BOSTON, MA—Patients with hepatitis C virus (HCV) infection genotype (GT) 1 with decompensated cirrhosis treated in the real world with ledipasvir/sofosbuvir plus ribavirin achieved high cure rates and comparable MELD improvement to patients in clinical trials and the ‘real-world’ setting, according to results of a study presented at The Liver Meeting® 2016.
In addition, “safety was consistent with known disease progression in this population with advanced liver disease,” stated Michael R. Charlton, MD, of the division of hepatology and liver transplantation, Intermountain Medical Center, Salt Lake City, UT.
Recently, based on the open-label SOLAR-1 and SOLAR-2 studies, the U.S. Food and Drug Administration (FDA) approved a 12-week treatment with ledipasvir/sofosbuvir (LDV/SOF) plus ribavirin (RBV) for HCV GT1 patients with decompensated cirrhosis who have limited treatment options and a poor prognosis. Guidelines released by the AASLD and IDSA also recommend this regimen as a treatment option for those who may or may not be eligible for liver transplantation.
To show generalizability of clinical trial data, Dr. Charlton and colleagues compared real-world efficacy data collected through Month 6 in Child-Pugh-Turcotte (CPT)-B and CPT-C patients from the UK expanded access program (EAP) with the two Phase 2 SOLAR studies. The UK EAP serves as a real-world dataset of comprehensive and comparable safety and efficacy data from the studied cohort, including those treated and untreated.
They found the high SVR rates overall in the SOLAR studies, 87.0%, to be comparable to rates in the UK EAP, 90.0%. In SOLAR, 9.1% of patients relapsed, as did 5.4% in the UK EAP cohort. No patients had virologic failure.
MELD improvements ≥3 at Month 6 were similar within CPT classes for SOLAR-1 and -2 and the EAP among those achieving SVR (24.0% vs. 17.0% for CPT-B and 38.0% vs. 33.0% for CPT-C, respectively).
The ledipasvir/sofosbuvir plus ribavirin was generally safe and well-tolerated, the authors concluded.
There were five deaths in the SOLAR studies, four of which occurred in patients who were CPT-C, and three deaths in the UK expanded-access program, all occurring in patients who were CPT-B. None of the deaths were attributed to treatment.
The impact of SVR and MELD improvement on long-term clinical outcomes is unknown. Direct comparison was limited due to “varying inclusion criteria among the studies from which the patients were drawn,” noted Dr. Charlton.