Source: GS-007 ENDURANCE-3: safety and efficacy of glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in treatment-naïve HCV genotype 3-infected patients without cirrhosis—G. R. Foster et al.
Study Aims and Results: The aim of the ENDURANCE -3 study was three-fold—treat genotype 3 patients with glecaprevir plus pibrentasvir (one pill/once a day) for (a) 8 weeks, (b)12 weeks, and compare it to the (c) 12 weeks of treatment of sofosbuvir plus daclatasvir. The study was a non-inferiority treatment study – that is the challenge was to find out if the new drug combination was as effective as sofosbuvir/daclatasvir. Note: Genotype 3 is one of the most common genotypes worldwide and has been one of the most difficult to treat with direct-acting antiviral medications (DAAs).
The majority of patients in the trial were males (52%); White (88%); with mild liver disease—no cirrhosis (FO-F1—83%) and relatively younger (~47 yo).
Conclusions: The cure rates were as follows:
Glecaprevir plus pibrentasvir:
a) 8 week treatment arm: 95% (149 of 157 patients)
b) 12 week treatment arm: 95% (222 of 233 patients)
Sofosbuvir plus daclatasvir:
c) 12 week treatment arm: 97% (111 of 115 patients)
The study met the non-inferiority goal (and more) of the study.
There were two discontinuations in the 12 week arms. The most side effects were headache, fatigue and nausea.
Editorial Comments: In clinical trials AbbVie’s new drug combination continues to shine. This study is great news for people with hepatitis C genotype 3 who have had limited treatment options especially because of the high cost of the combination of sofosbuvir and daclatasvir.
This data shows promise to reduce the treatment period for people with HCV genotype 3 who have little or no liver disease damage to a 8-week course of therapy.
This combination is expected to be approved by the Food and Drug Administration (FDA) this year.
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