Does a Detectable Viral Load During Hepatitis C Treatment at Week 4 Predict Virologic Failure in an 8-Week Course of Ledipasvir-Sofosbuvir in Treatment-Naïve Patients with Genotype 1 Infection without Cirrhosis?

Background: Treatment of hepatitis C virus (HCV) with a shorter duration of 8 weeks of ledipasvir-sofosbuvir has resulted in high rates of sustained virologic response (SVR) similar to a 12-week duration in treatment-naïve patients with genotype 1 infection without cirrhosis. This treatment strategy yields the opportunity to significantly reduce healthcare costs and associated adverse effects. The objective of this study is to assess if a detectable viral load at Week 4 predicts failure for an 8-week course of ledipasvir-sofosbuvir.

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.