Background: Viread (TDF) is a single tablet, once-daily nucleotide RTI with potent activity against wild-type and nucleoside resistant HIV.  A global EAP was initiated in March 2001 for patients who failed prior HAART and had limited treatment options.  As of October 2001, 5442 patients were enrolled globally: 3111 (U.S.), 1108 (France), 462 (U.K.), 456 (Spain), 129 (Germany), 34 (Italy), 19 (Other).

Methods:  Patients with HIV infection,  > 18 years old. who failed prior HAART received open-label TDF 300 mg qd in combination with other ARTs. Demographics, prior/concurrent ARTs, serious adverse events (SAEs), and discontinuations were collected. CD4 count and HIV RNA were evaluated at baseline and each visit in France, Germany, and Italy EAPs.

Results: Data on 1360 patients in the U.S. (through October 15, 2001; up to 30 weeks); 813 in France (through August 13, 2001, up to 16 weeks).

Baseline Demographics	U.S. (n =1360)	France (n=813)
Median Age (yrs)	42	41
Male (%)	92	81
Median CD4 count (cells/mm3)	90	176
CD4 count < 200 cells/mm3 (%)	72	56
Median HIV RNA (log10 copies/mL)	4.99	4.82
HIV RNA > 100,000 copies/mL (%)	49	39
Median # Prior ARTs	9	Not analyzed
Median years since HIV diagnosis	Not analyzed	10.8
Median # Concurrent ARTs	3	3

French EAP: median change in CD4 count at months, 1 and 3: +14.5 (n=164) and +40.5 cells/mm³ (n=32).  Median HIV RNA reduction at months 1 and 3:  -0.47 (n=139) and -0.95 log₁₀ copies/mL (n=30).  Adverse drug reactions (ADRs) reported in 24 (3%) patients; GI events being most common (1%); drug discontinuation in 8 (<1%) patients; SADRs in 1% patients. U.S. EAP: 2% discontinued; 1% AEs; 5% SAEs; all individual SAEs reported in <1% patients. Global EAP: 4% SAEs, most unrelated to TDF.  Further data will be presented including German, Italian, Spanish, UK EAPs.

Conclusions:   Data from ART-experienced patients treated with TDF in the global EAP are consistent with that observed in controlled clinical trials of TDF.