MEMORANDUM
DATE: September 14, 2001
TO: Advisory Committee Members and Guests
FROM: Tenofovir Review Team
THROUGH: Debra Birnkrant, M.D.
Acting Director
Division of Antiviral Drug Products
SUBJECT: Errata for Background Package for NDA 21-356: VIREAD (tenofovir disoproxil fumarate)
Page 10:
Section: IV. Summary of Clinical Virology:
Table IVD: HIV RNA Response by Number of Baseline TAMs
|
# baseline TAMs |
Mean DAVG24 (N) |
|
|
Tenofovir |
Placebo |
|
|
No TAMs |
-0.80 (68) |
-0.11 (29) |
|
Any TAMs |
-0.50 (154) |
0 (81) |
|
1 –2 TAMs |
-0.66 (55) |
-0.4 (33) |
|
3 TAMs |
-0.44 (59) |
+0.04 (29) |
|
> 4 TAMs |
-0.35 (40) |
+0.03 (19) |
|
> 3 TAMs + M41L or L210W |
-0.21 (57) |
+0.01 (29) |
|
> 3 TAMs / No M41L or L210W |
-0.67 (42) |
+0.7 (19) |
Page 18
:Section: V. Safety Summary:
Subsection: f. Clinical Assessment of Bone Abnormalities: Incidence of Clinical Fractures
The mean time to fracture event was 311 days 296 days.