What to do if you missa dose of DESCOVY
Combination Tablets /Precautions

Director of the AIDS Clinical Center
National Center for Global Health and Medicine

Side effects

How to take DESCOVY
Combination Tablets

Editorial Supervisor

Taking DESCOVY
Combination Tablets
during pregnancy /Additional information

For People
Taking DESCOVY®
Combination Tablets
Shinichi Oka

Effects of DESCOVY
Combination Tablets

Introduction /Table of contents

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

A medical decision needs to be made based on your circumstances before
starting the administration of DESCOVY Combination Tablets.
Listen carefully to the explanation provided by your healthcare providers(physicians, nurses and pharmacists) and follow their instructions.

If you have any questions about the administration of DESCOVY CombinationTablets, consult your healthcare providers (physicians, nurses and pharmacists).

This leaflet is a revised Japanese version of the “Patient Information of DESCOVY” which accompanies “DESCOVY
Full Prescribing Information” in the U.S.
The content was compiled under the supervision of Dr. Shinichi Oka (Director of AIDS Clinical Center, National
Center for Global Health and Medicine)1

01

Introduction

3

What are DESCOVY Combination Tablets?
● Characteristics of DESCOVY Combination Tablets● Effects of DESCOVY Combination Tablets

What should you do if you miss a dose ofDESCOVY Combination Tablets?

10Precautions for taking DESCOVY
Combination Tablets● If you are infected by hepatitis B virus● If you have symptoms of lactic acidosis● If liver dysfunction occurs

11

What are the side effects of DESCOVY
Combination Tablets?

13

Taking DESCOVY Combination Tablets
during pregnancy?
● Breast-feeding● If you would like to know more about HIV infection

14

What to do if you missa dose of DESCOVY
Combination Tablets /Precautions

9Side effects● Concomitant use of DESCOVY Combination Tablets with other medicines

How to take DESCOVY
Combination Tablets

How should DESCOVY Combination Tablets be taken?

Is there anything else you should know?
● Precautions in everyday life
● How to store DESCOVY Combination Tablets● How to uncap the container of DESCOVY Combination Tablets

2Taking DESCOVY
Combination Tablets
during pregnancy /Additional information

5

Introduction /Table of contents

Table of contents

Effects of DESCOVY
Combination Tablets

For People Taking DESCOVY
Combination Tablets

What are DESCOVYCombination Tablets?
DESCOVY is a medicine for HIV infection that reduces the amountof the virus in the blood1).
When DESCOVY Combination Tablets are administered and HIV activity in the blood is suppressed,
immune-compromised patients recover some of their immune function and are less likely to acquire
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)

Candidaesophagitis

Opportunistic infections

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

Mycobacterium
avium
complex (MAC)
infection

Characteristics of DESCOVY Combination Tablets
DESCOVY Combination Tablets contain two types of nucleoside reverse transcriptase inhibitors. One isemtricitabine, and the other is tenofovir alafenamide. You can take two types of medicines with a once
daily administration of only one tablet of DESCOVY, thus reducing the burden of administration. For actualtreatment, other anti-HIV medicines are usually taken with DESCOVY Combination Tablets.
DESCOVY does not completely cure HIV infection or AIDS through short-term administration, but
suppresses HIV activity through continued administration. Continued treatment is required, while taking
precautions against opportunistic infections and other symptoms.

3Introduction /Table of contents

Emtricitabine and tenofovir alafenamide contained in DESCOVY Combination Tablets suppress
the activity of HIV reverse transcriptase3), which is necessary for HIV to multiply in the body, andprevent the growth of HIV.
Note 3)

HIV reverse transcriptase

Effects of DESCOVY
Combination Tablets

Effects of DESCOVY Combination Tablets

How to take DESCOVY
Combination Tablets

A type of enzyme that works when HIV multiplies in the body; A specific
type of enzyme contained in the virus

HIVCCR5 inhibitor

Integrase inhibitorAbsorption/fusion
CD4 receptor

What to do if you missa dose of DESCOVY
Combination Tablets /Precautions

Invasion
Integration
DNAsynthesis
HIV RNAmRNA

Reversetranscription

Budding/release

ProteinProteinsynthesis degradation/modification

CD4 cellProtease inhibitor

Nucleoside reverse
transcriptase inhibitor
HIV reverse transcriptase

DESCOVY Combination Tablets

HIV protease

Emtricitabine

HIV integrase

Side effects

Non-nucleoside reverse
transcriptase inhibitor

AssemblyIn

addition

tonucleosidereversetranscriptase

inhibitors,

anti-HIV

medicines

includenon-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, and CCR5inhibitors, which respectively have different mechanisms of action. In the treatment of HIV infection,
DESCOVY Combination Tablets are usually used in combination with these other medicines.

4Taking DESCOVY
Combination Tablets
during pregnancy /Additional information

Tenofovir alafenamide

How should DESCOVY
Combination Tablets be taken?
In general, take one tablet of DESCOVY once a day.
DESCOVY Combination Tablets may be taken regardless of when meals are taken.
There are two types of DESCOVY tablets (LT and HT) that contain different dosages of tenofovir
alafenamide (TAF). Each of these tablets is used separately depending on other anti-HIV medicines that areconcurrently administered. Make sure that you take the medicines as prescribed by your doctor.

This is a medicine you take.

Check

DESCOVY Combination Tablets LTCheckDESCOVY Combination Tablets HT

If administered concurrently with

If not administered concurrently withritonavir or cobicistat

ritonavir or cobicistat

DESCOVY Combination Tablets LT is a gray

DESCOVY Combination Tablets HT is a bluetablet. One tablet contains emtricitabinetablet. One tablet contains emtricitabine

200 mg and tenofovir alafenamide 10 mg.

200 mg and tenofovir alafenamide 25 mg.

Top view

Top view

Bottom view

Bottom view

Side view

Side view5Introduction /Table of contents

Taking the medicine every day is of the utmost importance for continuously suppressing themay multiply in the body or the medicine may become ineffective, and symptoms may worsen.
Follow your doctor’s instructions and take DESCOVY Combination Tablets and other medicines
properly every day.
Do not discontinue taking DESCOVY Combination Tablets based only on your own judgment. If
you have any problems, immediately contact a hospital. In addition, continue to see and consult

What to do if you missa dose of DESCOVY
Combination Tablets /Precautions

How to take DESCOVY
Combination Tablets

your doctor regularly concerning your condition.

Effects of DESCOVY
Combination Tablets

activity of the virus. If you miss taking the medicine for even a short period of time, the virus

6

Taking DESCOVY
Combination Tablets
during pregnancy /Additional information

Side effects

Notes

Concomitant use of DESCOVY Combination Tablets with other medicines
Some medicines may not be administered concomitantly with DESCOVY Combination Tablets, or requireprecaution for concomitant use. If you take such medicines concomitantly with DESCOVY Combination
Tablets, side effects may occur or therapeutic effects may decrease. Therefore, inform and consult withyour healthcare providers (physician, pharmacist, etc.) about all medicines that you are taking (including
prescription medicines, over-the-counter medicines, vitamins, herb supplements, and health foods) totake necessary measures.

Do not take DESCOVY Combination Tablets if you are taking
the following anti-HIV medicines, anti-viral medicines, etc.
● Other medicines that contain emtricitabine· Truvada® Combination Tablets· Stribild® Combination Tablets· Odefsey® Combination Tablets· Symtuza® Combination Tablets· Emtriva®
· Complera® Combination Tablets· Genvoya® Combination Tablets· BIKTARVY® Combination Tablets● Other medicines that contain TDF· Truvada® Combination Tablets· Stribild® Combination Tablets· Viread®
· Tenozet®

· Complera® Combination Tablets● Other medicines that contain tenofovir alafenamide fumarate· Genvoya® Combination Tablets· Odefsey® Combination Tablets· BIKTARVY® Combination Tablets· Symtuza® Combination Tablets● Other medicines that contain lamivudine· Epzicom® Combination Tablets· Triumeq® Combination Tablets· Combivir® Combination Tablets· Zefix®

● Antiviral medicines· Telaprevir (Telavic®)

7· Epivir®

Introduction /Table of contents● Hypnotics and sedatives, anxiolytics● Antivirals· Phenobarbital (Phenobal®, etc.)· Aciclovir (Zovirax®, etc.)· Ganciclovir (Denosine®)· Valaciclovir hydrochloride (Valtrex®, etc.)

Effects of DESCOVY
Combination Tablets

Precautions need to be taken if you take the following medicines(or medicines containing the following ingredients) concomitantly withDESCOVY Combination Tablets.

· Fosphenytoin (Fostoin®)● Herbal products· Phenytoin (Aleviatin®, etc.)· St. John’s wort
● Antibiotics· Rifabutin (Mycobutin®)● Tuberculosis preparations· Rifampicin (Rifadin®, etc.)

Write down the medicines that you are currently taking.

Side effects*Including prescription medicines, over-the-counter medicines, vitamins, herbal supplements, health foods, etc.

What to do if you missa dose of DESCOVY
Combination Tablets /Precautions· Carbamazepine (Tegretol®, etc.)

How to take DESCOVY
Combination Tablets· Valganciclovir hydrochloride (Valixa®)● Antiepileptics

If you do not know whether or not the medicine you areor pharmacist.
In addition, do not start taking any new medicine while
you are taking DESCOVY Combination Tablets without
asking your doctor or pharmacist first.

8Taking DESCOVY
Combination Tablets
during pregnancy /Additional information

taking is included in this list, ask your prescribing doctor

What should you do if you miss a dose ofDESCOVY Combination Tablets?
The most important thing is to take measures toprevent missing a dose.
Not missing a dose is the most important course of action forcontinuously suppressing HIV activity. Make out a schedule fortaking DESCOVY Combination Tablets at a regular time in order toensure that you don’t forget.

Should you miss a dose of DESCOVY Combination Tablets…
If you miss a dose, take one dose of DESCOVY Combination Tablets (one tablet) as soon as possible
after you realize that you have forgotten to take the medicine. Subsequently, continue taking DESCOVY
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.

What you must not do if you miss taking a dose!
Never take two or more doses of DESCOVY
Combination Tablets (two or more tablets) at a time.
You should ask your healthcare provider (doctor orpharmacist) in advance what to do if you forget totake DESCOVY Combination Tablets.

9Introduction /Table of contents

Precautions for taking DESCOVY
Combination Tablets

hepatitis condition may relapse or rapidly deteriorate when you stop taking DESCOVY
Combination Tablets. Therefore, before starting the administration of DESCOVY CombinationTablets, you need to check that you are not infected by HBV.
Note 4)Hepatitis B virus (HBV)

Hepatitis B virus causes chronic hepatitis B. HBV continues to multiply inhepatocytes, but does not kill cells directly. Therefore, it must be notedthat even healthy people can be carriers of HBV. It is estimated that 1.5
million Japanese people are infected by HBV.

If you have symptoms of lactic acidosis

How to take DESCOVY
Combination Tablets

If you are infected by hepatitis B virus (HBV)4) and take DESCOVY Combination Tablets, yourEffects of DESCOVY
Combination Tablets

If you are infected by hepatitis B virus

Tablets, blood lactate level may become high and you may develop lactic acidosis. Lactic
acidosis is very serious and life-threatening. If you have the following symptoms, immediatelycontact the hospital.
● Feel very weak or tired● Have unusual muscle pain

● Feel cold, numbness, or pain, especially inyour arms and legs

● Have trouble breathing● Feel dizzy or lightheaded● Have a fast or irregular heartbeat● Have stomach pain with nausea or vomiting

What to do if you missa dose of DESCOVYCombination Tablets /Precautions

When you take a nucleoside reverse transcriptase inhibitor such as DESCOVY Combination

When you take a nucleoside reverse transcriptase inhibitor
such as DESCOVY Combination Tablets, you may develop fatin your liver (steatosis) and your liver may become enlarged

Side effects

If liver dysfunction occurs(hepatomegaly). Immediately contact the hospital if you have

● Your skin or the whites of your eyes

turn yellow (jaundice)● Urine color is thicker than before● Stool color is whiter than before● Loss of appetite for several days or longer● Have nausea● Have pain, aching, or tenderness

on the right side of your stomach area

10

Taking DESCOVY
Combination Tablets
during pregnancy /Additional information

any of the following symptoms.

What are the side effects of DESCOVY
Combination Tablets?
After administration of DESCOVY Combination Tablets,
the following serious adverse effects may occur:
Recurrence or worsening of the hepatitis B, lactic acidosis, fatty liver,or hepatomegaly symptoms described in “Precautions for taking
DESCOVY Combination Tablets” (page 10)
Changes in body fat 5)
Changes in your immune system6)
Kidney problems7)
Bone problems8)
Note 5)

Changes in body fat

When you take anti-HIV medicines such as DESCOVY Combination
Tablets, your body may put on fat on the chest or abdomen or from theneck to the upper back, or it may lose fat from the legs, arms, or face.

Note 6)

Changes in your immune system

After the rapid improvement in your immunity following theadministration of anti-HIV medicines, you may feel abnormalities in yourbody as your immune system functions.

Note 7)

Kidney problems

Anti-HIV medicines may cause kidney problems. In clinical studies,
DESCOVY Combination Tablets had less of an impact on kidney lab test
results than the comparator medicine, TRUVADA Combination Tablets.
However, DESCOVY Combination Tablets may cause additional kidney
problems, including kidney failure and dysfunction, or worsen existingkidney problems. Blood and urine tests are required both before andduring administration of DESCOVY Combination Tablets. Your doctor may
tell you to stop taking DESCOVY Combination Tablets if your kidney
function worsens during administration of DESCOVY.

Note 8)Bone problems

Bone problems may occur as a result of HIV infection or the effect ofDESCOVY Combination Tablets or other medicines. If a bone problem issuspected, you may need to take a bone density test, etc.

11Introduction /Table of contents

Have or have had any bone problems
Have any other medical conditions

The most common side effects
from taking DESCOVY Combination
Tablets are nausea, diarrhea,
headache, etc.

Although there are cases where you need to discontinue DESCOVY Combination Tablets due toside effects, never discontinue the medicine or change how you take it based only on your own
judgment. If you notice any physical abnormalities, contact your hospital immediately.

12

Taking DESCOVYCombination Tablets
during pregnancy /Additional information

Side effects

Notes

How to take DESCOVY
Combination Tablets

Have or have had any kidney problems

What to do if you missa dose of DESCOVY
Combination Tablets /Precautions

Have or have had any liver problems, including HBV infection

Effects of DESCOVY
Combination Tablets

Before administration of DESCOVY Combination Tablets, make sure
to tell your healthcare provider if any of the following apply to you.

Taking DESCOVY Combination
Tablets during pregnancy?
The effects of DESCOVY Combination Tablets on a pregnant woman
or the fetus are unknown.
Adequately consult your doctor about whether or not to take DESCOVY Combination Tablets during pregnancy.
If you are pregnant or plan to become pregnant, be sure to tell your doctor before taking DESCOVY
Combination Tablets.

Breast-feeding
Avoid breast-feeding, since it may result in HIV beingtransmitted from mother to infant.
Emtricitabine contained in DESCOVY Combination Tablets
may be excreted in milk. It is unknown whether tenofovir
alafenamide fumarate is excreted in milk. In addition, the effectsof DESCOVY Combination Tablets on the infant are unknown.
Ask your doctor about meals for infants.

If you would like to know more about HIV infection, access:
AIDS Clinical Center, National Center for Global Health and Medicine
https://www.acc.go.jp/ (Japanese version only) (Viewed on September 10, 2021)
AIDS Medical Center, National Hospital Organization
Osaka National Hospital
https://osaka.hosp.go.jp/department/khac/center/(Japanese version only) (Viewed on September 10, 2021)

AIDS Prevention Information Networkhttps://api-net.jfap.or.jp/(Japanese version only) (Viewed on September 10, 2021)

13Introduction /Table of contents

Is there anything else
you should know?

Do not give DESCOVY Combination Tablets to others.

Precautions in everyday life
Overseas research has demonstrated1-4 that HIV transmission to a sexual partner can beprevented* by taking effective treatment that persistently suppresses the HIV RNA content toless than 200 copies per milliliter of blood. However, it has not been proven that taking thetreatment will ensure complete prevention of HIV transmission.
The partner could be infected with sexually transmitted disease such as hepatitis B,
chlamydia, gonorrhea, and syphilis, or may have a type of HIV that does not respond as wellto the treatment. Thus, proper use of condoms is advised when engaging in sexual activities
in order to prevent becoming infected by such sexually transmitted diseases.
2: Rodger AJ, et al.: Lancet 2019; 393: 2428
4: HIV Treatment Guidelines, March 2021

What to do if you missa dose of DESCOVY
Combination Tablets /Precautions*Undetectable = Untransmittable; U = U
1: Rodger A, et al.: JAMA 2016; 316(2): 171
3: Bavinton BR, et al.: Lancet HIV 2018; 5(8): e438

How to store DESCOVY Combination Tablets
Keep DESCOVY Combination Tablets out of the reach of children.
Keep DESCOVY Combination Tablets in its original container.
Store DESCOVY Combination Tablets at room temperature,away from moisture. Do not store DESCOVY Combination
Tablets at extremely high or low temperatures.
Be sure to close the cap of the container after taking out atablet for administration.

How to take DESCOVY
Combination Tablets

Get regular examinations while taking DESCOVY Combination Tablets. Do not discontinue orchange how to take DESCOVY Combination Tablets based on your own judgment alone
without instructions from your doctor.

Effects of DESCOVY
Combination Tablets

Take note of the following points.

Desiccant

How to uncap the container of DESCOVY Combination Tablets
Follow the characteristic method for uncapping the container

1Side effects

Leave the desiccant (photo on the right) in the container during storage.

of DESCOVY Combination Tablets.

2) Turn the cap to the left.

Citation: DESCOVY Full Prescribing Information (Issued: April 2016), Gilead Sciences, Inc.

14

Taking DESCOVY
Combination Tablets
during pregnancy /Additional information

21) While holding down the cap,Contact Information

Gilead Sciences, Inc.
Gran Tokyo South Tower, 1-9-2 Marunouchi, Chiyoda-ku, Tokyo, 100-6616〈英語版〉
DVY21DS0130PA Created in November 2021