Methods: A retrospective, quality assurance chart review was conducted at the W.G. (Bill) Hefner VA Medical Center in Salisbury, North Carolina, where 333 patients have completed a HCV treatment course of ledipasvir-sofosbuvir from January 2015 to May 2016. Treatment-naïve, HCV genotype 1 patients without cirrhosis who received 8 weeks of ledipasvir-sofosbuvir were assessed. The association between SVR and detectable HCV viral loads at Week 4 of treatment using COBAS AMPLIPREP/TaqMan with a lower limit of quantification of 15 international units (IU) per milliliter was evaluated.
Results: Overall, 38 of 44 patients (86.4%) of patients receiving 8 weeks of ledipasvir-sofosbuvir achieved SVR. Of the 38 patients that achieved SVR, 30 (78.9%) patients had nondetectable viral loads at Week 4 of treatment whereas 8 patients (21.1%) had a detectable viral load at week 4 (p = 0.96). For the 5 patients that relapsed on 8 weeks of ledipasvir-sofosbuvir, 4 patients (80%) had nondetectable viral loads at Week 4 of treatment whereas 1 patient (20%) had a detectable viral load at Week 4.
Conclusion: Detectable viral loads at week 4 do not appear to negatively impact SVR in treatment-naïve, HCV genotype 1 patients without cirrhosis treated with 8 weeks of ledipasvir-sofosbuvir. Additionally, relapse is possible despite nondetectable viral loads during treatment.
H. Bajillan, None
J. Sanders, None