3-Drug Regimen Reduces HCV Treatment Duration

Patients who adhered to 2 different 3-drug regimens for a 6-week duration had high cure rates for hepatitis C virus (HCV), according to a new study.

Further, the addition of a third direct-acting viral drug could decrease the treatment duration necessary to achieve viral response sustainability in patients living with chronic HCV genotype 1 infection.

In order to assess the effects of the addition of a third direct-acting antiviral drug to the combination of sofosbuvir and ledipasvir, researchers assigned 60 patients with the HCV genotype 1 infection to one of 3 groups: sofosbuvir and ledipasvir (12 weeks), ledipasvir, sofosbuvir, and GS-9669 (6 weeks), or 6 weeks of sofosbuvir, ledipasvir, and GS-9451.
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Researchers assessed serum HCV RNA concentrations to determine how many participants sustained viral response after SVR12 completion at 12 weeks. According the investigators, the concentrations used to assess viral response were required to be lower than 43 IU/mL.

The study showed that all 20 participants of the group assigned sofosbuvir and ledipasvir for 12 weeks achieved sustained virologic response (SVR).

Further, while 1 participant relapsed after completing treatment, 19 participants in the second group (ledipasvir, sofosbuvir, and GS-9669 ) showed no signs of HCV after being tested at 12 weeks.

Researchers noted that 1 participant was lost to follow-up after sustaining viral response at week 4 of treatment in the third group (sofosbuvir, ledipasvir, and GS-9451), but the other 19 participants achieved SVR by the end of 6 weeks.

Investigators noticed that while no patients discontinued treatment and most adverse events were mild, 2 serious adverse events occurred in the form of vertigo and pain (after post-treatment for a liver biopsy), which were unrelated to the drugs used in the study.

“Addition of a third potent direct-acting antiviral drug can reduce the duration of treatment required to achieve sustained viral response in patients with chronic HCV genotype 1 infection without cirrhosis,” and “shorter courses could improve affordability and adherence,” they concluded.

The complete study is published in the January issue of the Lancet.

-Michelle Canales

Reference:

Kohli A, Osinusi A, Sims Z, et al. Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study. Lancet. 2015 January [epub ahead of print] doi: http://dx.doi.org/10.1016/S0140-6736(14)61228-9.