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Versus EmtricitabinePlus TDF - HIVandHepatitis.com

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Summary of Safety Data<br />

<strong>TDF</strong><br />

(N=53)<br />

FTC/<strong>TDF</strong><br />

(N=52)<br />

Adverse Event, Patients with<br />

Grade 3 or 4 AE 1 (2%) 4 (8%)<br />

SAE (one considered related to study drug: ALT<br />

flare*)<br />

6 (11%) 10 (19%)<br />

AE that resulted in DC 0 0<br />

Death (Pulmonary cancer with osseous metastasis) 0 1 (2%)<br />

Laboratory Abnormalities, Patients with<br />

Grade 3 or 4 laboratory abnormality 10 (19%) 12 (23%)<br />

Grade 4 ALT (>10 x ULN) and > 2 x Baseline* 0 2 ( 4%)<br />

Confirmed ≥0.5 mg/dL increase in creatinine 0 0<br />

Confirmed CrCl decline to

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