Special Consultant at AIDS Medical Center
National Hospital Organization
Osaka National Hospital
Editorial Supervisor

What to do if you missa dose of BIKTARVY
Combination Tablets

Takuma Shirasaka

Side effects

Precautions®

Attaining U=U status

For People
Taking BIKTARVY
Combination Tablets
How to take BIKTARVY
Combination Tablets /Effects

Introduction /Table of contents

Introduction
This leaﬂet was created for people who take BIKTARVY Combination Tablets. It
includes information about the characteristics of BIKTARVY Combination Tablets,
how to take BIKTARVY Combination Tablets, what to do if you forget to take
BIKTARVY Combination Tablets, the side effects of BIKTARVY Combination
Tablets, and precautions for taking BIKTARVY Combination Tablets. Read thisleaﬂet carefully before taking BIKTARVY Combination Tablets.

The treatment of HIV (human immunodeﬁciency virus) infection is aimed at
inhibiting the multiplication of HIV, thereby preventing the onset of AIDS.
BIKTARVY Combination Tablets is one of the drugs called “anti-HIV medicines”
that suppress the multiplication of HIV.
To safely achieve the adequate efﬁcacy of an anti-HIV medicine, it is important totake it correctly.
A medical decision needs to be made based on your own particular circumstances
before starting the administration of BIKTARVY Combination Tablets.
Listen carefully to the explanation provided by your healthcare provider (doctor,
nurse, or pharmacist) and follow their instructions.

If you have any questions about the administration of BIKTARVY Combination
Tablets, consult your healthcare provider (doctor, nurse, or pharmacist).

1

7 If you are taking other medicines
8 Precautions for taking
BIKTARVY Combination Tablets
9 What should you do if you miss a doseof BIKTARVY Combination Tablets?
10 How to prevent missing a dose
1 1 Side effects of BIKTARVY Combination
Tablets
13 Attaining U=U status
Back cover Information sources concerning
HIV infection

2

Introduction /Table of contents
How to take BIKTARVY
Combination Tablets /Effects

5 For better treatment going forward

Precautions

3 What are BIKTARVY Combination
Tablets?

What to do if you missa dose of BIKTARVY
Combination Tablets

1 Introduction

Side effects

Table of contents

Attaining U=U status

For People Taking BIKTARVY
Combination Tablets

What are BIKTARVY
Combination Tablets?
BIKTARVY is a medicine for HIV infection that suppresses the multiplicationof the virus in the blood1).
When BIKTARVY Combination Tablets are administered and the multiplication of HIV in the blood is
suppressed, immune-compromised patients recover some of their immune function and are less likely toacquire opportunistic infections2).
Note 1)

Herpesvirus
infection

Amount of virus in the blood

The amount of virus in the blood is represented by the viral count in 1 mLof plasma. It indicates the treatment start time and/or the effects of theanti-HIV medicines. The goal of treatment is to maintain a viralconcentration that is below the detection limit over a long period of time.
Note 2)

Opportunistic infections

Signiﬁes infections caused by weakly pathogenic microorganisms that do
not cause infections in people with normal immune function.
Opportunistic infections include candida esophagitis, herpesvirus
infection, and Mycobacterium avium complex (MAC) infection.

Candidaesophagitis

Mycobacterium
avium
complex (MAC)
infection

How to take BIKTARVY Combination Tablets
Take one tablet of BIKTARVY once a day, with or without food.
To avoid forgetting to take BIKTARVY, and to ensure that it is taken at a regular interval, consult yourdoctor and decide the time of administration.
→ p.10 “How to prevent missing a dose”

Tablet of BIKTARVY and how to store BIKTARVY Combination Tablets
BIKTARVY is a purple-brown tablet, as shown in

Top view

Side view

Bottom view

the pictures on the right (actual size).
[Blister packs]
Keep out of the reach of children.

A desiccant isplaced below
each tablet.

Keep tablets in the packs until use.
A desiccant is placed below each tablet.

Never accidentallyswallow a desiccant.

TabletNever accidentally swallow a desiccant.
Aluminum foil

3

DesiccantIntroduction /Table of contents

1

Keep tablets in the prescribed container.
Do not remove the desiccant from the container.

2Store at room temperature, away from moisture.
To open the container

1 ) While pressing down on the cap,

Desiccant2) Turn it counterclockwise.

Effects of BIKTARVY Combination Tablets
BIKTARVY Combination Tablets contain three active ingredients: bictegravir, emtricitabine,

Precautions

Keep out of the reach of children.

How to take BIKTARVY
Combination Tablets /Effects[Bottles]and tenofovir alafenamide. These active ingredients block the mechanisms involved in themultiplication of HIV, thereby suppressing the multiplication of the virus. There is more thanat the same time. This is why it is popular to administer two or more active ingredients at thesame time.

HIV
Integrase inhibitor

CCR5 inhibitor
Absorption/fusion
CD4 receptor

Bictegravir

What to do if you missa dose of BIKTARVY
Combination Tablets

one viral multiplication mechanism, and it is more effective to block two or more mechanisms

Invasion

HIV RNAmRNA

Reversetranscription

Budding/release

ProteinProteinsynthesis degradation/
modiﬁcation

CD4 cellNucleoside reverse
transcriptase inhibitor

Protease inhibitor

HIV reverse transcriptase

Emtricitabine

HIV protease

Tenofovir alafenamide

HIV integrase

4

Attaining U=U status

Non-nucleoside reverse
transcriptase inhibitor

Assembly

Side effects

IntegrationDNA
synthesis

For better treatment going forward
To achieve adequate effects, it has become popular to use more than one anti-HIV medicine in
combination. The combination of medicines that best suits the patient is selected to achieve convenienceof administration, taking into account the number of tablets to be taken, the number of daily doses, theinﬂuence of meals, the size of the medicine, and other factors.
Some medicines may not be administered concomitantly with other medicines.3) In such cases, anti-HIV
medicines are selected after conﬁrming the conditions and ongoing therapies of the patient.
Note 3) The inﬂuence of the concomitant administration of medicines is called “interaction.”

The numberof daily doses

The numberof tablets

The inﬂuenceof meals

The sizeof the tablet

Interaction

5

Introduction /Table of contents

Take one tablet of BIKTARVY once a day.

How to take BIKTARVY
Combination Tablets /Effects

BIKTARVY Combination Tablets is a drug that combines
three anti-HIV medicines in one tablet.

For example, you may decide to take it before breakfast, if you eat breakfast at the same time
every day. Alternatively, you may decide to take it before leaving home for work, if you leave
home at the same time every day. Determine the time of administration based on your work

Precautions

BIKTARVY Combination Tablets can be taken at the determined
time of administration, whether or not you have eaten a meal.

habits or lifestyle.

A BIKTARVY tablet is of the exact size as shown in the pictures below.
Top view

Bottom view

Side view(Actual size)→ p.3 “What are BIKTARVY Combination Tablets?”

Side effects

BIKTARVY tablets have a major axis of approx. 15 mm
and a minor axis of approx. 8 mm.

What to do if you missa dose of BIKTARVY
Combination Tablets→ p.10 “How to prevent missing a dose”

To suppress the multiplication of HIV, it is important to continue taking the medicine. To help
patients continue taking BIKTARVY Combination Tablets, they have characteristics as
Be sure to take one tablet of BIKTARVY once a day, at the determined time, without forgetting.
For the interaction of BIKTARVY Combination Tablets, see the next page (p.7).

6

Attaining U=U status

described above.

If you are taking other medicines
If you are taking medicines or supplements that are listed below, their concomitant use with BIKTARVY
Combination Tablets may cause side effects, or may decrease the efﬁcacy of BIKTARVY Combination
Tablets. If you are taking any medicines, supplements, or health foods, or if you plan to use new medicines,
supplements, or health foods, inform and consult with your healthcare provider (doctor or pharmacist) to
take necessary measures.

Medicines and foods that should not be taken concomitantly with BIKTARVY
Combination Tablets
Do not take BIKTARVY Combination Tablets if you are taking the following
medicines or foods.
Antimycobacterials

Rifampicin (Rifadin®)

AnticonvulsantsCarbamazepine (Tegretol®, etc.), phenobarbital (Phenobal®, etc.),
phenytoin (Aleviatin®, etc.), fosphenytoin (Fostoin®)

Herbal products

St. John’s wort

BIKTARVY Combination Tablets cannot be used concomitantly with other anti-HIV medicines. In
particular, do not take BIKTARVY Combination Tablets if you are taking anti-HIV medicines, etc. that
contain the following ingredients.
Other medicines that contain emtricitabine (Truvada® Combination Tablets)
Other medicines that contain tenofovir disoproxil fumarate (TDF) (Truvada® Combination Tablets,
Viread® Tablets, Tenozet® Tablets)
Other medicines that contain tenofovir alafenamide fumarate (TAF) (Descovy® Combination Tablets,
Vemlidy® Tablets, Odefsey® Combination Tablets)
Other medicines that contain lamivudine (Epzicom® Combination Tablets, Combivir® Combination
Tablets, Epivir® Tablets, Triumeq® Combination Tablets, Zeﬁx® Tablets)

Medicines and foods that require consultation with your doctor/pharmacist
before concomitant use
If you are taking the following medicines or foods, consult your healthcare provider(doctor/pharmacist) in advance.
Antiarrhythmics

Pilsicainide (Sunrythm®, etc.)

Antimycobacterials

Rifabutin (Mycobutin®)

Anti-HIV medicines

Atazanavir (Reyataz®)Hypoglycemic agents

Metformin (Metgluco®, etc.)

Antivirals

Aciclovir (Zovirax®, etc.), valaciclovir hydrochloride (Valtrex®, etc.),
valganciclovir hydrochloride (Valixa®)

Antacids that contain magnesium or aluminum; preparations that contain iron or calcium (containedin supplements, calcium preparations, iron preparations, antacids, laxatives, sucralfates, etc.)7

Introduction /Table of contents

Precautions for taking
BIKTARVY Combination Tablets
your hepatitis may relapse or rapidly deteriorate when you stop taking BIKTARVY Combination
Tablets. Therefore, before starting the administration of BIKTARVY
Combination Tablets, you need to conﬁrm that you are notinfected with HBV.
Note 4)Hepatitis B virus (HBV)The hepatitis B virus (HBV) causes chronic hepatitis B. HBV multiplies
continuously in hepatocytes. Therefore, it must be noted that even healthypeople can be carriers of HBV. It is estimated that 1.5 million Japanese people
are infected with HBV.

The following people cannot take BIKTARVY Combination Tablets.

Precautions

If you are infected with the hepatitis B virus (HBV)4) and take BIKTARVY Combination Tablets,

How to take BIKTARVY
Combination Tablets /Effects

If you are infected with hepatitis B

People who used to take bictegravir, emtricitabine, and/or tenofovir alafenamide, which are
the active ingredients of BIKTARVY Combination Tablets, and discontinued their use due toPeople who are taking rifampicin, carbamazepine, phenobarbital, phenytoin, fosphenytoin,
and/or herbal products that contain St. John’s wort
→ p.7 “If you are taking other medicines”

Precautions are required for people with a remarkable degreeof impaired kidney function.

What to do if you missa dose of BIKTARVY
Combination Tablets

hypersensitivity

If your creatinine clearance is < 30 mL/minute (except those on maintenance hemodialysis),

Precautions are required for people with a remarkable degreeof impaired liver function.

If you plan to become pregnant, consult your doctor.

Side effects

consult your doctor.

The effects of the administration of BIKTARVY Combination
are unknown. If you plan to become pregnant, be sure to
consult your doctor.
Avoid

breastfeeding

while

you

are

takingCombination Tablets.
8

BIKTARVY

Attaining U=U status

Tablets during pregnancy on a pregnant woman or the fetus

What should you do if you miss a dose of
BIKTARVY Combination Tablets?
The most important thing is to take measures toprevent missing a dose.
Not missing a dose is important for continuously
suppressing the multiplication of HIV. Missing a dose not
only compromises the effects of BIKTARVY Combination
Tablets, but may also result in the virus acquiring resistance(i.e., it may become impossible to suppress themultiplication of the virus with the medicine).

Should you miss a dose of BIKTARVY Combination Tablets…
If you miss a dose, take one dose of BIKTARVY Combination Tablets (one tablet) as soon as possible
after you realize that you have forgotten to take the medicine. Subsequently, continue taking BIKTARVY
Combination Tablets as scheduled.
If it is close to the time for the next administration when you realize that you have missed a dose, wait until
the next administration and take one dose as scheduled.

Never take two doses (two tablets) at a time.
Even if you have missed a dose, never take twodoses (two tablets) at a time. If you do take two
or more tablets at a time and feel any abnormal
effects, immediately consult your healthcare
provider (doctor or pharmacist).

9

Introduction /Table of contents

How to prevent missing a dose
Consult your doctor and determine the time of administration to prevent missing a dose, andbe sure to take the medicine at that time. For example, if you get up at the same time every
day, decide to take the medicine as soon as you get up, so that you can minimize the risk of
missing a dose.

How to take BIKTARVY
Combination Tablets /Effects

To prevent missing a dose, it is key to determine the time of administration.

Use the alarm function on your smartphone, etc.
Keep an administration record on your smartphone or pocketbook
It is also important to conﬁrm in advance what to do if you forget to take BIKTARVYPrecautions

Measures to prevent missing a dose

Combination Tablets.

Gilead Sciences, Inc. operates an ofﬁcial LINE
account that provides reminder and otherdrug adherence support tools:

10

Attaining U=U status

Use a pocketbook

Use an alarm function

Side effects

What to do if you missa dose of BIKTARVY
Combination Tablets→ p.9 “What should you do if you miss a dose of BIKTARVY Combination Tablets?”

Side effects of BIKTARVY
Combination Tablets
If you feel any physical abnormality including the following side effects while you are taking BIKTARVY
Combination Tablets, consult your doctor immediately.

Typical side effects
Headache, nausea, diarrhea, and other typical side effects
may occur.

Serious side effects
Kidney failure or severe kidney dysfunction
The administration of BIKTARVY Combination Tablets may result inkidney failure or severe kidney dysfunction. The following conditions
may occur due to kidney failure or severe kidney dysfunction.
Decreased urine
Swelling
Weariness
Decreased muscular strength
Bone pain
Increased urine
ThirstExcessive thirst

Regular kidney function tests will be performed, and you may be required to discontinue theadministration of BIKTARVY Combination Tablets if abnormality is observed. If any of the following
applies, inform your doctor in advance.
History of kidney disease
Ongoing administration of a medicine that imposes a burden on the kidneys

11Introduction /Table of contents

Lactic acidosis
Tablets, discontinue the administration and immediately consult your doctor regarding thepossibility of lactic acidosis.
Headache
Drowsiness
Lowering of consciousness

How to take BIKTARVY
Combination Tablets /Effects

If any of the following conditions occur due to the administration of BIKTARVY Combination

Hepatomegaly (fatty liver)
Severe hepatomegaly (fatty liver) may be caused by serious lactic acidosis. If any of thecontact your doctor.
Flap-like trembling of hands
NauseaPain or tenderness in the upper right abdomen

Precautions

following conditions are observed, suggesting suspected lactic acidosis or liver dysfunction,

Yellowing of skin

After you start taking BIKTARVY Combination Tablets, an inﬂammatory reaction (fever,diarrhea) may be caused in response to opportunistic infection, etc., due to the recovery of yourimmunity. Autoimmune diseases may also be caused.

Decreased bone density
Your bone density may decrease due to the administration of
BIKTARVY Combination Tablets.

What to do if you missa dose of BIKTARVY
Combination Tablets

Changes in your immune system

the administration of BIKTARVY Combination Tablets.

12

Attaining U=U status

Your skin may become discolored, mainly on the palms, due toSide effects

Skin discoloration

Attaining U=U status
Learn about U=U and undergo continuous treatment for
attaining U=U status“Undetectable equals Untransmittable” (U=U) is a status where the amount of HIV in the blood(“viral load”) is maintained at an undetectable level through treatment, which signiﬁes that thevirus is untransmittable through sex.1-4
To attain U=U status, it is critical to undergo continuous treatment and not skip any hospital visits.
1 Rodger A, et al.: JAMA 2016; 316(2): 171.
2 Rodger AJ, et al.: Lancet 2019; 393: 2428.
3 Bavinton BR, et al.: Lancet HIV 2018; 5(8): e438.
4 HIV Treatment Guidelines. March 2024.
People who maintain an undetectable viral load for six months or longer through treatment with
anti-HIV drugs cannot transmit HIV through sex.
It takes about six months before an undetectable viral load is attained, depending on the types of drugs
used. To continuously and reliably suppress HIV, the appropriate drugs must be taken as prescribed.
Reference: https://www.niaid.nih.gov/diseases-conditions/10-things-knowabout-hiv-suppression, accessed on June 27, 2024.

1–6 months
to achieve an
undetectableviral load

At least
6 months

Effectively no riskof transmitting HIV

to maintainan undetectableviral load

to a sexual partner
as long as people undergo
continuous treatment
and maintainan undetectable viral loadUndetectable
Take every pill every day as prescribed
Adapted from U=U Japan Project, “What is U=U?”
https://hiv-uujapan.org/summary/, accessed on June 27, 2024.
Masazumi Yamaguchi: JaNP + News Letter 2019, No. 40,
https://www.janpplus.jp/uploads/NL_vol40_web.pdf, accessed on June 27, 2024.

13

Introduction /Table of contents

Note that people may transmit HIV through sex if drug adherence is compromised or if
diseases is still possible even if an undetectable HIV load is maintained, and take the following
additional precautions.

Precautions in daily life
Protecting others

How to take BIKTARVY
Combination Tablets /Effects

treatment is interrupted. Also, remember that infection with other sexually transmitted

Do not donate your blood.
Consult your doctor concerning pregnancy
Avoid the shared use of toothbrushes andrazors to make sure that your bodily ﬂuids do
not come into contact with another person’s
mucousmembranesorwounds.

Use

Precautions

and childbirth.

U=U only applies to HIV. You can still be infected with
hepatitis B, chlamydia, gonorrhea, syphilis, and othersexually transmitted diseases. Be sure to use condoms
properly when you have sexual intercourse, as infection withany of the above can have unfavorable effects on yourimmune system and the progression of your disease.

Are there any other precautions?
Take the following precautions.

Side effects

Protecting yourself

What to do if you missa dose of BIKTARVY
Combination Tablets

condoms when you have sexual intercourse.

Be sure to continue your periodic hospital visits while you are being treated with drugs. Do
Do not provide your drugs to others.

14

Attaining U=U status

not stop taking your drugs or change how you take them except on the advice of your doctor.

Information sources concerning HIV infection
Information concerning HIV infection is available on the following websites.

AIDS Clinical Center, National Center for Global Health and Medicine
https://www.acc.ncgm.go.jp/ (Japanese version only)
AIDS Medical Center, National Hospital Organization
Osaka National Hospital
https://osaka.hosp.go.jp/department/khac/(Japanese version only)

AIDS Prevention Information Networkhttps://api-net.jfap.or.jp/ (Japanese version only)
Gilead Sciences “To Patients and Their Families”
https://www.hiv-pt-portal.jp (Japanese version only)

Contact Information

Gilead Sciences, Inc.
Gran Tokyo South Tower, 1-9-2 Marunouchi, Chiyoda-ku, Tokyo, 100-6616＜英語版＞
BVY24MR0092PA
Prepared in September 2024