Ledipasvir/Sofosbuvir Effective in HCV Mono- and HCV/HIV Coinfected Patients
SAN DIEGO, CA—Once-daily single-tablet ledipasvir/sofosbuvir (LDV/SOF) provided high rates of sustained virologic response (SVR) at Week 12 in both patients with hepatitis C virus (HCV) mono-infection and HIV/HCV coinfection, according to results of a pooled analysis presented at IDWeek 2015.
The analysis compared the safety and efficacy of LDV/SOF at Week 12 (SVR12) in patients with HCV GT 1 coinfected with HIV-1 in the Phase 3 ION 4 study, with patients monoinfected with HCV GT 1 in the phase 3 ION 1, ION 2, and ION 3 studies.
“Efficacy rates with 12 weeks LDV/SOF in HIV/HCV coinfected patients were similar to those seen in HCV monoinfected patients” (SVR12 96% vs. 97%), reported lead study author Susanna Naggie, MD, MHS, of Infectious Diseases Research at Duke Clinical Research Institute in Durham, North Carolina. “LDV/SOF represents a highly effective treatment option for patients with HIV/HCV coinfection and HCV monoinfection.”
Neither prior HCV treatment status nor cirrhosis affected outcomes, Dr. Naggie noted.
Four patients in ION 4 failed to achieve SVR12, due to breakthrough in two cases, the loss of one patient to follow-up, and the death of another patient, Dr. Naggie reported.
The LDV/SOF regimen's safety profile in HIV/HCV-coinfected patients was also similar to that seen in HCV monoinfected patients, and HIV disease status and treatment had “no adverse impact” on LDV/SOF safety, she noted. One patient in ION 4, died.
No patients discontinued treatment due to adverse events (AEs) in ION 4 and less than 1% of monoinfected patients in previous ION trials, had to discontinue treatment due to AEs. The most common AEs (any grade) at Week 12 in ION 4 were fatigue (21%), headache (25%), diarrhea (11%) and nausea (10%), Dr. Naggie reported.