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1 Indications & Usage Tenofovir Disoproxil Fumarate Tablets Are A Nucleotide Analog Hiv-1 Reverse Transcriptase Inhibitor And An Hbv Reverse Transcriptase Inhibitor. • Tenofovir Disoproxil Fumarate Tablets Are Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients 2 Years Of Age And Older. (1) • Tenofovir Disoproxil Fumarate Tablets Are Indicated For The Treatment Of Chronic Hepatitis B In Adults And Pediatric Patients 12 Years Of Age And Older. (1) 1.1 Hiv-1 Infection Tenofovir Disoproxil Fumarate Tablets Are Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients 2 Years Of Age And Older. The Following Points Should Be Considered When Initiating Therapy With Tenofovir Disoproxil Fumarate Tablets For The Treatment Of Hiv-1 Infection: • Tenofovir Disoproxil Fumarate Tablets Should Not Be Used In Combination With Atripla ® , Biktarvy ® , Complera ® , Descovy ® , Genvoya ® , Odefsey ® , Stribild ® , Truvada ® , Or Vemlidy ® [See Warnings And Precautions (5.4)]. 1.2 Chronic Hepatitis B Tenofovir Disoproxil Fumarate Tablets Are Indicated For The Treatment Of Chronic Hepatitis B In Adults And Pediatric Patients 12 Years Of Age And Older. The Following Points Should Be Considered When Initiating Therapy With Tenofovir Disoproxil Fumarate Tablets For The Treatment Of Chronic Hepatitis B Infection: • The Indication In Adults Is Based On Safety And Efficacy Data From Treatment Of Subjects Who Were Nucleoside-Treatment-Naïve And Subjects Who Were Treatment-Experienced With Documented Resistance To Lamivudine. Subjects Were Adults With Hbeag-Positive And Hbeag-Negative Chronic Hepatitis B With Compensated Liver Disease [See Clinical Studies (14.2)]. • Tenofovir Disoproxil Fumarate Tablets Were Evaluated In A Limited Number Of Subjects With Chronic Hepatitis B And Decompensated Liver Disease [See Adverse Reactions (6.1), Clinical Studies (14.2)]. • The Numbers Of Subjects In Clinical Trials Who Had Adefovir Resistance-Associated Substitutions At Baseline Were Too Small To Reach Conclusions Of Efficacy [See Microbiology (12.4), Clinical Studies ( 14.2)].
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