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Author Topic: GS-9350  (Read 1624 times)

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Offline John2038

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« on: January 06, 2010, 01:52:54 AM »
Pharmacokinetics and Pharmacodynamics of GS-9350: A Novel Pharmacokinetic Enhancer Without Anti-HIV Activity

GS-9350 is a new chemical entity under development as a potent, mechanism-based inhibitor of human cytochrome P450 3A (CYP3A) isoforms. Its intended use is to increase the systemic exposure of coadministered agents that are metabolized by CYP3A enzymes. Unlike ritonavir, which is in current clinical use for this purpose, GS-9350 is devoid of anti-HIV activity. The pharmacokinetics of GS-9350 and its efficacy in increasing systemic exposure of the probe CYP3A substrate midazolam were examined in a study involving single- and multiple-dose escalations of GS-9350 from 50 to 400 mg. Single-dose escalation from 50 to 400 mg resulted in a 164-fold increase in GS-9350 exposure, whereas multiple-dose escalation in the dosage range of 50-300 mg resulted in a 47-fold increase in exposure. GS-9350 potently inhibited midazolam apparent clearance (95% reduction), similar in effect to ritonavir 100 mg. GS-9350 was generally well tolerated at all doses, and there was no evidence of dose-limiting toxicity. Establishing proof-of-concept, GS-9350 is currently under phase II development as a potential alternative to ritonavir for use with antiretroviral agents (including the HIV integrase inhibitor elvitegravir) that are often prescribed along with a "booster" drug.


Offline esper

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Re: GS-9350
« Reply #1 on: January 06, 2010, 08:49:43 PM »
Hi John, I saw this news today from Gilead referencing the  GS-9350 so thought I'd post it here as well. Veritas had posted something about Gilead's "Quad" pill entering phase II trials a few months back so I posted the latest news there. The results they published today look very good. Anyway, here's the link.....

Phase II Clinical Trial of Gilead's Investigational Integrase-Based, Once-Daily, Fixed-Dose "Quad" Regimen Meets 24-Week Primary Objective - 24-Week Data from a Second Phase II Study Supports GS 9350 as an Effective Boosting Agent

edited for spelling/grammar
« Last Edit: January 06, 2010, 10:22:38 PM by esper »
tested positive June 26, 2009
06/26/2009-CD4 428: VL 56,200: 34.1%
09/28/2009-CD4 388: VL 105,000: 31.9%
11/16/2009-CD4 330: VL 242,000: 23.4%
12/11/09 started stocrin (sustiva) & truvada
02/02/2010-CD4 588: VL 204: 31.6%
04/27/2010-CD4 620; VL 154; 38.5%
08/25/2010-CD4 504; VL undet; 39.2%
11/16/2010-CD4 499: VL undet: 44.6%
03/01/2011-CD4 534: VL undet: 33.2%
06/01/2011-CD4 709: VL undet: 45.6%
12/11/2011-CD4 537: VL undet: 41.5%
06/10/2012-CD4 597: VL undet: 42.8%
Switched to Atripla 12/2012.
Latest 09/2015-CD4 816: VL undet: 49.2%


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