Introduction / Introduction of contents Table How to take BIKTARVY BIKTARVY take to How / Tablets Combination Eects For People Taking BIKTARVY® Combination Tablets Precautions Editorial Supervisor Takuma Shirasaka Director of AIDS Medical Center National Hospital Organization Osaka National Hospital What to do if you miss miss do if you to What a dose of BIKTARVY Tablets Combination Side eects Contact Information Gilead Sciences, Inc. Gran Tokyo South Tower, 1-9-2 Marunouchi, Chiyoda-ku, Tokyo, 100-6616 BVY19DS0086PA Created in May 2019 Additional information Additional Introduction For People Taking BIKTARVY Combination Tablets Table of contents / Introduction of contents Table This leaflet was created for people who take BIKTARVY Combination Tablets. It includes information about the characteristics of BIKTARVY Combination Tablets, 1 Introduction how to take BIKTARVY Combination Tablets, what to do if you forget to take 3 What are BIKTARVY Combination Tablets? BIKTARVY Combination Tablets, the side eects of BIKTARVY Combination Tablets, and precautions for taking BIKTARVY Combination Tablets. Read this 5 For better treatment going forward How to take BIKTARVY BIKTARVY take to How / Tablets Combination Eects leaflet carefully before taking BIKTARVY Combination Tablets. 7 If you are taking other medicines The treatment of HIV (human immunodeficiency virus) infection is aimed at 8 Precautions for taking inhibiting the multiplication of HIV, thereby preventing the onset of AIDS. BIKTARVY Combination Tablets BIKTARVY Combination Tablets is one of the drugs called “anti-HIV medicines” Precautions that suppress the multiplication of HIV. 9 What should you do if you miss a dose of To safely achieve the adequate ecacy of an anti-HIV medicine, it is important to BIKTARVY Combination Tablets? take it correctly. 10 How to prevent missing a dose A medical decision needs to be made based on your own particular circumstances before starting the administration of BIKTARVY Combination Tablets. 11 Side eects of BIKTARVY Combination Tablets Listen carefully to the explanation provided by your healthcare provider (doctor, What to do if you miss miss do if you to What a dose of BIKTARVY Tablets Combination nurse, or pharmacist) and follow their instructions. 13 Is there anything else you should know? 13 Information sources concerning HIV infection If you have any questions about the administration of BIKTARVY Combination Tablets, consult your healthcare provider (doctor, nurse, or pharmacist). Side eects 1 2 information Additional Introduction For People Taking BIKTARVY Combination Tablets Table of contents / Introduction of contents Table This leaflet was created for people who take BIKTARVY Combination Tablets. It includes information about the characteristics of BIKTARVY Combination Tablets, 1 Introduction how to take BIKTARVY Combination Tablets, what to do if you forget to take 3 What are BIKTARVY Combination Tablets? BIKTARVY Combination Tablets, the side eects of BIKTARVY Combination Tablets, and precautions for taking BIKTARVY Combination Tablets. Read this 5 For better treatment going forward How to take BIKTARVY BIKTARVY take to How / Tablets Combination Eects leaflet carefully before taking BIKTARVY Combination Tablets. 7 If you are taking other medicines The treatment of HIV (human immunodeficiency virus) infection is aimed at 8 Precautions for taking inhibiting the multiplication of HIV, thereby preventing the onset of AIDS. BIKTARVY Combination Tablets BIKTARVY Combination Tablets is one of the drugs called “anti-HIV medicines” Precautions that suppress the multiplication of HIV. 9 What should you do if you miss a dose of To safely achieve the adequate ecacy of an anti-HIV medicine, it is important to BIKTARVY Combination Tablets? take it correctly. 10 How to prevent missing a dose A medical decision needs to be made based on your own particular circumstances before starting the administration of BIKTARVY Combination Tablets. 11 Side eects of BIKTARVY Combination Tablets Listen carefully to the explanation provided by your healthcare provider (doctor, What to do if you miss miss do if you to What a dose of BIKTARVY Tablets Combination nurse, or pharmacist) and follow their instructions. 13 Is there anything else you should know? 13 Information sources concerning HIV infection If you have any questions about the administration of BIKTARVY Combination Tablets, consult your healthcare provider (doctor, nurse, or pharmacist). Side eects 1 2 information Additional What are BIKTARVY Combination Tablets? / Introduction of contents Table BIKTARVY is a medicine for HIV infection that suppresses the multiplication of the virus in the blood1). Eects of BIKTARVY Combination Tablets When BIKTARVY Combination Tablets are administered and the multiplication of HIV in the blood is BIKTARVY Combination Tablets contain three active ingredients: bictegravir, emtricitabine, suppressed, immune-compromised patients recover some of their immune function and are less likely to and tenofovir alafenamide. These active ingredients block the mechanisms involved in the acquire opportunistic infections2). multiplication of HIV, thereby suppressing the multiplication of the virus. There is more than Herpesvirus one viral multiplication mechanism, and it is more eective to block two or more mechanisms Note 1) Amount of virus in the blood infection Candida at the same time. This is why it is popular to administer two or more active ingredients at the esophagitis The amount of virus in the blood is represented by the viral count in 1 mL same time. BIKTARVY take to How / Tablets Combination Eects of plasma. It indicates the treatment start time and/or the eects of the anti-HIV medicines. The goal of treatment is to maintain a viral concentration that is below the detection limit over a long period of time. Note 2) Opportunistic infections Mycobacterium HIV Signifies infections caused by weakly pathogenic microorganisms that do avium complex (MAC) not cause infections in people with normal immune function. infection CCR5 inhibitor Integrase inhibitor Opportunistic infections include candida esophagitis, herpesvirus Precautions infection, and Mycobacterium avium complex (MAC) infection. Bictegravir Absorption/fusion CD4 receptor How to take BIKTARVY Combination Tablets Invasion Integration Take one tablet of BIKTARVY once a day, with or without food. DNA To avoid forgetting to take BIKTARVY, and to ensure that it is taken at a regular interval, consult your synthesis doctor and decide the time of administration. HIV RNA mRNA → p.10 “How to prevent missing a dose” Reverse transcription Assembly Budding/release What to do if you miss miss do if you to What a dose of BIKTARVY Tablets Combination Tablet of BIKTARVY and how to store BIKTARVY Combination Tablets Protein Protein synthesis degradation/ modification Non-nucleoside reverse BIKTARVY is a purple-brown tablet, as shown in the Top view Bottom view Side view transcriptase inhibitor CD4 cell Protease inhibitor pictures on the right (actual size). Nucleoside reverse Keep BIKTARVY Combination Tablets out of the transcriptase inhibitor HIV reverse transcriptase reach of children. Emtricitabine HIV protease Keep BIKTARVY Combination Tablets in the Tenofovir alafenamide Side eects HIV integrase prescribed container. 1 Leave the desiccant in the container (do not remove it). Store BIKTARVY Combination Tablets at room temperature, 2 away from moisture. To uncap the container of BIKTARVY Combination Tablets: Desiccant 1) While pressing down on the cap, 2) Twist the cap to the left. 3 4 information Additional What are BIKTARVY Combination Tablets? / Introduction of contents Table BIKTARVY is a medicine for HIV infection that suppresses the multiplication of the virus in the blood1). Eects of BIKTARVY Combination Tablets When BIKTARVY Combination Tablets are administered and the multiplication of HIV in the blood is BIKTARVY Combination Tablets contain three active ingredients: bictegravir, emtricitabine, suppressed, immune-compromised patients recover some of their immune function and are less likely to and tenofovir alafenamide. These active ingredients block the mechanisms involved in the acquire opportunistic infections2). multiplication of HIV, thereby suppressing the multiplication of the virus. There is more than Herpesvirus one viral multiplication mechanism, and it is more eective to block two or more mechanisms Note 1) Amount of virus in the blood infection Candida at the same time. This is why it is popular to administer two or more active ingredients at the esophagitis The amount of virus in the blood is represented by the viral count in 1 mL same time. BIKTARVY take to How / Tablets Combination Eects of plasma. It indicates the treatment start time and/or the eects of the anti-HIV medicines. The goal of treatment is to maintain a viral concentration that is below the detection limit over a long period of time. Note 2) Opportunistic infections Mycobacterium HIV Signifies infections caused by weakly pathogenic microorganisms that do avium complex (MAC) not cause infections in people with normal immune function. infection CCR5 inhibitor Integrase inhibitor Opportunistic infections include candida esophagitis, herpesvirus Precautions infection, and Mycobacterium avium complex (MAC) infection. Bictegravir Absorption/fusion CD4 receptor How to take BIKTARVY Combination Tablets Invasion Integration Take one tablet of BIKTARVY once a day, with or without food. DNA To avoid forgetting to take BIKTARVY, and to ensure that