BOSTON, MA—Real-world effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in patients coinfected with HIV and HCV correlates closely with data observed in clinical trials, an analysis presented at The Liver Meeting® 2016 has shown.

These results confirm that high rates of sustained virologic response (SVR) from real-world cohorts are generalizable from clinical trials, including among patients who are black and treatment-experienced with cirrhosis, noted Susanna Naggie, MD, of Duke University in Durham, NC. “The results support both the EASL and AASLD/IDSA guidelines which recommend LDV/SOF regimens for HIV/HCV coinfected patients.”

The study’s goal was to compare real-world and clinical-trial single-tablet ledipasvir/sofosbuvir regimen efficacy in patients with HCV genotype 1 and HIV co-infection. 

The investigators compared data from three clinical trials of ledipasvir/sofosbuvir in HIV/HCV co-infected patients—ERADICATE, ION-4, and ANRS HC31 SOFTRIH—to four real world cohorts, selected based on willingness to participate. Each cohort had at least 50 HIV/HCV co-infected patients from HCV-TRIO, ASCEND, Portugal, and U.S. Veterans Affairs (USC), representing “diverse patient populations from Europe and U.S. including academic centers, urban primary care settings, and the Veterans Health Administration,” Dr. Naggie noted. 

The clinical trials enrolled 453 patients in all. None of the 50 patients in ERADICATE had cirrhosis, while 20% of ION 4’s 335 patients and 40% of ANRS’s 68 patients, had cirrhosis.

Patients were treated with 12 or 24 weeks of ledipasvir/sofosbuvir and had an overall SVR12 rate of 97%. By individual clinical trial, SVR12 rates were 98% (49 of 50 patients) for ERADICATE, 96% (314 of 347) for ION-4, and 100% (65 of 65) for SOFTRIH (3 patients were not evaluable for virological efficacy). 

The real world cohort studies enrolled 1,231 patients. Between 20% and 35% of patients in the four cohort studies had cirrhosis. Patients were treated with 8, 12, or 24 weeks of ledipasvir/sofosbuvir with or without ribavirin. 

Overall, SVR12 rates for patients with GT1 HCV were 97% for clinical trials and 94% for real-world cohorts. Subgroup analyses showed clinical trial and real-world cohort SVR12 rates to be 93% vs. 92% for black people, 98% vs. 97% among treatment-experienced patients, and 96% vs 94% among cirrhotic patients.

Among patients with HIV/HCV GT1 co-infection treated with LDV/SOF, SVR12 rates ranged from 96% to 100%, compared to 91% to 98% in the real-world cohorts.