Hepatitis C Drug Guide: Positively Aware
Hepatitis C Drug Guide: Positively Aware
Hepatitis C Drug Guide: Positively Aware
2 5
Y E A R S
POSITIVELY AWARE
J U LY+AU G U S T 2 0 1 4
HEPATITIS C
DRUG GUIDE
What is STRIBILD?
STRIBILD is a prescription medicine
used to treat HIV-1 in adults who
have never taken HIV-1 medicines
before. It combines 4 medicines into
1 pill to be taken once a day with
food. STRIBILD is a complete singletablet 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.
IMPORTANT SAFETY
INFORMATION
What is the most important
information I should know
about STRIBILD?
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 its 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 is a complete
regimen and should not be used with 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 fluids
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
(flare-up) if you stop taking STRIBILD. A flare-up is when your
HBV infection suddenly returns in a worse way than before.
Do not run out of STRIBILD. Refill your prescription or talk to
your healthcare provider before your STRIBILD is all gone
- digoxin (Lanoxin)
- disopyramide (Norpace)
- estazolam
- ethosuximide (Zarontin)
- flecainide (Tambocor)
- flurazepam
- fluticasone (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 fluticasone (Advair Diskus, Advair HFA)
- sildenafil (Viagra), tadalafil (Cialis) or vardenafil (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.
- tadalafil (Adcirca), for the treatment of pulmonary arterial
hypertension
- telithromycin (Ketek)
- 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 first 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: October 2013
COMPLERA, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, STRIBILD, the STRIBILD Logo,
TRUVADA, and VIREAD 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.
2014 Gilead Sciences, Inc. All rights reserved. STBC0076 03/14
COMMEMORATING
25 YEARS
POSITIVELY AWARE
JOURNALISM. INTEGRITY. HOPE.
Jeff Berry
ED ITO R- I N - C H I EF
Enid Vzquez
A S SO C IATE ED ITO R
Rick Guasco
C R E ATIV E D I R EC TO R
Jason Lancaster
P RO O FR E A D ER
CO NTR I B U TI N G W R ITER S
Laura Jones
Carlos A. Perez
Jim Pickett
Andrew Reynolds
Matt Sharp
PH OTO G R A P H ER
Chris Knight
A DV ERTI S I N G
Lorraine Hayes
L.Hayes@tpan.com
S U B SC R I PTI O N S
distribution@tpan.com
PUBLISHED BY
Whether youre positive or negative, we are all affected by HIV. Take your
best shot against HIV by taking part in A Day with HIV, POSITIVELY AWAREs
awareness and anti-stigma campaign. On September 9, use your smartphone
or digital camera and take a snapshot of an everyday moment of your life,
then upload it along with a cpation to adaywithhiv.com or email them to
photo@adaywithhiv.com. Select photos will appear in a special section of
the November+December issue of POSITIVELY AWARE.
#adaywithhiv
adaywithhiv.com
VO LU M E 2 6 N U M B E R 5
DEPARTMENTS
O N LY O N
P O S I T I V E LYAWA R E . C O M
IN BOX
25 years of being
READERS POLL
BY ENID VZQUEZ
EDITORS NOTE
F E AT U R E S
15
BY ENID VZQUEZ
Young, transgender,
and homeless
BY RICK GUASCO
BRIEFLY
19
POSITIVELY AWARE
BY ENID VZQUEZ
SPECIAL SECTION
26
29
31
36
37
38
52
C O M M E M O R AT I N G
25
Y E A R S
POSITIVELY AWARE
J U LY+AU G U S T 2 0 1 4 P O S I T I V E LY AWA R E
I N B OX
HEART AND SOUL
READERS POLL
SOUTHERN EXPOSURE
60%
YES
TWEETING THANKS
@ROBNDA216
@BLACKAIDS
40%
NO
25 years of stories.
Share yours with us.
As POSITIVELY AWARE commemorates 25 years of HIV reporting,
we want to hear from you about how the magazine has affected your life.
Well share your stories as part of PAs celebration.
surveymonkey.com/s/PVPCY33
2014. POSITIVELY AWARE (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network
(TPAN), 5050 N. Broadway St., Suite 300, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation,
providing information and support to anyone concerned with HIV and AIDS issues. POSITIVELY AWARE is
a registered trademark of TPAN. All rights reserved. Circulation: 100,000. For reprint permission, send email to
inbox@tpan.com. Six issues mailed bulk rate for $30 donation; mailed free to those living with HIV or those unable
to contribute.
We accept submission of articles covering medical or personal aspects of HIV/AIDS, and reserve the right to
edit or decline submitted articles. When published, the articles become the property of TPAN, POSITIVELY
AWARE, and its assigns. You may use your actual name or a pseudonym for publication, but please include your
name and phone number. Please include your name and phone number with your submission.
Although POSITIVELY AWARE takes great care to ensure the accuracy of all the information that it presents,
POSITIVELY AWARE staff and volunteers, TPAN, or the institutions and personnel who provide us with
information cannot be held responsible for any damages, direct or consequential, that arise from use of this material
or due to errors contained herein. Opinions expressed in POSITIVELY AWAREE are not necessarily those
of staff or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising
in POSITIVELY AWARE do not constitute endorsement or recommendation of any medical treatment or
product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a
licensed and fully HIV-informed medical practitioner, preferably a personal physician.A model, photographer, or
authors HIV status should not be assumed based on their appearance in POSITIVELY AWARE, association
with TPAN, or contributions to this journal.
P O S I T I V E LY AWA R E J U LY+AU G U S T 2 0 1 4
https://a.pgtb.me/ffPCjX
E D I TO R S N OT E
JEFF BERRY
Im cured!
This was the news I just received from a friend of
mine who underwent a somewhat grueling therapy for
hepatitis C over the past year. Two simple words, in the
form of a text message, filled with hope and excitement
for a life free from HCV.
Im thrilled to hear the news for my friend, as well
as for another who underwent a much simpler, all-oral
therapy as part of a study last year, and is now considered HCV-free. Sustained virologic response (SVR) is the
correct term, which basically means that during the six
months after you complete treatment, there is no detectable hepatitis C virus in your blood.
I look forward to one day when well be able to communicate those two simple words to each other about
HIV. Until that day, there have been some amazing
advances in HCV treatment, with many more on the way.
This is our second annual POSITIVELY AWARE HCV
Drug Guide, and this year its a collaboration between
Project Inform and Test Positive Aware Network. Here
youll read about all the FDA-approved drugs used to
treat HCV and those expected to be approved in the
coming year, plus dosing information, potential side
effects, drug interactions, and guidelines for testing and
treatment. Special thanks to Andrew Reynolds of Project
Inform, who researched and compiled the information
contained in this guide.
As I was reading the issue and reviewing the guidelines for testing, I was reminded of the fact that since I
am on the tail end of the baby boomer generation its
recommended that I be tested for HCV at least once in
my lifetime. Not to mention that Im a sexually active gay
man, and HIV-positive (its also recommended for those
populations as well, boomer or not).
Even though I was aware of the guidelines I had never
gotten tested, so I arranged to have a test performed
here at the office. I was immediately impressed by the
knowledge and skill of my counselor, Antoine, whose
demeanor instantly put me at ease while he explained
the test to me and talked about risk behavior.
He had to step out for a moment, and I was suddenly
transported back to when I took my HIV test in 1989.
Here I was sitting alone again in a room, staring at a flyer
taped to the wall but not really registering what I was
reading. I wondered what I would do if the test came
back positive. How would my life change? Would I have
Not everyone
who has
HCV and
undergoes
treatment is
cured, but
with new
treatments on
the horizon
there is hope
for even these
individuals.
FOLLOW JEFF
@PAEDITOR
J U LY+AU G U S T 2 0 1 4 P O S I T I V E LY AWA R E
Briefly
DHHS updates
HIV treatment guidelines
People on HIV therapy for at least two
years who have 300 to 500 T-cells can wait
another year to have their T-cells measured,
while those with more than 500 may stop
measuring them altogether, according
to treatment guidelines updated in May
by the Department of Health and Human
Services (DHHS). The [guidelines] Panel
recommends resumption of more frequent
CD4 count monitoring in patients who
experience virologic [viral load] rebound;
who develop new HIV-associated clinical
symptoms; or who develop conditions or
initiate therapy that may lead to reduction
of CD4 cell count, the update stated.
The panel also shifted away from listing
drug combinations for first-time therapy as
preferred to simply recommended, citing
the many combinations available for treatment-nave people. Recommended regimens in turn are divided into two categories:
those for individuals regardless of baseline
viral load or T-cell count and those only for
people with less than 100,000 viral load.
Among the slew of updates: There is
now a formal discussion of the cost of
therapy and its effect on adherence; key
principles to use when switching patients
while they have undetectable viral load;
and a new table of drug options for switching in the face of adverse effects. Go to
aidsinfo.nih.gov.
n
n
@ENIDVAZQUEZPA
P O S I T I V E LY AWA R E J U LY+AU G U S T 2 0 1 4
from all quarters that add to the deep stigma to HIV and that erect barriers between
people and what they can use to support
their health. Go to myprepexperience.
blogspot.com.
Michael Lucas, creator of Lucas
Entertainment, one of the largest studios
producing gay male porn, wrote an op-ed
for Out magazine in which he called for
Weinsteins resignation. Eric Paul Leue,
who was named Mr. Los Angeles Leather
this year, has created a petition calling for
Weinsteins resignation. Go to change.org/
petitions/ahf-remove-weinstein#.
Hepatitis C among
African Americans
The National Black Leadership Commission
on AIDS, Inc. (NBLCA) has a new campaign
to raise awareness about the effects of
hepatitis C among black people. Blacks
are twice as likely to have ever been
infected with the hepatitis C virus, NBLCA
reported in a press release. Death related
to the hepatitis C virus is almost double
the rate for black Americans compared
with non-Hispanic white Americans. Last
year, NBLCA, in conjunction with the Harm
Reduction Coalition and the Coalition on
Positive Health Empowerment (C.O.P.E.),
created the National African American
Hepatitis C Action Day, July 25, to promote
education, testing, and treatment. Go to
nblca.org.
ENID VZQUEZ
SUBSCRIBE TO PA WEEKLY
POSITIVELYAWARE.COM/SUBSCRIBE
The CDCs Act Against AIDS initiative has launched a new video and print campaign for
gay and bisexual men: Start Talking. Stop HIV. The campaign encourages men to talk
openly about HIV, their status, and testing as well as discuss medications that prevent and
treat HIV. Go to cdc.gov/actagainstaids/campaigns/starttalking for more information.
POSITIVELY AWARE
POSITIVELY AWARE
POSITIVELY AWARE
POSITIVELY AWARE
POSITIVELY AWARE
T
PHOTO: ENID VZQUEZ
IMOTHY RAY BROWN, the first person in the world cured of HIV,
could have stayed anonymous. Instead, he went from being the
Berlin patient without a name or a face to being a symbol of
hope for a cure.
J U LY+AU G U S T 2 0 1 4 P O S I T I V E LY AWA R E
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16
P O S I T I V E LY AWA R E J U LY+AU G U S T 2 0 1 4
CURED
I stopped taking HIV medication the day
of my transplant and I havent taken any
since, Brown told his audience at TPAN.
Its pretty amazing. So I am cured and I
want everybody else to be cured as well.
Asked how he feels to be HIV-negative,
he said, Its a very wonderful feeling. Its
nice not to have to take medication every
day and not have to think about it every day
except for my promotion of the cure. I am
very lucky. In 2012, he created the Timothy
Ray Brown Foundation to advocate for
research and awareness of an HIV cure.
Asked how he identifies now, he said, I
basically say Im negative, but I have very
strong ties to the HIV community. Most of
my friends have HIV and my [new] boyfriend has had HIV for 20 years. I feel very
connected to people who are HIV-positive.
While HIV could not be found in his
body, the leukemia came back a year later
and Brown needed another transplant.
The question was, will the donor agree to
give cells for a second time? Fortunately,
he did, said Brown.
J U LY+AU G U S T 2 0 1 4 P O S I T I V E LY AWA R E
17
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I got into traveling because I wanted to be somewhere else and be someone else.
down to see if I could do it. When I couldnt
stay in one place anymore, I would just
move on.
Adam has made his way from Florida,
up the East Coast and to California, hitting
most states in between.
New Orleans was the best experience,
Adam says. Its a hub where many travel
kids end up. You and your friends will
always meet up in New Orleans. As hard
and as bad as New Orleans can be, you
can always find food there. Theres a dropin shelter thats open five days a week.
Portland, Oregon and Oakland, California
are also good places for similar reasons.
While travelers usually maintain a low
profile, they sometimes attract unwanted
attention from people who disapprove of
their lifestyleand from law enforcement.
The South was the worst, Adam
says. People will be nice to you until they
discover you are any kind of different from
them. Once they see you are not like them,
they will be terrible to you. Law enforcement in the South makes it difficult for
us. Mobile, Alabama was one of the most
difficult places Ive ever been to. Every day,
the same police officers would come up to
my friends and me to harass us. Whether
we were sitting in a park or walking down
a street, theyd approach us, pat us down,
and scan our IDs even though they knew
who we were. Theyd try to get a rise out
of us just so that if we slipped up, they
could arrest us.
Travelers who are gay can also face stigma from within despite the communitys
general inclusive nature.
Being gay complicates being a traveler
because you dont know whos going to
be okay with that, says Adam. There are
some people in the traveler community
who are homophobic. When I was hitchhiking, Id never disclose my sexual orientation
to anyone, whether it was someone I was
traveling with or someone giving me a ride.
I was pretty good at playing straight.
ROADSIDE ASSISTANCE
Travelers limit their interaction with
outsiders even when they need help. The
J U LY+AU G U S T 2 0 1 4 P O S I T I V E LY AWA R E
21
Just the
one
for me
COMPLERA is a complete
HIV-1 treatment in only
1 pill a day.
Ask your healthcare
provider if COMPLERA
may be the one for you.
What is COMPLERA?
You may be more likely to get lactic acidosis or severe liver problems
if you are female, very overweight (obese), or have been taking
COMPLERA for a long time.
Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV)
infection and take COMPLERA, your HBV may get worse (flare-up) if
you stop taking COMPLERA. A flare-up is when your HBV infection
suddenly returns in a worse way than before. COMPLERA is not approved
for the treatment of HBV, so you must discuss your HBV with your
healthcare provider.
Do not run out of COMPLERA. Refill your prescription or talk to your
healthcare provider before your COMPLERA is all gone.
Do not stop taking COMPLERA without first talking to your healthcare
provider.
If you stop taking COMPLERA, your healthcare provider will need to
check your health often and do blood tests regularly to check your
HBV infection. Tell your healthcare provider about any new or unusual
symptoms you may have after you stop taking COMPLERA.
Who should not take COMPLERA?
Do not take COMPLERA if you also take any of the following medicines:
Medicines used for seizures: carbamazepine (Carbatrol, Equetro,
Tegretol, Tegretol-XR, Teril, Epitol); oxcarbazepine (Trileptal);
phenobarbital (Luminal); phenytoin (Dilantin, Dilantin-125, Phenytek)
Medicines used for tuberculosis: rifabutin (Mycobutin); rifampin
(Rifater, Rifamate, Rimactane, Rifadin); rifapentine (Priftin)
Certain medicines used to block stomach acid called proton pump
inhibitors (PPIs): dexlansoprazole (Dexilant); esomeprazole (Nexium,
Vimovo); lansoprazole (Prevacid); omeprazole (Prilosec, Zegerid);
pantoprazole sodium (Protonix); rabeprazole (Aciphex)
Certain steroid medicines: More than 1 dose of dexamethasone or
dexamethasone sodium phosphate
Certain herbal supplements: St. Johns wort
Certain hepatitis medicines: adefovir (Hepsera), lamivudine (Epivir-HBV)
Do not take COMPLERA if you also take any other HIV-1 medicines, including:
Other medicines that contain tenofovir (ATRIPLA, STRIBILD, TRUVADA, VIREAD)
Other medicines that contain emtricitabine or lamivudine (ATRIPLA,
Combivir, EMTRIVA, Epivir, Epzicom, STRIBILD, Trizivir, TRUVADA)
rilpivirine (Edurant)
COMPLERA is not for use in people who are less than 18 years old.
What are the possible side effects of COMPLERA?
COMPLERA may cause the following serious side effects:
See What is the most important information I should know
about COMPLERA?
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 COMPLERA. If you have had kidney
problems in the past or need to take another medicine that can cause
kidney problems, your healthcare provider may need to do blood tests
to check your kidneys during your treatment with COMPLERA.
Depression or mood changes. Tell your healthcare provider 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
Change in liver enzymes. People with a history of hepatitis B or C
virus infection or who have certain liver enzyme changes may have an
increased risk of developing new or worsening liver problems during
treatment with COMPLERA. Liver problems can also happen during
treatment with COMPLERA in people without a history of liver disease.
Your healthcare provider may need to do tests to check your liver
enzymes before and during treatment with COMPLERA.
Bone problems can happen in some people who take COMPLERA. 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 taking HIV-1 medicine.
These changes may include increased amount of fat in the upper back
and neck (buffalo hump), breast, and around the main part of your
body (trunk). Loss of fat from the legs, arms and face may also happen.
The cause and long term health effect 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 fight infections that have been
hidden in your body for a long time. Tell your healthcare provider if you
start having any new symptoms after starting your HIV-1 medicine.
The most common side effects of COMPLERA include:
Trouble sleeping (insomnia), abnormal dreams, headache, dizziness,
diarrhea, nausea, rash, tiredness, depression
Additional common side effects include:
Vomiting, stomach pain or discomfort, skin discoloration (small spots
or freckles), pain
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 COMPLERA. For more
information, ask your healthcare provider.
Call your healthcare provider 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 COMPLERA?
Tell your healthcare provider about all your medical conditions, including:
If you have or had any kidney, mental health, bone, or liver problems,
including hepatitis B or C infection.
If you are pregnant or plan to become pregnant. It is not known if
COMPLERA can harm your unborn child.
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 to 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 COMPLERA.
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 COMPLERA can pass to your baby in your
breast milk. It is not known if this could harm your baby.
Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take,
including prescription and nonprescription medicines, vitamins, and
herbal supplements:
COMPLERA may affect the way other medicines work, and other
medicines may affect how COMPLERA works.
If you take certain medicines with COMPLERA, the amount of
COMPLERA in your body may be too low and it may not work to help
control your HIV-1 infection. The HIV-1 virus in your body may become
resistant to COMPLERA or other HIV-1 medicines that are like it.
Be sure to tell your healthcare provider if you take any of the following
medicines:
Antacid medicines that contain aluminum, magnesium hydroxide, or
calcium carbonate. Take antacids at least 2 hours before or at least
4 hours after you take COMPLERA.
Certain medicines to block the acid in your stomach, including
cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or
ranitidine hydrochloride (Zantac). Take the acid blocker at least
12 hours before or at least 4 hours after you take COMPLERA. Some
acid blocking medicines should never be taken with COMPLERA (see
Who should not take COMPLERA? for a list of these medicines).
Medicines that can affect how your kidneys work, including acyclovir
(Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert),
valacyclovir (Valtrex), and valganciclovir (Valcyte).
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)
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 COMPLERA
without first talking with your healthcare provider.
How should I take COMPLERA?
Stay under the care of your healthcare provider during treatment with
COMPLERA.
Take COMPLERA exactly as your healthcare provider tells you to take it.
Always take COMPLERA with food. Taking COMPLERA with food is important
to help get the right amount of medicine in your body. A protein drink is not
a substitute for food. If your healthcare provider decides to stop COMPLERA
and you are switched to new medicines to treat HIV-1 that includes
rilpivirine tablets, the rilpivirine tablets should be taken only with a meal.
Keep COMPLERA and all medicines out of reach of children.
This Brief Summary summarizes the most important information about
COMPLERA. If you would like more information, talk with your healthcare
provider. You can also ask your healthcare provider or pharmacist for
information about COMPLERA that is written for health professionals, or
call 1-800-445-3235 or go to www.COMPLERA.com.
Issued: December 2013
COMPLERA, the COMPLERA Logo, EMTRIVA, GILEAD, the GILEAD Logo, GSI,
HEPSERA, STRIBILD, TRUVADA, VIREAD, and VISTIDE 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.
2014 Gilead Sciences, Inc. All rights reserved. CPAC0098 02/14
DAWN OF A NEW
New guidelines, new treatments: Project Informs Andrew Reynolds
takes a look at the standard of care for HCV in 2014
NEW GUIDELINES
With new advances in HCV, we also have new
recommendations to guide decisions for its testing, management, and treatment. The American
Association for the Study of Liver Diseases (AASLD)
and Infectious Diseases Society of America (IDSA)
released the Recommendations for Testing,
Managing, and Treating Hepatitis C to keep medical providers up to date with the rapidly changing
HCV SCREENING:
WHO SHOULD BE TESTED?
To be perfectly candid, we have not done a very
26 P O S I T I V E LY AWA R E
J U LY+AU G U S T 2 0 1 4
ERA
C O M M E M O R AT I N G
25
Y E A R S
POSITIVELY AWARE
Additional risk
factors associated
n co-occurring
J U LY+AU G U S T 2 0 1 4
STDs
multiple sex
partners
n group sex
n use of noninjection drugs
(especially
during sex)
n
P O S I T I V E LY AWA R E
27
ANDREW
REYNOLDS is
the Hepatitis C
Education Manager
at Project Inform,
and facilitates
several HCV support
groups in the San
Francisco Bay Area.
Hes also a counselor
on the HELP-4-HEP
HCV phoneline listed in the resources
section of this
issue. Call him if you
have any questions
about HCV care and
treatment.
SPECIAL THANKS
TO MARIA LOPEZ,
PharmD, AAHIVP,
the Pharmacy
Director of Los
Portales Pharmacy
in San Francisco,
who reviewed the
Hepatitis C Drug
Guide.
28
P O S I T I V E LY AWA R E J U LY+AU G U S T 2 0 1 4
HOW TO USE
THIS GUIDE
A CHART
WITH EACH
DRUG, AND ITS
CORRESPONDING
DRUG CLASS, CAN
BE FOUND ON
PAGE 31.
DRUG CLASS
Just as HIV medications are divided into several different drug classes, the DAA (direct acting antiviral) era of HCV treatment has seen the development
of several different classes as well. Currently, there
are four classes of HCV drugs:
DRUG NAMES
n
n
NS5A inhibitors
Non-nucleoside NS5B polymerase inhibitors
29
The AWP is the measure used by insurance companiesboth private and publicto determine the
average cost of prescription drugs. HCV drugs are
very expensive, and there is much concern over
the burden these high costs are going to place on
programs like Medicaid and Medicare, as well as
the Veterans Administration and private insurance
carriers. Patients should never have to pay for medications at this price, but its still important to know
these costs when shopping for health insurance
coverage. Each of the pharmaceutical companies
has a Patient Assistance Program (PAP) to help
uninsured and underinsured people cover all or part
of the costs. There are also pharmaceutical co-pay
programs and non-profit organizations that can help
with some additional support for co-pays. We provide a list of HCV drug patient assistance and co-pay
programs on page 37.
DOSAGE
HCV drugs are taken in a variety of ways, at different times, and with differing food restrictions.
Sometimes, the same drug is taken differently
depending upon a variety of factors like genotype
or liver health. This section will describe the dosage
requirements for the drug, as well as provide details
about restrictions and other relevant information.
POTENTIAL SIDE EFFECTS AND ADVERSE EVENTS
P O S I T I V E LY AWA R E J U LY+AU G U S T 2 0 1 4
BRAND
NAME
GENERIC/
COMMON NAME
STATUS
GENOTYPE
(FDA AND
OFF-LABEL)
IFN-FREE?
APPROVED
FOR HIV/
HCV COINFECTION?
MANUFACTURER
FIND
IT ON
PAGE
Pegylated interferon
PegIntron
Peginterferon
alfa-2b
PEG; IFN
Approved
1,2,3,4,5,6
N/A
Yes
Merck
38
Pegylated interferon
Pegasys
Peginterferon
alfa-2a
PEG; IFN
Approved
1,2,3,4,5,6
N/A
Yes
Genentech
38
Nucleoside analog
Ribasphere
ribavirin
RBV
Approved
1,2,3,4,5,6
Yes, with
several other
HCV drugs
only
Yes
Kadmon
39
Nucleoside analog
Copegus
ribavirin
RBV
Approved
1,2,3,4,5,6
Yes, with
several other
HCV drugs
only
Yes
Genentech
39
Nucleoside analog
Rebetol
ribavirin
RBV
Approved
1,2,3,4,5,6
Yes, with
several other
HCV drugs
only
Yes
Merck
39
Incivek
telaprevir
TVR
Approved
No
No
Vertex
41
Victrelis
boceprevir
BOC
Approved
No
No
Merck
40
Olysio
simeprevir, SMV
Approved
No
No
Janssen
46
N/A
asunaprevir
ASV
Submitted
for approval
1b
Yes
TBD
Bristol-Myers
Squibb
49
N/A
ABT-450/r
Submitted
for approval
Yes
TBD
AbbVie
50
Sovaldi
sofosbuvir
SOF, SOV
Approved
1,2,3,4,5,6
Yes, for GT 2
and 3;
in limited
cases for GT 1
Yes
Gilead
Sciences
47
NS5A inhibitor
N/A
ledipasvir
LDV
Submitted
for approval
1
(possibly 3)
Yes
TBD
Gilead
Sciences
48
NS5A inhibitor
N/A
daclatasvir
DCV
Submitted
for approval
1,2,3,4
Yes
TBD
Bristol-Myers
Squibb
49
NS5A inhibitor
N/A
ombitasvir
(ABT-267)
Submitted
for approval
Yes
TBD
AbbVie
50
Non-nucleoside NS5B
polymerase inhibitors
N/A
dasabuvir
(ABT-333)
Submitted
for approval
Yes
TBD
AbbVie
50
Non-nucleoside NS5B
polymerase inhibitor
N/A
BMS-791325
Phase III
clinical trials
Yes
TBD
Bristol-Myers
Squibb
49
J U LY+AU G U S T 2 0 1 4 P O S I T I V E LY AWA R E
31
POSITIVELY AWARE
POSITIVELY AWARE
POSITIVELY AWARE
AASLD/IDSA recommendations
(SEE PAGE 31 FOR DRUG ABBREVIATIONS)
RECOMMENDED REGIMENS
ALTERNATIVE REGIMENS
GT 1
GT 2
None
GT 3
GT 4
GT 6
RECOMMENDED REGIMENS
ALTERNATIVE REGIMENS
GT 1
GT 2
GT 3
GT 4
GT 6
RECOMMENDATIONS FOR HCV TREATMENT IN PATIENTS WHO ARE CO-INFECTED WITH HIV/HCV
HEPATITIS C GENOTYPE
RECOMMENDED REGIMENS
ALTERNATIVE REGIMENS
GT 1, treatment-nave and
those with viral relapse after
prior PEG/RBV treatment
GT 2, regardless
of treatment history
GT 3, regardless
of treatment history
GT 4, regardless
of treatment history
None
P O S I T I V E LY AWA R E J U LY+AU G U S T 2 0 1 4
None
Hepatitis C Co-Pay
and Patient Assistance Programs (PAPs)
Like HIV, treatment for HCV is expensive, but the good news is that help is out there. Many of the pharmaceutical companies have a patient assistance program (PAP) to help uninsured and underinsured people
cover all or part of the costs of their drug. There are also pharmaceutical co-pay programs and non-profit
organizations that can help with some additional support for co-pays. Check with each program for details.
DRUG
COMPANY
CONTACT INFO
Copegus
Genentech
(888) 941-3331;
pegaysaccesssolutions.com
Incivek
Vertex Pharmaceuticals
(855) 837-8394;
incivek.com
Olysio
Janssen Pharmaceuticals
(855) 565-9746;
janssenprescriptionassistance.com/olysio-cost-assistance;
olysio.com
Pegasys
Genentech
(888) 941-3331;
pegaysaccesssolutions.com; pegasys.com
PegIntron
Merck
(866) 939-4372;
merckhelps.com; pegintron.com
Sovaldi
Gilead
(855) 769-7284;
mysupportpath.com; sovaldi.com
Victrelis
Merck
(866) 939-4372;
merckhelps.com; victrelis.com
ADDITIONAL PROGRAMS
Harbor Path
harborpath.org
Provides a single site for all patient assistance program applications for both HIV and HCV medications.
Needy Meds
needymeds.com
Provides a one-stop site for patient assistance programs and other discount opportunities for a variety
of pharmaceuticals; also has a very useful database
to find free and low-cost medical clinics.
www.copays.org/diseases/hepatitis-c
J U LY+AU G U S T 2 0 1 4 P O S I T I V E LY AWA R E
37
PegIntron; Pegasys
COMMON NAMES:
Interferon (interferon
alfa-2a, interferon
alfa-2b)
GENOTYPE: 1, 2, 3, 4, 5, 6
Approved for
HIV/HCV co-infection.
DOSAGE:
Interferon has a large number of side effects associated with it: fatigue, headaches, nausea, chills,
insomnia, anemia, pyrexia (fever), injection site
reactions, loss of appetite, rash, myalgia (muscle
pain), neutropenia, irritability, depression, alopecia
(hair loss), dyspnea (shortness of breath), arthralgia (joint pain), pruritis (itching), flu-like feelings,
dizziness, diarrhea, cough, weight loss, vomiting,
unspecified pain, dry skin, anxiety, abdominal pain,
leukopenia and thrombocytopenia. In the case of
the psychiatric/emotional side effects: interferon
has been associated with depression, anxiety and in
rare cases, suicidal thoughts. If you have a history of
any of these conditions, talk to your provider before
starting HCV treatment (it does not mean you cant
take HCV treatment, you just want to watch for signs
and be able to take preventative actions ahead of
time). As an injectable, injection site reactions (redness, swelling, and/or itching) and inflammation are
common. If you have autoimmune hepatitis, or are
allergic to any of the ingredients in interferon, you
should not take it.
MANUFACTURER:
More information
Interferon is the oldest HCV drug we have, and quite
frankly its the one most people cant wait to get rid
of. Most of the severe side effects that people experience while on HCV treatment are caused by interferon, and the fact that it is an injectable drug makes
it even less desirable to people. The DAA era will
likely make this drug obsolete, but there may still be
a role for select patients. In the meantime, interferon
is still used and recommended in many treatment
regimens for GT 1 and 4.
1.6 MILLION
DIAGNOSED (KNOW
THEIR STATUS)
1.01.2 MILLION
PegIntron: Merck;
Pegasys: Genentech
(Roche)
REFERRED TO CARE
200,000360,000
AWP:
IN TREATMENT
170,000200,000
SUCCESSFULLY
BEING TREATED
50%
38
P O S I T I V E LY AWA R E J U LY+AU G U S T 2 0 1 4
3238%
711%
56%
ribavirin, RBV
Generic available
FDA STATUS: Approved
CLASS:
Nucleoside analog
GENOTYPE: 1, 2, 3, 4, 5, 6
Approved for
HIV/HCV co-infection.
DOSAGE:
Ribavirin dosage
depends upon the
brand, and is given in
either fixed doses or in
doses related to weight
(weight-based). The
dose range is 800 mg to
1,400 mg per day taken
in two divided doses.
Must be taken with food.
Ribavirin should never
be taken by itself. Take
your missed dose as
soon as possible, unless
its too close to your
next dose. Never double
dose.
More information
Its not entirely understood how ribavirin works
against HCV, but along with interferon, its been a
major part of HCV treatment for years, and will continue to play an important role in the future. The side
effects can be challenging, even without interferon.
Consequently, just as interferon-free treatment is the
goal of the new standard of care, there is a move for
ribavirin-free ones as well.
Ribavirin (and some other HCV medications), can affect your bodys production of red blood cells, white blood
cells and platelets. Follow your medical providers directions for regular screening to check for these conditions.
Be sure to keep copies of your lab results and track them over time. NOTE: Whenever a lab test is out of range,
there is usually an indication (such as a star or other way to highlight it).
CONDITION
LAB TEST
NORMAL RANGE
SYMPTOMS
Anemia
Hemoglobin
Male: 13.5-17.5
Female: 12.0-16.0
Hematocrit
Male: 4254
Female: 3747
Neutropenia
Neutrophils
None
Leukopenia
Leukocytes
4.511.0 (x103/mm3)
Thrombocytopenia
Platelets
150399 (x103/mm3)
Genentech (Copegus);
Merck (Rebetol);
Kadmon (Ribasphere)
MANUFACTURER:
AWP:
J U LY+AU G U S T 2 0 1 4
P O S I T I V E LY AWA R E
39
Victrelis
COMMON NAMES:
boceprevir, BOC
NS3/4A protease
inhibitor
GENOTYPE: 1
Merck
with St. Johns wort. Do not take with Sustiva (efavirenz) and avoid Kaletra (lopinavir/ritonivir), Prezista
(darunavir), and Reyataz (atazanavir). Can be taken
with nucleoside reverse transcriptase inhibitors
(including Truvada), Isentress (raltegravir), Tivicay
(dolutegravir), Edurant (rilpivirine); dose adjustments
needed if taken with Selzentry (maraviroc). Victrelis
increases the levels of erectile dysfunction drugs
(Viagra, Cialis, and Levitra), so these doses should
not exceed 10 mg Cialis or 2.5 mg of Levitra per
72 hours, or 25 mg of Viagra per 48 hours. Do not
take with rifampin, lovastatin, simvastatin, nor with
sedatives/hypnotics such as midazolam or triazolam;
can be taken with methadone and buprenorphine,
but monitoring of methadone levels and patient
discomfort is recommended as some may need a
dose increase due to reduced concentrations of
methadone.
More information
Victrelis is not likely to be used any longer due to
its limited effectiveness, high pill burden, and long
length of treatment duration. The AASLD/IDSA no
longer recommend its use. High levels of drug resistance in people who dont achieve an SVR is another
problem with this drug. Merck is developing other
HCV drugs that look more promising than Victrelis,
including some excellent early results for treating
HIV/HCV co-infected people, likely to be submitted
for approval in late 2015.
TREATMENT RECOMMENDATIONS
Treatment-naive
Undetectable
Undetectable
Treatment-naive
Detectable
Undetectable
Partial responders
or viral relapsers
Undetectable
Undetectable
Partial responders
or viral relapsers
Detectable
Undetectable
AWP:
40 P O S I T I V E LY AWA R E
If a patient has a detectable viral load of above 100 IU/mL at week 12, discontinue treatment.
If a patient has a detectable viral load of any level at week 24, discontinue treatment.
J U LY+AU G U S T 2 0 1 4
Incivek
COMMON NAME:
telaprevir, TVR
NS3/4A protease
inhibitor
GENOTYPE: 1
Vertex
AWP:
More information
Theres not a whole lot to say about this drug, as
its not going to be prescribed any longer and the
AASLD/IDSA no longer recommend its use. It was
great when it came on the scene, especially when
compared to the effectiveness of pegylated interferon
and ribavirin dual therapy for the treatment of GT 1,
but it just doesnt stand up to the new and forthcoming HCV drugs in terms of pill burden and dosing, as
well as SVR rates and side effects.
Incivek is response-guided therapy: Treatment
should be stopped if one has a detectable HCV viral
load greater than 1000 IU/mL at week 4 or 12, or a
detectable viral load of any level at week 24.
INCIVEK, PEGYLATED
INTERFERON, AND RIBAVIRIN
PEGYLATED INTERFERON
AND RIBAVIRIN
TOTAL TREATMENT
DURATION
Undetected at
weeks 4 and 12
Additional 12 weeks
24 weeks
Detectable at weeks 4
and 12 (see below)
Additional 36 weeks
48 weeks
INCIVEK, PEGYLATED
PEGYLATED INTERFERON
INTERFERON, AND RIBAVIRIN AND RIBAVIRIN
TOTAL TREATMENT
DURATION
48 weeks
Additional 36 weeks
J U LY+AU G U S T 2 0 1 4
P O S I T I V E LY AWA R E
41
ABOUT PREZISTA
PREZISTA does not cure HIV infection or AIDS and you may continue
to experience illnesses associated with HIV-1 infection, including
opportunistic infections. You should remain under the care
of a doctor when using PREZISTA.
Please read Important Safety Information below, and talk to your
healthcare provider to learn if PREZISTA is right for you.
Before taking PREZISTA, tell your healthcare provider if you are taking
sildenafil (Viagra, Revatio), vardenafil (Levitra, Staxyn), tadalafil
(Cialis, Adcirca), atorvastatin (Lipitor), rosuvastatin (Crestor),
pravastatin (Pravachol), or colchicine (Colcrys, Col-Probenecid). Tell
your healthcare provider if you are taking estrogen-based contraceptives
(birth control). PREZISTA might reduce the effectiveness of estrogenbased contraceptives. You must take additional precautions for birth
control, such as condoms
Serious problems can happen if you or your child takes any of these
medicines with PREZISTA.
This is not a complete list of medicines. Be sure to tell your
healthcare provider about all the medicines you are taking or plan
to take, including prescription and nonprescription medicines,
vitamins, and herbal supplements. Do not start any new medicines
while you are taking PREZISTA without first talking to your
healthcare provider.
What should I tell my doctor before I take PREZISTA?
Before taking PREZISTA, tell your healthcare provider if you have
any medical conditions, including liver problems (including hepatitis B
or C), allergy to sulfa medicines, diabetes, or hemophilia
Tell your healthcare provider if you are pregnant or planning to become
pregnant, or are breastfeeding
The effects of PREZISTA on pregnant women or their unborn babies
are not known. You and your healthcare provider will need to decide
if taking PREZISTA is right for you
Do not breastfeed. It is not known if PREZISTA can be passed
to your baby in your breast milk and whether it could harm your baby.
Also, mothers with HIV should not breastfeed because HIV can
be passed to your baby in the breast milk
What are the possible side effects of PREZISTA?
High blood sugar, diabetes or worsening of diabetes, and increased
bleeding in people with hemophilia have been reported in patients taking
protease inhibitor medicines, including PREZISTA
Changes in body fat have been seen in some patients taking HIV
medicines, including PREZISTA. The cause and long-term health effects
of these conditions are not known at this time
Changes in your immune system can happen when you start taking HIV
medicines. Your immune system may get stronger and begin to fight
infections that have been hidden
The most common side effects related to taking PREZISTA include
diarrhea, nausea, rash, headache, stomach pain, and vomiting.
This is not a complete list of all possible side effects. If you experience
these or other side effects, talk to your healthcare provider. Do not stop
taking PREZISTA or any other medicines without first talking to your
healthcare provider
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 refer to the ritonavir (Norvir) Product Information (PI and PPI)
for additional information on precautionary measures.
Please see accompanying full Product Information
for more details.
013729-140415
ily
Once-Da
Call
**PRZ (**779)
Janssen Therapeutics,
Division of Janssen Products, LP
Janssen Therapeutics, Division of Janssen Products, LP 2014
05/14 014606-140430
Olysio
COMMON NAMES:
simeprevir, SMV
NS3/4A protease
inhibitor
GENOTYPE: 1
inhibitors (PIs), the non-nucleoside reverse transcriptase inhibitors (NNRTIs) Sustiva (efavirenz, also in
Atripla) or Viramune (nevirapine) or Intelence (etravarine), or with cobicistat-boosted regimens (Stribild).
Olysio can be taken with Edurant (rilpivirine),
Isentress (raltegravir), Tivicay (dolutegravir), and the
nucleoside reverse transcriptase inhibitors including
Truvada, Ziagen (abacavir), Emtriva (emtricitabine),
Epivir (lamivudine), Epzicom, and Viread (tenofovir).
Olysio boosts the levels of erectile dysfunction drugs
(Viagra, Cialis, and Levitra). Start with the lowest
dose possible and increase as needed. Do not use
with the herbs milk thistle (silymarin) or St. Johns
wort. Anticonvulsants such as phenobarbital, carbamazepine, phenytoin, and oxcarbazepine should not
be used as they reduce the concentrations of Olysio,
thus reducing its effectiveness. Rifampin, rifabutin,
and rifapentine should not be taken. Antibiotics erythromycin, clarithromycin, and telithromycin increase
levels of Olysio so they should be avoided, as should
the antifungals fluconazole, voriconazole, itraconazole,
ketoconazole, and posaconazole. Antiarrhythmics such
as Tambocor and Cordarone should not be taken; no
interactions with methadone and buprenorphine.
More information
GT 1 can be treated with Sovaldi and Olysio with or
without ribavirin in what is called off-label (not FDAapproved) use based on the results of the COSMOS
study, which saw high SVR (cure) rates and minimal
side effects for both treatment-nave and prior nonresponders. For individuals who need treatment now,
but cannot tolerate interferon, this is an excellent
option. In May 2014, Janssen submitted this combination for FDA approval.
Janssen Therapeutics
TWO IMPORTANT COMPONENTS OF OLYSIO TREATMENT
AWP:
1. People with genotype 1a need a blood test called a Q80K polymorphism, for a resistant strain of HCV.
This polymorphism reduces treatment effectiveness and other medications should be considered.
2. Olysio is response-guided therapy: Treatment should be stopped if one has a detectable HCV viral load
of any level at weeks 4, 12, or 24.
46
OLYSIO, PEGYLATED
INTERFERON AND
RIBAVIRIN
PEGYLATED INTERFERON
AND RIBAVIRIN
TOTAL TREATMENT
DURATION
Additional 12 weeks
24 weeks
Additional 36 weeks
48 weeks
P O S I T I V E LY AWA R E J U LY+AU G U S T 2 0 1 4
Sovaldi
COMMON NAMES:
Approved for
HIV/HCV co-infection.
DOSAGE:
More information
TREATMENT
DURATION OF TREATMENT
Genotype 1 and 4
12 weeks
Genotype 2
Sovaldi + ribavirin
12 weeks
Genotype 3
Sovaldi + ribavirin
24 weeks
J U LY+AU G U S T 2 0 1 4
P O S I T I V E LY AWA R E
47
ledipasvir/sofosbuvir, LDV/SOF
FDA STATUS:
CLASS:
ledipasvir: NS5A
inhibitor; sofosbuvir:
Nucleotide analog NS5B
polymerase inhibitor
GENOTYPE: 1 (possibly 3)
Being studied in
HIV/HCV co-infection;
has shown promising
results in clinical studies
DOSAGE:
Still investigational.
A fixed dose combination
(FDC) of ledipasvir 90
mg/sofosbuvir 400 mg.
Take one tablet once daily
with or without food; may
or may not be taken in
combination with ribavirin (see chart for more
details). Take your missed
dose as soon as possible,
unless it is closer to the
time of your next dose.
Never double your dose.
Duration of therapy not
yet determined, but the
submission for approval
to the FDA was based on
the following clinical trial
data, which gives a sense
of what the final approval
will look like. The chart
summarizes the various
treatment regimens for
these studies.
More information
This combination may be a real game-changer for
treating HCV GT 1: One pill, once daily potentially
curing HCV in eight weeks is an astounding achievement. It is also worth noting that the combination
of sofosbuvir with another NS5A inhibitor, BMS
daclatasvir, also cures people at very high rates with
minimal side effects. We will get a better sense of
its indications and dosing once it gets FDA approval,
but in addition to treating GT 1, this combination has
shown very promising results for people with the
more difficult to treat GT 3, as well as in HIV/HCV
co-infected individuals. Sofosbuvir alone is already
approved, as Sovaldi.
PATIENT GROUP
TREATMENT
DURATION
SVR 12
ION-1
GT 1 treatment-nave
(including 15.7% with cirrhosis)
SOF/LDV
SOF/LDV + RBV
SOF/LDV
SOF/LDV + RBV
12 weeks
12 weeks
24 weeks
24 weeks
97.7%
97.2%
N/A
N/A
ION-2
GT 1 treatment-experienced
(including 20% with cirrhosis)
SOF/LDV
SOF/LDV + RBV
SOF/LDV
SOF/LDV + RBV
12 weeks
12 weeks
24 weeks
24 weeks
93.6%
96.4%
99.1%
99.1%
ION-3
GT 1 treatment-nave, no cirrhosis
SOF/LDV
SOF/LDV + RBV
SOF/LDV
8 weeks
8 weeks
12 weeks
94%
93.1%
95.4%
MANUFACTURER:
Gilead Sciences
48 P O S I T I V E LY AWA R E
J U LY+AU G U S T 2 0 1 4
COMMON NAMES:
daclatasvir and
asunaprevir: Submitted
for approval; ruling
expected Fall 2014
BMS-791325: Not yet
submitted for approval
CLASS:
Being studied in
HIV/HCV co-infection;
under study for use with
sofosbuvir
DOSAGE:
Still investigational.
Take one daclatasvir
60 mg tablet once daily;
take one asunaprevir
100 mg softgel capsule
twice daily; take one
75 mg or 150 mg BMS791325 tablet twice daily.
When taken with Sovaldi
(sofosbuvir) take one
daclatasvir 60 mg tablet
once per day and one
Sovaldi 400 mg orally
with or without weightbased ribavirin, taken
twice daily. Take your
missed dose as soon as
possible, unless its too
close to your next dose.
Never double dose.
including asunaprevir, BMS-791325, Sovaldi (sofosbuvir), and MK-5172 (NS3/4A PI from Merck). Limited
data has shown that there are no dose adjustments
necessary with some HIV medications. There are no
available data on drug interactions between asunaprevir and other drugs at the time of writing as the
studies are ongoing, but as it is a protease inhibitor,
it is likely to interact with the HIV PIs as well, but be
suitable for use with the NRTIs, rilpivirine, integrase
inhibitors, and maraviroc. There are no available data
on the interactions of BMS-791325, but studies are
underway.
More information
Before Gilead bought sofosbuvir (Sovaldi) from
Pharmasset and decided to pursue the combination
of ledipasvir/sofosbuvir, the combination of daclatasvir/sofosbuvir had generated quite a buzz in the HCV
community due to its high level of cure rates. Gilead
suspended working with BMS, much to the criticism,
from many advocates and people with HCV, but the
potential for this combination remains high. The
combination of daclatasvir/sofosbuvir has shown
excellent treatment response rates in this population,
but also in the more difficult to treat GT 3 patients.
It remains to be seen if the FDA will approve this
use, or if clinicians will have to use them off-label.
Similarly, the daclatasvir/asunaprevir combination
has been shown to be effective against GT 1b, which
is the most common strain of HCV world-wide.
Daclatasvir is also being investigated for its use in
HIV/HCV co-infected people.
DRUG REGIMEN
GENOTYPE
NUMBER OF
PARTICIPANTS
SVR 12
AI443-014
Daclatasvir + asunaprevir
+ BMS-791325 75 mg
77
92.2% (71/77)
AI443-014
Daclatasvir + asunaprevir
+ BMS-791325 150 mg
84
91.7% (77/84)
MANUFACTURER:
Bristol-Myers Squibb
J U LY+AU G U S T 2 0 1 4
P O S I T I V E LY AWA R E
49
CLASS:
ABT-450/r: NS3/4A
protease inhibitor, boosted with ritonavir;
ombitasvir: NS5A
inhibitor
dasabuvir: Nonnucleoside NS5B
polymerase inhibitor
GENOTYPE: 1
Still investigational.
ABT 450/r (150 mg/
100 mg) is co-formulated
with ombitasvir (25 mg);
take one tablet once
daily with or without
food. Must be taken
in combination with
one 200 mg tablet of
dasabuvir, twice daily;
none should ever be
taken by itself. If ribavirin is prescribed, take a
weight-based dose, two
times daily with food.
Take your missed dose
as soon as possible,
unless its too close to
your next dose. Never
double dose.
MANUFACTURER:
AbbVie
50 P O S I T I V E LY AWA R E
More information
The results from the clinical trials of this regimen are
very promising for both GT 1a and 1b. FDA approval is
pending, but it looks like this regimen has higher SVR
(cure) rates for GT 1a when ribavirin is used. GT 1b
does not look like it will need ribavirin, which is good
news for the rest of the world as GT 1b is the most
common genotype across the globe. Research studies are underway to see how this regimen works for
people co-infected with HIV/HCV and in people with
post-liver transplants.
GENOTYPE,
PATIENT TYPE
PEARL-II
GT 1b,
treatment experienced
PEARL-II
GT 1b,
treatment naive
NUMBER
TREATMENT
SVR 12
179
ABT-450/r-ombitasvir+dasabuvir + RBV
97% (85/88)
ABT-450/r-ombitasvir+dasabuvir
100% (91/91)
419
ABT-450/r-ombitasvir+dasabuvir + RBV
99% (209/210)
ABT-450/r-ombitasvir+dasabuvir
99% (207/209)
ABT-450/r-ombitasvir+dasabuvir + RBV
97% (97/100)
PEARL-IV
GT 1a
treatment naive
305
TURQUOISE-II
12 & 24 weeks
GT 1 treatment
nave and treatment
experienced with
compensated cirrhosis
380
ABT-450/r-ombitasvir+dasabuvir
90% (185/205)
ABT-450/r-ombitasvir+dasabuvir + RBV
for 12 weeks
92% (191/208)
ABT-450/r-ombitasvir+dasabuvir + RBV
for 24 weeks
96% (165/172)
SAPPHIRE-I
GT 1, treatment naive
631
ABT-450/r-ombitasvir+dasabuvir + RBV
96% (455/473)
SAPPHIRE-II
GT 1,
treatment experienced
394
ABT-450/r-ombitasvir+dasabuvir + RBV
96% (286/297)
J U LY+AU G U S T 2 0 1 4
HEPATITIS C.
WHO CAN
Help4Hep
877.435.7443
www.help4hep.org
Caring Ambassadors
877-435-7443 toll-free
hepcchallenge.org
Project Inform
projectinform.org
800-822-7422 toll-free
Staffed by trained Project Inform operators and staff,
many of whom also live with or are impacted by HIV.
Call-back service MondayFriday, 10 am4 pm PST.
AIDS/HIV Nightline
800-628-9240 toll-free
Operates 5 pm5 am and is run by the San Francisco
Suicide Prevention hotline. Very strong on offering
emotional support and health education.
Hep C Association
hepcassoc.org
natap.org
Hep C Connection
hepc-connection.org
Array of services for people throughout Colorado.
Excellent site for news and information.
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52
P O S I T I V E LY AWA R E J U LY+AU G U S T 2 0 1 4
SOURCE: CDC
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