Safety and efficacy of simeprevir plus sofosbuvir with or without ribavirin in patients with decompensated genotype 1 hepatitis C cirrhosis.
Combination antiviral therapy involving sofosbuvir (SOF) and simeprevir (SIM) is a treatment option in patients with genotype 1 chronic hepatitis C; however, the safety of this regimen in patients with decompensated cirrhosis is not established. Data from a combined treatment cohort of 2 large hepatology referral centers were evaluated to assess for safety and efficacy of SIM plus SOF with or without ribavirin (RBV) in patients with Child B or C cirrhosis. All (n = 42) patients included in the analysis had Child B (n = 35) or C (n = 7) cirrhosis and received 400 mg daily of SOF plus 150 mg daily of SIM, with (n = 7) or without (n = 35) RBV, for 12 weeks. Of the 42 patients in this cohort, 31 (74%) were male, 22 (52%) had failed prior treatments, and 28 (67%) were genotype 1a. Prior decompensating events included encephalopathy (57%), fluid overload (88%), or variceal hemorrhage (24%). Median Model for End-Stage Liver Disease score was 12 (range, 6-25). Treatment was well tolerated overall with more than one-half (57%) reporting no adverse events. In those reporting adverse events, the most common were fatigue (n = 6), insomnia (n = 4), headache (n = 5), nausea (n = 4), and grade 1 rash (n = 1). One patient developed chemical pancreatitis that did not require treatment discontinuation. Three of 7 patients who received RBV developed anemia, with 2 requiring blood transfusions and 1 requiring a dose reduction. No episodes of decompensation requiring hospitalization or deaths occurred on treatment. Of 42 patients, 38 (90%) patients had negative viral load at end of treatment (EOT), and 31 of 42 patients (74%) achieved sustained virological response 12 weeks after EOT; 10 of 10 patients (100%) with HCV genotype 1b achieved sustained virological response for 12 weeks (SVR12). In conclusion, SOF plus SIM was very well tolerated in patients with advanced Child B/C decompensated cirrhosis. Overall, 74% of patients achieved SVR12; 100% of patients with genotype 1b decompensated cirrhosis achieved SVR12.
Liver Consultants of Texas, Baylor Simmons Transplant Center, Fort Worth, TX.
Apurva A
AA
Modi
Liver Institute, Methodist Dallas Medical Center, Dallas, TX.
Hector
H
Nazario
Liver Consultants of Texas, Baylor Simmons Transplant Center, Fort Worth, TX.
James F
JF
Trotter
Liver Consultants of Texas, Baylor Simmons Transplant Center, Fort Worth, TX.
Manjushree
M
Gautam
Liver Institute, Methodist Dallas Medical Center, Dallas, TX.
Jeffrey
J
Weinstein
Liver Institute, Methodist Dallas Medical Center, Dallas, TX.
Parvez
P
Mantry
Liver Institute, Methodist Dallas Medical Center, Dallas, TX.
Maisha
M
Barnes
Liver Institute, Methodist Dallas Medical Center, Dallas, TX.
Adil
A
Habib
Liver Consultants of Texas, Baylor Simmons Transplant Center, Fort Worth, TX.
Jean
J
McAfee
Liver Institute, Methodist Dallas Medical Center, Dallas, TX.
Olga
O
Teachenor
Liver Institute, Methodist Dallas Medical Center, Dallas, TX.
Lauren
L
Tujague
Liver Consultants of Texas, Baylor Simmons Transplant Center, Fort Worth, TX.
Stevan
S
Gonzalez
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D019698:Hepatitis C, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006518:Hepatitis Viruses / Q000187:drug effects* / Q000235:genetics; D006801:Humans; D008103:Liver Cirrhosis / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D000069616:Simeprevir / Q000009:adverse effects / Q000627:therapeutic use*; D000069474:Sofosbuvir / Q000009:adverse effects / Q000627:therapeutic use*; D013781:Texas; D013997:Time Factors; D016896:Treatment Outcome
D000998:Antiviral Agents; D012254:Ribavirin; D000069616:Simeprevir; D000069474:Sofosbuvir