A	B	C	D	E
1	Main
2		Brand Name	GS7977
3		Generic Name	sofosbuvir
4		Class	uridine nuclotide analog
5		Clinical Trials
6			Phase 2 Electron
7			randomized, open label
8			4 treatment arms. GS-7977 400mg QD
9
10			n=10, treatment naïve, non cirrhotic with HCV2 or HCV3. PSI-7977 + PEG/RBV for 8 weeks
11				4/19/12 EASL
12				Baseline HCV RNA 6.1log10
13				all 10 achieved HCV RNA <LOD by week 2 and <LOD through week 8
14				7/7 subjects remain HCV RNA <LOD 2 weeks into follow up
15				5/5 to date have SVR4
16			n=10, previous null responders (previous IFN failures), HCV1, PSI-7977/RBV for 12 weeks
17				2/17/12 PR	8/10 patients in HCV1 relapsed within 4 weeks of completing 12 week treatment. 2 did not relapse but have only reached 2 weeks post treatment time point.
18					This was the prior "null" to an IFN treatment regimen arm
19				4/19/12 EASL
20				enrolled 9 prior null responders with GT1, BL HCV RNA 6.0log10 IU/mL
21				7/9 had HCV RNA <LOD by week 2
22			n=25, prior non-responders, HCV2/HCV3, PSI-7977/RBV for 12 weeks
23			n=25, treatment naïve, non-cirrhotic, HCV1, PSI-7977/RBV for 12 weeks.
24				4/19/12 EASL. Poster 1113
25				HCV1 Naïve. 88% (n=22/25) remained HCV RNA undetectable 4 weeks after completion (SVR4). 3 experienced relapse
26
27
28
29
30
31
32			Phase 2b QUANTUM
33
34			studied for 12 and 24 weeks
35				4 arms
36				938 alone (300mg QD). Stopped
37				938 (300mg QD) and 7977 (400mg QD). Stopped
38				7977 (400mg QD) and ribavarin
39				938 (300mg QD), 7977 (400mg QD) and ribavarin. Stopped
40			placebo studied for 24 weeks
41			12/16/11 PR
42			Amended the design of trial. Discontinuing all 938 treatment arms. 235 patients were receiving the drug.
43			Abnormalities with liver function detected in 938 (300mg QD) patients
44
45			7977 + ribavarin for 24 weeks
46			Genotypes 1, 2, 3
47				Schoenebaum poll of 204 WS investors sugests 62% SVR4 for HCV1 patients.
48
49			Phase 2 ATOMIC
50			n=316. non-cirrhotic and had HCV RNA of at least 50,000 IU/mL.
51				11 patients had GT4
52				5 patients with GT6
53				mean age of 50 yrs
54				mean BMI of 28. 65% male, 10% black, 20% hispanic
55				mean baseline HGV RNA 6.4log10 IU/ml and 18% of subjects have IL28B genotype TT
56			GS-7977 (400mg QD) + IFN (180ug weekly injection) + RBV (500mg BID) in HCV1 naïve
57			randomized 1:2:3
58			n=52 for 12 weeks
59			n=109 for 24 weeks (16 of these were HCV4/HCV6 genotype)
60			n=155 for 12 weeks followed by re-randomization (1:1) to receive additional 12 weeks of either GS-7977 alone or GS-7977 + RBV
61			Patients in all arms will be followed to determine their 12 & 24 weeks SVR.
62
63				4/19/2012 Press release. n=52 for 12 weeks data
64				SVR12 of 90% (n=47/52). Undetectable viral load (HCV RNA <25 IU/ml) at 12 weeks post completion of therapy
65				one patient lost to follow up
66				at end of treatment 51/51 were HCV RNA undetectable
67				at 12 weeks post treatment completion, 50/51 patients were available for follow up
68				47/50 (94%) remained HCV RNA undetectable
69				3 patients relapsed
70				At abstract submission, all subjects have received >= 8 weeks of 7977.