FDA Approves First Single-Treatment Pill for HCV

By Kristin J. Kelley

Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD

The FDA has approved the first single-treatment pill — a combination of ledipasvir and sofosbuvir — to treat hepatitis C genotype 1. Marketed as Harvoni, the pill is also the first regimen that doesn't have to be given with interferon or ribavirin.

Ledipasvir and sofosbuvir prevent HCV cells from multiplying. Approval for the combination tablet was based on three randomized trials of some 1500 patients; some were treatment-naive and some did not respond to other treatments. Roughly 95% of patients in all three studies obtained sustained virologic response (no HCV in the blood) after 12 weeks of treatment with the combination pill. Fatigue and headache were the most common side effects.

Writing in HIV and ID Observations, Dr. Paul Sax calls Harvoni "the treatment of choice ... for genotype 1 patients" now, due not only to the effectiveness of the regimen, but also to the price and the few serious drug-drug interactions.