HIV Plus Magazine – Issue #106 – May-June 2015.pdf

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BECAUSE YOU’RE MORE
THAN YOUR STATUS
32 Things
You Need to
Know When
You Find Out
You Have
HIV
TREATMENTS
TESTING
STIGMA
KNOCKS OUT
FANS
& TALKS
STRAIGHT
ABOUT
BEING POZ
THE CURE
MAY / JUNE 2015
www.hivplusmag.com
ACTOR
MEL
ENGLAND
POW!
COMORBIDITIES
What is STRIBILD?
STRIBILD is a prescription medicine
used to treat HIV-1 in adults who have
never taken HIV-1 medicines before.
STRIBILD combines 4 medicines into
1 pill to be taken once a day with food.
STRIBILD is a complete single-tablet
regimen and should not be used with
other HIV-1 medicines.
STRIBILD does not cure HIV-1
infection or AIDS.
To control HIV-1
infection and decrease HIV-related
illnesses you must keep taking STRIBILD.
Ask your healthcare provider if you have
questions about how to reduce the risk of
passing HIV-1 to others. Always practice
safer sex and use condoms to lower the
chance of sexual contact with body fluids.
Never reuse or share needles or other
items that have body fluids on them.
•
Worsening of hepatitis B (HBV)
infection.
If you also have HBV and stop
taking STRIBILD, your hepatitis may
suddenly get worse. Do not stop taking
STRIBILD without first talking to your
healthcare provider, as they will need to
monitor your health. STRIBILD is not
approved for the treatment of HBV.
What should I tell my healthcare
provider before taking STRIBILD?
•
All your health problems.
Be sure to
tell your healthcare provider if you have
or had any kidney, bone, or liver problems,
including hepatitis virus infection.
•
All the medicines you take,
including
prescription and nonprescription
medicines, vitamins, and herbal
supplements. STRIBILD may affect the
way other medicines work, and other
medicines may affect how STRIBILD
works. Keep a list of all your medicines
and show it to your healthcare provider
and pharmacist. Do not start any new
medicines while taking STRIBILD
without first talking with your
healthcare provider.
•
If you take hormone-based birth
control
(pills, patches, rings, shots, etc).
•
If you take antacids.
Take antacids at
least 2 hours before or after you take
STRIBILD.
•
If you are pregnant
or plan to
become pregnant. It is not
known if STRIBILD can harm
your unborn baby. Tell your
healthcare provider if you
become pregnant while
taking STRIBILD.
•
If you are
breastfeeding
(nursing) or plan
to breast-feed.
Do not breastfeed.
HIV-1 can be
passed to the baby in
breast milk. Also, some
medicines in STRIBILD
can pass into breast milk,
and it is not known if this
can harm the baby.
Who should not take STRIBILD?
Do not take STRIBILD if you:
•
Take a medicine that contains:
alfuzosin, dihydroergotamine, ergotamine,
methylergonovine, cisapride, lovastatin,
simvastatin, pimozide, sildenafil when
used for lung problems (Revatio
®
),
triazolam, oral midazolam, rifampin
or the herb St. John’s wort.
•
For a list of brand names for these
medicines,
please see the Brief
Summary on the following pages.
•
Take any other medicines to treat
HIV-1 infection,
or the medicine
adefovir (Hepsera
®
).
IMPORTANT SAFETY
INFORMATION
What is the most important
information I should know
about STRIBILD?
STRIBILD can cause serious
side effects:
•
Build-up of an acid in your blood
(lactic acidosis),
which is a serious
medical emergency. Symptoms of
lactic acidosis include feeling very
weak or tired, unusual (not normal)
muscle pain, trouble breathing,
stomach pain with nausea or vomiting,
feeling cold especially in your arms
and legs, feeling dizzy or lightheaded,
and/or a fast or irregular heartbeat.
•
Serious liver problems.
The liver may
become large (hepatomegaly) and fatty
(steatosis). Symptoms of liver problems
include your skin or the white part of
your eyes turns yellow (jaundice), dark
“tea-colored” urine, light-colored bowel
movements (stools), loss of appetite for
several days or longer, nausea, and/or
stomach pain.
•
You may be more likely to get lactic
acidosis or serious liver problems
if
you are female, very overweight (obese),
or have been taking STRIBILD for a
long time. In some cases, these serious
conditions have led to death. Call your
healthcare provider right away if you
have any symptoms of these conditions.
What are the other possible side
effects of STRIBILD?
Serious side effects of STRIBILD
may also include:
•
New or worse kidney problems,
including kidney failure.
Your
healthcare provider should do regular
blood and urine tests to check your
kidneys before and during treatment
with STRIBILD. If you develop kidney
problems, your healthcare provider
may tell you to stop taking STRIBILD.
•
Bone problems,
including bone pain or
bones getting soft or thin, which may lead
to fractures. Your healthcare provider may
do tests to check your bones.
•
Changes in body fat
can happen in
people taking HIV-1 medicines.
•
Changes in your immune system.
Your immune system may get stronger
and begin to fight infections. Tell your
healthcare provider if you have any
new symptoms after you start taking
STRIBILD.
The most common side effects
of
STRIBILD include nausea and diarrhea.
Tell your healthcare provider if you have
any side effects that bother you or don’t
go away.
You are encouraged
to report negative side
effects of prescription
drugs to the FDA. Visit
www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Please see Brief Summary of full
Prescribing Information with
important
warnings
on the following pages.
STRIBILD is a prescription medicine used as
a complete single-tablet regimen to treat HIV-1 in
adults who have never taken HIV-1 medicines
before. STRIBILD does not cure HIV-1 or AIDS.
I started my
personal revolution
Talk to your healthcare provider
about starting treatment.
STRIBILD
is a complete HIV-1
treatment in
1 pill,
once a day.
Ask if it’s right for you.
Patient Information
STRIBILD
®
(STRY-bild)
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/
tenofovir disoproxil fumarate 300 mg) tablets
Brief summary of full Prescribing Information. For more information,
please see the full Prescribing Information, including Patient Information.
What is STRIBILD?
• STRIBILD is a prescription medicine
used to treat HIV-1 in adults
who have never taken HIV-1 medicines before. STRIBILD can also be
used to replace current HIV-1 medicines for some adults who have an
undetectable viral load (less than 50 copies/mL of virus in their blood),
and have been on the same HIV-1 medicines for at least 6 months
and have never failed past HIV-1 treatment, and whose healthcare
provider determines that they meet certain other requirements.
• STRIBILD is a complete HIV-1 medicine
and should not be used
with any other HIV-1 medicines.
• STRIBILD does not cure HIV-1 or AIDS.
You must stay on
continuous HIV-1 therapy to control HIV-1 infection and decrease
HIV-related illnesses.
• Ask your healthcare provider about how to prevent passing
HIV-1 to others.
Do not share or reuse needles, injection
equipment, or personal items that can have blood or body uids
on them. Do not have sex without protection. Always practice safer
sex by using a latex or polyurethane condom to lower the chance
of sexual contact with semen, vaginal secretions, or blood.
What is the most important information I should know
about STRIBILD?
STRIBILD can cause serious side effects, including:
1. Build-up of lactic acid in your blood (lactic acidosis).
Lactic
acidosis can happen in some people who take STRIBILD or similar
(nucleoside analogs) medicines. Lactic acidosis is a serious
medical emergency that can lead to death. Lactic acidosis can
be hard to identify early, because the symptoms could seem
like symptoms of other health problems.
Call your healthcare
provider right away if you get any of the following symptoms
which could be signs of lactic acidosis:
•
feel very weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have stomach pain with nausea or vomiting
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a fast or irregular heartbeat
2. Severe liver problems.
Severe liver problems can happen in
people who take STRIBILD. In some cases, these liver problems
can lead to death. Your liver may become large (hepatomegaly) and
you may develop fat in your liver (steatosis).
Call your healthcare
provider right away if you get any of the following symptoms
of liver problems:
• your skin or the white part of your eyes turns yellow (jaundice)
• dark “tea-colored” urine
• light-colored bowel movements (stools)
• loss of appetite for several days or longer
• nausea
• stomach pain
You may be more likely to get lactic acidosis or severe liver
problems if you are female, very overweight (obese), or have
been taking STRIBILD for a long time.
3. Worsening of Hepatitis B infection.
If you have hepatitis B virus
(HBV) infection and take STRIBILD, your HBV may get worse
( are-up) if you stop taking STRIBILD. A “ are-up” is when your
HBV infection suddenly returns in a worse way than before.
• Do not run out of STRIBILD. Re ll your prescription or talk to
your healthcare provider before your STRIBILD is all gone
• Do not stop taking STRIBILD without rst talking to your
healthcare provider
• If you stop taking STRIBILD, your healthcare provider will need to check
your health often and do blood tests regularly for several months to
check your HBV infection. Tell your healthcare provider about any new
or unusual symptoms you may have after you stop taking STRIBILD
Who should not take STRIBILD?
Do not take STRIBILD if you also take a medicine that contains:
• adefovir (Hepsera
®
)
• alfuzosin hydrochloride (Uroxatral
®
)
• cisapride (Propulsid
®
, Propulsid Quicksolv
®
)
• ergot-containing medicines, including: dihydroergotamine
mesylate (D.H.E. 45
®
, Migranal
®
), ergotamine tartrate (Cafergot
®
,
Migergot
®
, Ergostat
®
, Medihaler Ergotamine
®
, Wigraine
®
,
Wigrettes
®
), and methylergonovine maleate (Ergotrate
®
, Methergine
®
)
• lovastatin (Advicor
®
, Altoprev
®
, Mevacor
®
)
• midazolam, when taken by mouth
• pimozide (Orap
®
)
• rifampin (Rifadin
®
, Rifamate
®
, Rifater
®
, Rimactane
®
)
• sildena l (Revatio
®
), when used for treating lung problems
• simvastatin (Simcor
®
, Vytorin
®
, Zocor
®
)
• triazolam (Halcion
®
)
• the herb St. John’s wort
Do not take STRIBILD if you also take any other HIV-1
medicines, including:
• Other medicines that contain elvitegravir, cobicistat, emtricitabine,
or tenofovir (Atripla
®
, Complera
®
, Emtriva
®
, Truvada
®
, Tybost
®
,
Viread
®
, Vitekta
®
)
• Other medicines that contain lamivudine or ritonavir (Combivir
®
, Epivir
®
or Epivir-HBV
®
, Epzicom
®
, Kaletra
®
, Norvir
®
, Triumeq
®
, Trizivir
®
)
STRIBILD is not for use in people who are less than 18 years old.
What are the possible side effects of STRIBILD?
STRIBILD may cause the following serious side effects:
• See “What is the most important information I should know
about STRIBILD?”
• New or worse kidney problems, including kidney failure.
Your
healthcare provider should do blood and urine tests to check your
kidneys before you start and while you are taking STRIBILD. Your
healthcare provider may tell you to stop taking STRIBILD if you
develop new or worse kidney problems.
• Bone problems
can happen in some people who take STRIBILD.
Bone problems include bone pain, softening or thinning (which may
lead to fractures). Your healthcare provider may need to do tests to
check your bones.
•
Changes in body fat
can happen in people who take HIV-1
medicine. These changes may include increased amount of fat
in the upper back and neck (“buffalo hump”), breast, and around
the middle of your body (trunk). Loss of fat from the legs, arms
and face may also happen. The exact cause and long-term health
effects of these conditions are not known.
•
Changes in your immune system
(Immune Reconstitution Syndrome)
can happen when you start taking HIV-1 medicines. Your immune system
may get stronger and begin to ght infections that have been hidden in
your body for a long time. Tell your healthcare provider right away if you
start having any new symptoms after starting your HIV-1 medicine.
The most common side effects of STRIBILD include:
• Nausea
• Diarrhea
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away.
• These are not all the possible side effects of STRIBILD. For more
information, ask your healthcare provider.
• Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
What should I tell my healthcare provider before taking STRIBILD?
Tell your healthcare provider about all your medical conditions,
including:
•
If you have or had any kidney, bone, or liver problems, including
hepatitis B infection
•
If you are pregnant or plan to become pregnant. It is not known if
STRIBILD can harm your unborn baby. Tell your healthcare provider
if you become pregnant while taking STRIBILD.
- There is a pregnancy registry for women who take antiviral
medicines during pregnancy. The purpose of this registry is to collect
information about the health of you and your baby. Talk with your
healthcare provider about how you can take part in this registry.
• If you are breastfeeding (nursing) or plan to breastfeed. Do not
breastfeed if you take STRIBILD.
- You should not breastfeed if you have HIV-1 because of the risk
of passing HIV-1 to your baby.
- Two of the medicines in STRIBILD can pass to your baby in your
breast milk. It is not known if the other medicines in STRIBILD can
pass into your breast milk.
- Talk with your healthcare provider about the best way to feed
your baby.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements:
•
STRIBILD may affect the way other medicines work, and other
medicines may affect how STRIBILD works.
• Be sure to tell your healthcare provider if you take any of the
following medicines:
- Hormone-based birth control (pills, patches, rings, shots, etc)
- Antacid medicines that contain aluminum, magnesium hydroxide,
or calcium carbonate. Take antacids at least 2 hours before or
after you take STRIBILD
- Medicines to treat depression, organ transplant rejection, or high
blood pressure
- amiodarone (Cordarone
®
, Pacerone
®
)
- atorvastatin (Lipitor
®
, Caduet
®
)
- bepridil hydrochloride (Vascor
®
, Bepadin
®
)
- bosentan (Tracleer
®
)
- buspirone
- carbamazepine (Carbatrol
®
, Epitol
®
, Equetro
®
, Tegretol
®
)
- clarithromycin (Biaxin
®
, Prevpac
®
)
- clonazepam (Klonopin
®
)
- clorazepate (Gen-xene
®
, Tranxene
®
)
- colchicine (Colcrys
®
)
- medicines that contain dexamethasone
- diazepam (Valium
®
)
- digoxin (Lanoxin
®
)
- disopyramide (Norpace
®
)
- estazolam
- ethosuximide (Zarontin
®
)
- ecainide (Tambocor
®
)
- urazepam
- uticasone (Flovent
®
, Flonase
®
, Flovent Diskus
®
,
Flovent HFA
®
, Veramyst
®
)
- itraconazole (Sporanox
®
)
- ketoconazole (Nizoral
®
)
- lidocaine (Xylocaine
®
)
- mexiletine
- oxcarbazepine (Trileptal
®
)
- perphenazine
- phenobarbital (Luminal
®
)
- phenytoin (Dilantin
®
, Phenytek
®
)
- propafenone (Rythmol
®
)
- quinidine (Neudexta
®
)
- rifabutin (Mycobutin
®
)
- rifapentine (Priftin
®
)
- risperidone (Risperdal
®
, Risperdal Consta
®
)
- salmeterol (Serevent
®
) or salmeterol when taken in combination
with uticasone (Advair Diskus
®
, Advair HFA
®
)
- sildena l (Viagra
®
), tadala l (Cialis
®
) or vardena l (Levitra
®
,
Staxyn
®
), for the treatment of erectile dysfunction (ED). If you get
dizzy or faint (low blood pressure), have vision changes or have
an erection that last longer than 4 hours, call your healthcare
provider or get medical help right away.
- tadala l (Adcirca
®
), for the treatment of pulmonary arterial
hypertension
- thioridazine
- voriconazole (Vfend
®
)
- warfarin (Coumadin
®
, Jantoven
®
)
- zolpidem (Ambien
®
, Edlular
®
, Intermezzo
®
, Zolpimist
®
)
Know the medicines you take.
Keep a list of all your medicines and
show it to your healthcare provider and pharmacist when you get a
new medicine. Do not start any new medicines while you are taking
STRIBILD without rst talking with your healthcare provider.
Keep STRIBILD and all medicines out of reach of children.
This Brief Summary summarizes the most important information
about STRIBILD. If you would like more information, talk with your
healthcare provider. You can also ask your healthcare provider or
pharmacist for information about STRIBILD that is written for health
professionals, or call 1-800-445-3235 or go to www.STRIBILD.com.
Issued: December 2014
COMPLERA, EMTRIVA, GILEAD, the GILEAD 7Logo, GSI, HEPSERA, STRIBILD, the STRIBILD Logo,
TRUVADA, TYBOST, VIREAD, and VITEKTA are trademarks of Gilead Sciences, Inc., or its related
companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks
referenced herein are the property of their respective owners.
© 2015 Gilead Sciences, Inc. All rights reserved. STBC0171 03/15

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