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Tenofovir Disoproxil Fumarate Is A Nucleotide Analog Hiv-1 Reverse Transcriptase Inhibitor And An Hbv Reverse Transcriptase Inhibitor. Tenofovir Disoproxil Fumarate Is 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 Is 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 Is 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 For The Treatment Of Hiv-1 Infection: Tenofovir Disoproxil Fumarate Should Not Be Used In Combination With Atripla®, Complera ® , Descovy ® , Genvoya ® , Odefsey ® , Stribild ® , Truvad ® Or Vemlidy ® [ See Warnings And Precautions (5.4)]. 1.2 Chronic Hepatitis B Tenofovir Disoproxil Fumarate Is 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 For The Treatment Of Hbv 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 Was 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 Number 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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