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U.S. Department of Health and Human Services

Safety

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Viread (tenofovir disoproxil fumarate) Oct 2003

Audience: Infectious Disease and other healthcare professionals

Gilead Sciences, Inc. notified healthcare professionals of a high rate of early virologic failure and emergence of nucleoside reverse transcriptase inhibitor (NRTI) resistance associated mutations observed in a clinical study of HIV-infected treatment-naïve patients receiving a once-daily triple NRTI regimen containing didanosine enteric coated beadlets (Videx EC, Bristol-Myers Squibb), lamivudine (Epivir, GlaxoSmithKline), and tenofovir disoproxil fumarate (Viread, Gilead). Based on these results, Tenofovir DF in combination with didanosine and lamivudine is not recommended when considering a new treatment regimen for therapy-naïve or experienced patients with HIV infection. Patients currently on this regimen should be considered for treatment modification.

[October 14, 2003 - Letter - Gilead Sciences]