Hepati tis web study Hepati tis web study Sofosbuvir-Ledipasvir +/- Ribavirin in GT-1 LONESTAR Trial Phase 2a Treatment Naïve and Treatment Experienced Source: Lawitz E, et al. Lancet. 2014:383:515-23.
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Hepatitisweb study
Hepatitisweb study
Sofosbuvir-Ledipasvir +/- Ribavirin in GT-1LONESTAR Trial
Phase 2a
Treatment Naïve and Treatment Experienced
Source: Lawitz E, et al. Lancet. 2014:383:515-23.
Hepatitisweb studySource: Lawitz E, et al. Lancet. 2014:383:515-23.
Ledipasvir-Sofosbuvir +/- Ribavirin in Naïve & Experienced GT1LONESTAR Trial: Features
LONESTAR Trial
Design: Open-label, phase 2, using fixed dose combination of ledipasvir-sofosbuvir +/- ribavirin in treatment-naïve and treatment-experienced GT 1
Setting: one center in USA (San Antonio, Texas)
Entry Criteria - Chronic HCV Genotype 1- Cohort A: Treatment-naïve - Cohort B: Prior virologic failure with protease inhibitor regimen
Patient Characteristics (range in different treatment arms)- N = 100 adult patients - Treatment-Naive: none with cirrhosis- Previously Treated: approximately 55% with cirrhosis- Previously Treated: approximately 2/3 non-responders and 1/3 relapsers- IL28B Genotype: non-CC (range of 67-95%)
End-Points: Primary = SVR12; safety and tolerability
Hepatitisweb studySource: Lawitz E, et al. Lancet. 2014:383:515-23.
Ledipasvir-Sofosbuvir +/- Ribavirin in Naïve & Experienced GT1LONESTAR: Study Design
Week 0 248 12 20
Abbreviations: LDV-SOF= ledipasvir-sofosbuvir; RBV = ribavirin
Drug DosingLedipasvir-Sofosbuvir: 90/400 mg fixed dose combination one pill once dailyRibavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg
LDV-SOF SVR12Cohort A
Naïven=60
n = 21
n = 20
LDV-SOF + RBV
n = 19 LDV-SOF
SVR12
SVR12
Cohort BExperienced
n=40
n = 19 LDV-SOF SVR12
n = 21 LDV-SOF + RBV SVR12
Hepatitisweb study
Ledipasvir-Sofosbuvir +/- Ribavirin in Naïve & Experienced GT1LONESTAR Trial: Results
LONESTAR: SVR 12, by Cohort and Treatment Regimen
Source: Lawitz E, et al. Lancet. 2014:383:515-23.
LDV-SOF _x000d_x 8 wks
LDV-SOF + RBV _x000d_x 8 wks
LDV-SOF _x000d_x 12
wks
LDV-SOF _x000d_x 12
wks
LDV-SOF+ RBV _x000d_x 12
wks
0
20
40
60
80
100
95100
95 95100
Pat
ien
ts w
ith
SV
R (
%)
*One patient lost to follow-up; LDV-SOF = ledipasvir-sofosbuvir; RBV = ribavirin; PI = protease inhibitor
19/20
Cohort A: Treatment-Naive Cohort B: Experienced (with PI)
21/21 18*/19 21/2118/19
Hepatitisweb studySource: Lawitz E, et al. Lancet. 2014:383:515-23.
Adverse Event(AE)
Cohort A Cohort B
LDV-SOF x 8 weeks
(n=20)
LDV-SOF + RBV
x 8 weeks(n=21)
LDV-SOF x 12 weeks
(n=19)
LDV-SOF x 12 weeks
(n=19)
LDV-SOF + RBVx 12 weeks
(n=21)
Serious AE 0 (0%) 1 (5%) 1 (5%) 1 (5%) 1 (5%)
Nausea 2 (10%) 2 (10%) 1 (5%) 0 (0%) 4 (19%)
Anemia 0 (0%) 2 (10%) 0 (0%) 0 (0%) 6 (29%)
Upper RTI 2 (10%) 0 (0%) 1 (5%) 1 (5%) 4 (19%)
Headache 2 (10%) 3 (14%) 0 (0%) 1 (5%) 1 (5%)
Abdominal pain 1 (5%) 1 (5%) 1 (5%) 0 (0%) 1 (5%)
Bronchitis 1 (5%) 1 (5%) 0 (0%) 1 (5%) 1 (5%)
Back pain 1 (5%) 1 (5%) 1 (5%) 1 (5%) 0 (0%)
Decreased appetite 0 (0%) 2 (10%) 0 (0%) 1 (5%) 0 (0%)
Dermatitis 1 (5%) 0 (0%) 0 (0%) 0 (0%) 2 (10%)
Muscle spasms 1 (5%) 0 (0%) 0 (0%) 0 (0%) 2 (10%)
Ledipasvir-Sofosbuvir +/- Ribavirin in Naïve & Experienced GT1LONESTAR Trial: Adverse Events
Hepatitisweb studySource: Lawitz E, et al. Lancet. 2014:383:515-23.
Ledipasvir-Sofosbuvir +/- Ribavirin in Naïve & Experienced GT1LONESTAR Trial: Conclusion
Interpretation: “These findings suggest that the fixed-dose combination
of sofosbuvir-ledipasvir alone or with ribavirin has the potential to cure
most patients with genotype-1 HCV, irrespective of treatment history or
the presence of compensated cirrhosis. Further clinical trials are needed
to establish the best treatment duration and to further assess the
contribution of ribavirin.”
Hepatitisweb study
Hepatitisweb study
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects.
Hepatitis C Online
www.hepatitisc.uw.edu
Hepatitis Web Study
http://depts.washington.edu/hepstudy/
Funded by a grant from the Centers for Disease Control and Prevention.
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