Abstract
Patients with hepatitis C virus (HCV) infection and cirrhosis are underrepresented in clinical trials of interferon-free regimens of direct-acting antiviral agents, making it difficult to optimize therapy. We performed a post-hoc analysis of data from seven clinical trials to evaluate the efficacy and safety of the fixed-dose combination of ledipasvir (LDV) and sofosbuvir (SOF), with and without ribavirin (RBV), in 513 treatment-naïve and previously treated patients with genotype 1 HCV and compensated cirrhosis. All patients received LDV-SOF for 12 or 24 weeks with or without RBV. We determined the rates of sustained virological response (SVR) 12 weeks after treatment (SVR12) overall and for subgroups. Of the 513 patients analyzed, 69% were previously treated and 47% had failed previous treatment with a protease-inhibitor regimen. Overall, 493 patients (96%; 95% confidence interval [CI]: 94%-98%) achieved SVR12, 98% of treatment-naïve and 95% of previously treated patients. SVR12 rates did not vary greatly by treatment duration (95% of patients receiving 12 weeks and 98% of patients receiving 24 weeks of treatment), nor by addition of RBV (95% of patients receiving LDV-SOF alone and 97% of those who received LDV-SOF plus RBV), although previously treated patients receiving 12 weeks of LDV-SOF without RBV had an SVR12 rate of 90%. One patient discontinued LDV-SOF because of an adverse event (AE). The most common AEs were headache (23%), fatigue (16%-19%), and asthenia (14%-16%). One patient (
| Original language | English |
|---|---|
| Pages (from-to) | 79-86 |
| Number of pages | 8 |
| Journal | Hepatology |
| Volume | 62 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jul 1 2015 |
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ASJC Scopus subject areas
- Hepatology
- Medicine(all)
Cite this
Ledipasvir and sofosbuvir in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis : An integrated safety and efficacy analysis. / Reddy, K. Rajender; Bourlière, Marc; Sulkowski, Mark; Omata, Masao; Zeuzem, Stefan; Feld, Jordan J.; Lawitz, Eric; Marcellin, Patrick; Welzel, Tania M.; Hyland, Robert; Ding, Xiao; Yang, Jenny; Knox, Steven; Pang, Phillip; Dvory-Sobol, Hadas; Subramanian, G. Mani; Symonds, William; Mchutchison, John G.; Mangia, Alessandra; Gane, Edward; Mizokami, Masashi; Pol, Stanislas; Afdhal, Nezam.
In: Hepatology, Vol. 62, No. 1, 01.07.2015, p. 79-86.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Ledipasvir and sofosbuvir in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis
T2 - An integrated safety and efficacy analysis
AU - Reddy, K. Rajender
AU - Bourlière, Marc
AU - Sulkowski, Mark
AU - Omata, Masao
AU - Zeuzem, Stefan
AU - Feld, Jordan J.
AU - Lawitz, Eric
AU - Marcellin, Patrick
AU - Welzel, Tania M.
AU - Hyland, Robert
AU - Ding, Xiao
AU - Yang, Jenny
AU - Knox, Steven
AU - Pang, Phillip
AU - Dvory-Sobol, Hadas
AU - Subramanian, G. Mani
AU - Symonds, William
AU - Mchutchison, John G.
AU - Mangia, Alessandra
AU - Gane, Edward
AU - Mizokami, Masashi
AU - Pol, Stanislas
AU - Afdhal, Nezam
PY - 2015/7/1
Y1 - 2015/7/1
N2 - Patients with hepatitis C virus (HCV) infection and cirrhosis are underrepresented in clinical trials of interferon-free regimens of direct-acting antiviral agents, making it difficult to optimize therapy. We performed a post-hoc analysis of data from seven clinical trials to evaluate the efficacy and safety of the fixed-dose combination of ledipasvir (LDV) and sofosbuvir (SOF), with and without ribavirin (RBV), in 513 treatment-naïve and previously treated patients with genotype 1 HCV and compensated cirrhosis. All patients received LDV-SOF for 12 or 24 weeks with or without RBV. We determined the rates of sustained virological response (SVR) 12 weeks after treatment (SVR12) overall and for subgroups. Of the 513 patients analyzed, 69% were previously treated and 47% had failed previous treatment with a protease-inhibitor regimen. Overall, 493 patients (96%; 95% confidence interval [CI]: 94%-98%) achieved SVR12, 98% of treatment-naïve and 95% of previously treated patients. SVR12 rates did not vary greatly by treatment duration (95% of patients receiving 12 weeks and 98% of patients receiving 24 weeks of treatment), nor by addition of RBV (95% of patients receiving LDV-SOF alone and 97% of those who received LDV-SOF plus RBV), although previously treated patients receiving 12 weeks of LDV-SOF without RBV had an SVR12 rate of 90%. One patient discontinued LDV-SOF because of an adverse event (AE). The most common AEs were headache (23%), fatigue (16%-19%), and asthenia (14%-16%). One patient (
AB - Patients with hepatitis C virus (HCV) infection and cirrhosis are underrepresented in clinical trials of interferon-free regimens of direct-acting antiviral agents, making it difficult to optimize therapy. We performed a post-hoc analysis of data from seven clinical trials to evaluate the efficacy and safety of the fixed-dose combination of ledipasvir (LDV) and sofosbuvir (SOF), with and without ribavirin (RBV), in 513 treatment-naïve and previously treated patients with genotype 1 HCV and compensated cirrhosis. All patients received LDV-SOF for 12 or 24 weeks with or without RBV. We determined the rates of sustained virological response (SVR) 12 weeks after treatment (SVR12) overall and for subgroups. Of the 513 patients analyzed, 69% were previously treated and 47% had failed previous treatment with a protease-inhibitor regimen. Overall, 493 patients (96%; 95% confidence interval [CI]: 94%-98%) achieved SVR12, 98% of treatment-naïve and 95% of previously treated patients. SVR12 rates did not vary greatly by treatment duration (95% of patients receiving 12 weeks and 98% of patients receiving 24 weeks of treatment), nor by addition of RBV (95% of patients receiving LDV-SOF alone and 97% of those who received LDV-SOF plus RBV), although previously treated patients receiving 12 weeks of LDV-SOF without RBV had an SVR12 rate of 90%. One patient discontinued LDV-SOF because of an adverse event (AE). The most common AEs were headache (23%), fatigue (16%-19%), and asthenia (14%-16%). One patient (
UR - http://www.scopus.com/inward/record.url?scp=84933181270&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84933181270&partnerID=8YFLogxK
U2 - 10.1002/hep.27826
DO - 10.1002/hep.27826
M3 - Article
C2 - 25846144
AN - SCOPUS:84933181270
VL - 62
SP - 79
EP - 86
JO - Hepatology
JF - Hepatology
SN - 0270-9139
IS - 1
ER -