Real-world outcomes of ledipasvir/sofosbuvir in treatment-naive patients with hepatitis C.
OBJECTIVE
Studies of hepatitis C virus (HCV) regimens have documented substantially reduced effectiveness in sustained virologic response (SVR) in the context of real-world clinical practice compared with clinical trials. Real-world and clinical trial SVR and cost-per-SVR data have not been reported for the all-oral, peginterferon-free and ribavirin (RBV)-free ledipasvir/sofosbuvir (LDV/SOF) regimen. Our objective was to compare the rates of SVR achievement and cost per SVR between pooled data from clinical studies of LDV/SOF and from real-world clinical practice.


METHODS
Data were derived from the Hepatitis C Therapeutic Registry and Research Network (HCV-TARGET), a real-world, multicenter, prospective, observational study; and from the TRIO Network, a retrospective database of HCV-treated patients. The 1-year cost per SVR was calculated as the total cost of an SVR ([cost of treatment regimen, adverse events, and monitoring costs] per SVR) during the first year of treatment.


RESULTS
After 12 weeks, the SVR rates obtained in real-world studies ranged from 94% to 98%, comparing favorably with the SVRs achieved in the ION-1 and ION-3 trials (94% and 95%-99% with 8 and 12 weeks of RBV-free therapy, respectively). A single SVR, on average, cost $84,989 among patients enrolled in the ION-3 trial, with higher costs ($101,204) among patients with compensated cirrhosis compared with noncirrhotic patients ($81,668). In the pooled TARGET/TRIO population, the average cost of an SVR was $84,770, with costs of $101,380 and $81,368 in patients with compensated cirrhosis and patients without cirrhosis, respectively.


CONCLUSIONS
Unlike the results obtained with prior HCV regimens, this study suggests that similar SVR rates are achieved with LDV/SOF in clinical trial-based studies and real-world studies. Further, achieving an SVR in real-world clinical practice was not associated with excess costs.
Zobair M
ZM
Younossi
Haesuk
H
Park
Staurt C
SC
Gordon
John R
JR
Ferguson
Aijaz
A
Ahmed
Douglas
D
Dieterich
Beatty Center for Integrated Research, 3300 Gallows Road, Falls Church, VA 22042. E-mail: zobair.younossi@inova.org.
Sammy
S
Saab
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use; D001562:Benzimidazoles / Q000191:economics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D005260:Female; D005449:Fluorenes / Q000191:economics / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics / Q000453:epidemiology; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data; D011446:Prospective Studies; D012042:Registries; D000069474:Sofosbuvir; D000072230:Sustained Virologic Response; D014481:United States / Q000453:epidemiology; D014542:Uridine Monophosphate / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D055815:Young Adult
D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C000595958:ledipasvir, sofosbuvir drug combination; D014542:Uridine Monophosphate; D000069474:Sofosbuvir