HIV infection has been previously treated with HIV medicines
  • You are taking any of the following medicines:
    • Anti-seizure medicines: carbamazepine (Carbatrol®,
      Equetro®, Tegretol®,
      Tegretol-XR®, Teril®, Epitol®),
      oxcarbazepine (Trileptal®), phenobarbital
      (Luminal®), phenytoin (Dilantin®,
      Dilantin-125®, Phenytek®).
    • Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater®,
      Rifamate®, Rimactane®, Rifadin®),
      rifapentine (Priftin®) Proton pump inhibitor
      (PPI) medicine for certain stomach or intestinal problems:
      esomeprazole (Nexium®, Vimovo®),
      lansoprazole (Prevacid®), omeprazole (Prilosec®,
      Zegerid®), pantoprazole sodium (Protonix®),
      rabeprazole (Aciphex®).
    • More than 1 dose of the steroid medicine dexamethasone or
      dexamethasone sodium phosphate.
    • St. John's wort (Hypericum perforatum).
  • Especially tell your doctor if you take:
    • Rifabutin (Mycobutin®), a medicine to treat some
      bacterial infections). Talk to your doctor or pharmacist about the
      right amount of EDURANT® you should take if you
      also take rifabutin.
    • Medicines used to treat HIV.
    • An antacid medicine that contains aluminum, magnesium hydroxide,
      or calcium carbonate. Take antacids at least 2 hours before or at
      least 4 hours after you take EDURANT®.
    • Medicines to block acid in your stomach, including cimetidine
      (Tagamet®), famotidine (Pepcid®),
      nizatidine (Axid®), or ranitidine hydrochloride
      (Zantac®). Take these medicines at least 12
      hours before or at least 4 hours after you take EDURANT®.
    • Any of these medicines (if taken by mouth or injection):
      clarithromycin (Biaxin®), erythromycin (E-Mycin®,
      Eryc®, Ery-Tab®, PCE®,
      Pediazole®, Ilosone®),
      fluconazole (Diflucan®), itraconazole (Sporanox®),
      ketoconazole (Nizoral®), methadone (Dolophine®),
      posaconazole (Noxafil®), telithromycin (Ketek®),
      voriconazole (Vfend®).

This is not a complete list of medicines. Before starting EDURANT®,
be sure to tell your healthcare professional about all the medicines you
are taking or plan to take, including prescription and nonprescription
medicines, vitamins, and herbal supplements.

Before taking EDURANT®, also tell your healthcare
professional if you have had or currently have liver problems (including
hepatitis B or C), have ever had a mental health problem, are pregnant
or planning to become pregnant, or breastfeeding. It is not known if
EDURANT® will harm your unborn baby.

You and your healthcare professional will need to decide if taking
EDURANT® is right for you.

Do not breastfeed if you are taking EDURANT®. You
should not breastfeed if you have HIV because of the chance of passing
HIV to your baby.

What are the possible side effects of EDURANT®? EDURANT®
can cause serious side effects including:

  • Severe skin rash and allergic reactions. Call your doctor right away
    if you get a rash. Stop taking EDURANT® and seek
    medical help right away if you get a rash with any of the following
    symptoms: severe allergic reaction causing swelling of the face, eyes,
    lips, mouth, tongue, or throat (which may lead to difficulty
    swallowing or breathing); mouth sores or blisters on your body;
    inflamed eye (conjunctivitis); fever; dark urine; or pain on the right
    side of the stomach area (abdominal pain).
  • Depression or mood changes. Tell your doctor right away if you have
    any of the following symptoms: feeling sad or hopeless, feeling
    anxious or restless, have thoughts of hurting yourself (suicide), or
    have tried to hurt yourself.
  • Liver problems. People with a history of hepatitis B or C virus
    infection or who have certain liver function test changes may have an
    increased risk of developing new or worsening liver problems during
    treatment. Liver problems were also reported during treatment in some
    people without a history of liver disease. Your healthcare
    professional may need to do tests to check liver function before and
    during treatment.
  • Changes in body shape or body fat have been seen in some patients
    taking HIV medicines. The exact cause and long-term health effects of
    these conditions are not known.
  • Changes in your immune system (immune reconstitution syndrome).
  • Your immune system may get stronger and begin to fight infections.
    Tell your healthcare professional right away if you start having any
    new symptoms of infection.
  • Other common side effects of EDURANT® include
    depression, headache, trouble sleeping (insomnia), and rash.

This is not a complete list of all side effects. If you experience these
or other symptoms, contact your healthcare professional right away. Do
not stop taking EDURANT® or any other medications
without first talking to your healthcare professional.

You are encouraged to report side effects of prescription drugs to the
FDA. Visit,
or call 1-800-FDA-1088. You may also report side effects to Janssen
Products, LP at 1-800-JANSSEN (1-800-526-7736).

Please see full Product
for more details.

About Janssen

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are
working to create a world without disease. Transforming lives by finding
new and better ways to prevent, intercept, treat and cure disease
inspires us. We bring together the best minds and pursue the most
promising science. We are Janssen. We collaborate with the world for the
health of everyone in it. Learn more at
and follow us at @JanssenGlobal.

Cautions Concerning Forward-Looking

This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
development of potential preventive and treatment regimens for HIV. The
reader is cautioned not to rely on these forward-looking statements.
These statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially from the
expectations and projections of the Janssen Pharmaceutical Companies and
Johnson & Johnson. Risks and uncertainties include, but are not limited
to: challenges and uncertainties inherent in product development,
including uncertainty of clinical success and obtaining regulatory
approvals; uncertainty of commercial success for new indications and
therapeutic combinations; competition, including technological advances,
new products and patents attained by competitors; challenges to patents;
product efficacy or safety concerns resulting in product recalls or
regulatory action; changes in behaviour and spending patterns of
purchasers of health care products and services; changes to applicable
laws and regulations, including global health care reforms; and trends
toward health care cost containment. A further list and description of
these risks, uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the year ended January 1, 2017,
including under "Item 1A Risk Factors," its most recently filed
Quarterly Report on Form 10-Q, including in the section captioned
"Cautionary Note Regarding Forward-Looking Statements," and the
company's subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at,
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or

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