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) -0.04 (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) +0.07 (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.