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Time-weighted average viral load from baseline through day 14 declined by 0.54 log for TDF, compared to 0.95 log for 50 mg GS-7340 and 1.07 log for 150 mg GS-7340. | |
At14 days, the mean decrease in HIV viral load was 0.94 log for TDF, compared to 1.57 log for 50mg GS-7340 and 1.71 log for 150 mg GS-7340. | |
There were no serious adverse effects in any arm of the study. | |
Headache was the most commonly reported side effect. | |
There were no significant laboratory abnormalities in any arm of the study. | |
The 2 doses of GS-7340 reached higher drug concentrations in PBMCs compared to plasma. | |
In contrast, TDF reached higher levels in plasma. |
Countries of recruitment: | Australia |
Postcode: | 6009, 3181 |
| Outside Australia |
| United Kingdom - London |
| United Kingdom - Birmingham |
| United Kingdom - Nottingham |
| Canada - British Columbia |
| Canada - Ontario |
| Canada - Quebec |
| Canada - Alberta |
| New Zealand - Auckland |
Brief summary: | This is a randomized, open-label, active-controlled study whose primary objective is to evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the safety, viral kinetics, and antiviral activity of each of four doses of GS-7340 over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of GS-7340 versus TDF 300-mg over 28 days of therapy. Approximately 50 eligible subjects with chronic HBV infection who are naïve to anti-HBV treatment will be randomized 1:1:1:1:1 to receive treatment with GS-7340 8-, 25-, 40-, or 120-mg or TDF 300-mg orally once daily. Subjects may be HBeAg+ or HBeAg-. Enrollment will be stratified by HBeAg status with approximately a 1:1 distribution resulting in approximately 25 HBeAg+ and 25 HBeAg- subjects. All subjects must be followed for safety for 30 days after the 28-day treatment. Optional blood samples may be obtained for exploratory biomarker and pharmacogenomic discovery research at any time during the study or at a separate post study visit, if necessary. Subjects who agree to have blood drawn for pharmacogenomic research will sign a separate informed consent form. |
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