Replies to post #1737 on Idenix Pharmaceuticals (IDIX)

[DewDiligence]

Baraclude Studies in Progress

[Studies sponsored by BMY except as noted.]


First-line setting

Baraclude vs Tyzeka 12-week PK study in Korea
(sponsored by NVS/IDIX, 40 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00412529
Open-label extension of above trial out to 2 years (recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00467545

Baraclude vs Hepsera
(52 patients, fully enrolled)
http://www.clinicaltrials.gov/ct/show/NCT00096785

Baraclude +/- Viread
(384 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00410072


Second-line setting

3-arm study in Lamivudine-refractory patients.
Arm A: Baraclude + Hepsera
Arm B: Baraclude monotherapy
Arm C: Hepsera monotherapy
(420 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00410202


Miscellaneous settings

Baraclude vs Hepsera in decompensated liver disease
(220 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00065507

Baraclude vs Viread/Truvada in decompensated liver disease.
Arm A: Viread
Arm B: Truvada
Arm C: Baraclude
(sponsored by GILD, 100 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00298363

Single–arm study of Baraclude monotherapy in patients receiving liver transplant
(70 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00395018

Single-arm study of Baraclude in first-line black/Hispanic patients
(80 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00371150

Long-term longitudinal study of Baraclude vs “physician’s choice” monotherapy
(12,500 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00388674

[DewDiligence]

Viread / Truvada HBV Studies in Progress

[Excludes the large number of trials in HIV/HBV co-infected
patients. Studies sponsored by GILD except as noted. ]


First-line setting

Baraclude +/- Viread
(sponsored by BMY, 384 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00410072

Viread vs Truvada
(100 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00507507


Second-line setting

Viread vs Truvada in poor responders to Hepsera
(90 patients, enrollment complete):
http://www.clinicaltrials.gov/ct/show/NCT00307489

3-arm study in poor responders to Hepsera.
Arm A: Tyzeka + Hepsera
Arm B: Tyzeka + Viread
Arm C: Continued Hepsera monotherapy
(sponsored by NVS/IDIX, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00409019


Miscellaneous settings

Baraclude vs Viread/Truvada in decompensated liver disease.
Arm A: Viread
Arm B: Truvada
Arm C: Baraclude
(100 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00298363

Truvada +/- Hepatitis B Immunoglobulin in patients with liver transplant
(50 patients, not yet recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00507689

[DewDiligence]

Tyzeka Studies in Progress

[Updated for discontinuation of Valtorcitabine
program. All studies sponsored by NVS/IDIX.
Also see #msg-22372270.]


First-line setting

Tyzeka vs Baraclude 12-week PK study in Korea
(40 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00412529
Open-label extension of above trial out to 2 years (recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00467545

Tyzeka vs Hepsera in e-positive patients
(120 patients, fully enrolled):
http://www.clinicaltrials.gov/ct/show/NCT00115245
Note: Data from first year reported in #msg-21746191 (scan halfway down).

3-arm trial in e-positive patients.
Arm A: Tyzeka + Pegasys
Arm B: Tyzeka monotherapy
Arm C: Pegasys monotherapy
(300 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00412750


Second-line setting

3-arm trial in poor responders to Hepsera.
Arm A: Tyzeka + Hepsera
Arm B: Tyzeka + Viread
Arm C: Continued Hepsera monotherapy
(recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00409019

Hepsera +/- Tyzeka in Lamivudine-resistant patients
(60-120 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00376259

Tyzeka vs (continued) Lamivudine following first-line Lamivudine
(240 patients, fully enrolled):
http://www.clinicaltrials.gov/ct/show/NCT00132652


Miscellaneous settings

Tyzeka vs Lamivudine in decompensated liver failure
(240 patients, more than 50% enrolled):
http://www.clinicaltrials.gov/ct/show/NCT00076336