Gilead Sciences Announces Presentation of Data from Study 409 Demonstrating Durable Anti-HIV Activity of Preveon over 48 weeks [International Conference on AIDS (12th: 1998: Geneva, Switzerland)]

Jul 01 1~9B0 8:33:42 Via Fax 223192 uyb19 ae02O 0

202 371 9227 July 1, 1998

Page 002 Of 003

GILEAD
5SC I E N C E S
CONTACZT: Investors: LamaL$ue
(650) 573-4&58
Media: Laurie Hiurley
[phone]
Par Immediate Release
GILEAD) SCIENCES ANNOUNCES P'RESENTATION OP DATA FROM STUY 408
DEMONSTRATING DURABLE ANTI-mV ACTIVITY OF PREVEON OVER 48 WEEKS
Data Presented at 12th world AIDS Ccmfrrence in Geneva
Foster City, CA, July 1, 1998 -- Gilead Science, Inc. (N\asdaq: GILD) announced today the preetation of
data from a Phase fl/f clinical ill of PREVEON'7 (adefovfr dipivoxil) dlemonstrating statistically
sign'f'cat, du r ab le decreases i n levels of MV RNA for 48 weeks. 'hs results, from Study 408, plus
additional data on the activity, safety and resistance profile of PREV'EON, were preted at a Satellite
Symposium during the 12th World AIDS Conference in Geneva, Switzerland.
In Study 408, once daily treatment with PREVEON as part of comnbination rgmn was associated with a
decline in V RNA of approximately OAog1 at week 24 that was maitie through week 48. No change
was obseied in the placebo goup at week024 <.001). Changes Cocll counts at week 24 included an
i ncease o f approximately 5 cells/= ~i n t he PREEN group and a decrease of approximately 5 eeis/rnrn'
in the placebo group (p=.1).
Study 408 Trial Dse
Study 408 enrolled 442 patient who received treatment with eithe once daily PREVEON (120 mng) or placebo
in addition to any approved antti4~ treatment reimen the patient was rci~ing at the time of enrolinent
provided that the patient had been on a stable reg e for at least eight weeks. The study was placebo
controlled for 24 weeks, followed immedately by a 24 week opnlb hase during Which all coninuing
patients received S1~VON.
At baseline, patients had a median HIV RNA of 9,800 copies/niL and a median C])4 cell count of 326
cefls/mme. In addition,, the patients had previously received treatment with an average of three nucleoside
reverse transcniptase nhbitors and an average of three years of AZT treatment at the time of study enrolhnent
39 percent of patients were receiving a ptease anhibtor as part of their aniretroviral thrpy.
The disconinuation ratgs, changes in background antiretrviral therpy and Grade 3 or 4 adverse events over
the 24 week placebfrcvntro led portion of the study were similar in the PREVEON and placebo groups.
Adverse events associated with PREVEON included changes In laboratory markers of renal function,
gastrointestinal side effects, including nausea and vomiting, and weight loss, During the first 24 weeks, mld to
moderate changes in laboratory markers of renal function were oberved in 1% of patients assigned to
PREVEON. By weeki 48, changes in 'akeys of renal funciton were detected In 32% of patients treated with
RIWEQrNV.-he lboratory changes weare genery nrevribl po1 o se rductioin r dos 1einrution. Seven

333 LAKESID)E DRIVE * FOSTER crr1 CALIFORNIA 944Q4 * USA
TELEPHONE: [phone] " FAX; 650/578-9264 " WWW.CrLEAD)UCOM