Sixth International Congress Drug Therapy in HIV Infection 17-21 November, 2002 Glasgow, UK

Background: Tenofovir DF is a single-tablet, once-daily nucleotide reverse transcriptase inhibitor with activity against wild type and nucleoside-resistant HIV.

Methods: Adverse event (AE) and laboratory data were pooled and analyzed from two Phase 2-3 intensification studies in treatment-experienced patients (mean duration prior therapy: >5 years): 443 patients who received TDF 300 mg and 210 patients who received matching placebo (PLB) during the 24 week double-blind periods of the studies. Including crossovers from PLB to TDF, a total of 687 patients received TDF 300 mg. Extended-dosing periods were also assessed for safety and tolerability of TDF in the 687 patients (median total duration: 96 weeks; maximum 191 weeks).

Results: During the initial 24 weeks, the severity and incidence of AE and laboratory abnormalities (LA), as well as the incidence of therapy discontinuations for AE (¡Ü3%) were similar between the PLB and TDF groups. During the extended dosing periods of the studies, the incidence of AE and LA increased slightly, but remained similar to that observed with placebo during the initial 24 weeks. Serum creatinine elevations and hypophosphatemia occurred sporadically, were transient in nature and resolved without interruption of treatment. No patient discontinued TDF for increase in serum creatinine or hypophosphatemia. Finally, no evidence of TDF-related bone marrow, mitochondrial toxicity or effects on lipid metabolism have been detected.

Conclusions: In the placebo-controlled Phase 2-3 studies of tenofovir DF conducted to date, the severity and incidence of AE and LA, as well as the proportion of patients discontinuing tenofovir DF, were similar to PLB.

Presenting author: Dion Coakley

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2002-11-17
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