William F. Balistreri, MD


March 22, 2016

In This Article

Treatment-Naive Patients Without Cirrhosis and With HCV Genotype 1

The current recommendation[2] for therapy in treatment-naive patients without cirrhosis who are infected with HCV genotype 1 is 12 weeks of LDV/SOF. However, patients with baseline HCV RNA levels < 6 million IU/mL may be treated for 8 weeks.

Curry and colleagues[3] set out to determine whether there is noninferiority between these two regimens, either in clinical trials or in a real-world population. They obtained data from specialty pharmacies for 510 treatment-naive patients with HCV genotype 1 who initiated treatment with LDV/SOF for either 8 or 12 weeks. An examination of this real-world heterogeneous hepatitis C population revealed a preference by prescribing physicians for 12 weeks of treatment even when baseline HCV RNA levels were < 6 million IU/mL, despite guidelines suggesting a shorter 8-week treatment duration.

Di Martino and colleagues[4] reviewed all phase 2 and phase 3 trials that compared 8 vs 12 weeks of treatment with any DAA in noncirrhotic, treatment-naive patients with HCV genotype 1. Overall, a sustained viral response (SVR) was obtained in 93% of patients after 12 weeks of treatment that included RBV, 96% of those after 12 weeks of treatment without RBV, 92% of those treated for 8 weeks with RBV, and 92% of those treated for 8 weeks without RBV. Regardless of the use of RBV, treatment of 12 weeks' duration was associated with higher SVR rates.

Patients with HCV genotype 1 may experience virologic relapse after treatment with the all-oral regimen of SMV and SOF. Therefore, the efficacy and safety of treating patients with relapse using a LDV/SOF fixed-dose combination with or without RBV was investigated by Pungpapong and colleagues.[5] All patients who received treatment for at least 4 weeks achieved undetectable HCV RNA at a median of 4 weeks and remained negative thereafter.


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