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The ION-4 study analyzed the efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) in the HIV/HCV co-infected population. Permitted concomitant ARVs included raltegravir (RAL), efavirenz and rilpivirine, with a NRTI backbone of emtricitabine/tenofovir (FTC/TDF). The primary efficacy endpoint was SVR12.
Results showed that 97% of subjects taking RAL + TDF/FTC (n=146) achieved SVR12. No patient had confirmed HIV virologic rebound (HIV RNA of 400 copies/ml or more) and none discontinued study drug due to adverse effects. Additionally, no significant lab abnormalities were observed.
The manufacturer for LDV/SOF states that there is no clinically significant interaction with RAL and these agents may be co-administered.
Naggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ, Gane E. Ledipasvir and sofosbuvir for hcv in patients coinfected with hiv-1. New England Journal Of Medicine. 2015; 8: 705-713.