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 81 1998 08:34:30 Via Fax 223192 uyb19 ae03O 0

282 371 9227 July 1, 1998

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Gilead Sciences, inc. Satellite Symposium Release
Page 2 July 1,1998
The mutation associated with the use of 3TC (M184V) was detected in 76% of patients at study entry. In the
FREVEON treatment group, a mean liLY RNA change of -0.94 log10was observed at 24 weeks in patients with
the 3TC mutaion alone; -0.75 loglo in patients with the 3TC mutation and low-level AZT resistance; and w0.51
1ogzo in patients with the 3TC mtation and high level AZI? resistance. These results compare to +0.09 logo,
+0~.07 log,,, and 0.04 logs,, ies \rely, in placebo patients with the same resistance patterns. Fourteen, percent
of patints had high-levelAZ resistance mutations alone without the 3TC mutation at baseline; l'REYBON
wasnot associated with a decr~ease in HflV RNA levels in these patients.
Inedim An4 sib of Stud 411 Shows AntivairalActivIi n Treatment Naive Patients
Previously reporte data sturoxzazizng a 20 week intercim analysis of Study 411 was also presented at the
symposium. These data suggest that once-daily treatment with PREVEON in combination with other anti-lI'V
agents reduces W RNA in trea r entt'nave patients in amounts similar to changes seen in a triple-drug control
group. For example, approximately 80 percent of patints treated with one of four PREVEON consaing
combination regim for 20 weeks achieved undetectable levels of HIV RNA ( 400 ce- /mL). The media
HIV RNA decrease was 2.1 to 2.5 log,,. These data are similar to results seen in the standrd of care control
group, in which 80 percent of patients had undetectable HI V RNA levels and a median HIV RNA decree of
2.15, logs,,
Int this study, 85 patients were assigned to one of fou~r regimens containing PREVON (120 mg once per day), a
protease inhibitor (incinvir) and one or two of the following reverse transcnptae inhitbit: zidovudine
(AZiT), lamniviadine (3TC) or stavwine (d4T); the control group received AZT, 3TC and Indiriavir. The most
frequently reorted Grade 3 or 4 adverse events in this study Incuded increae in liver transamin ases
observed in 5% of patients assigned to the placebo group and S% of patients assigned to the PRBVEON
treat ga pups.
Back~groundcd 1n aon
To date, more than 5,000 paiienls have received PREVYiON uotgh clinica trials, including mope'than 3,300
through an expanded access program in the Uniuted States for patients with iied treatmnent options- Side
effects observed include changes in laboratory markers of renal function,~ dose-related gastrointestinal effects,
incudige nuse an ins o a ite an inreaesinelverthave primarilyenl anorabeens "obsmas svedsa cn patients' reelvingea obervdPRpatentONeeforg 24 weeks24 ee oro
more. In all studies, PRVEON is cowadrnistered with L-caxnitne, a dietary supplement.
Gilead Sdene is hnindepedent birophaxmaceutical company that seeks to provide accelet ted traent
solutions for patients an te pea who care for them. The Company discovers, develops and
comnmercializes roprietay therapeutics for important viral diseases, including a curetly marketed product
VISIIDE' (cicdofovir unjeion), for the treatment of CMV retinitis, a sigt trearing viral infection in patients
wit AID$ In addxt on, the Company is developing products totratdiseases caused by l-UV, eattsb
virus and influenza virus. Gilead common stock is traded on The Nasdaq Stock Market under the symbol
GULD.
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