Top 10 Practice Changers in Gastroenterology: 2014

David A. Johnson, MD


December 09, 2014

In This Article

Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection

Afdhal N, Zeuzem S, Kwo P, et al; ION-1 Investigators
N Engl J Med. 2014;370:1889-1898

Is All-Oral Hepatitis C Treatment Effective?

In phase 2 studies, treatment with the all-oral combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir resulted in high rates of sustained virologic response (SVR) among previously untreated patients with hepatitis C virus (HCV) genotype 1 infection. In this phase 3 study, patients were randomly assigned in a 1:1:1:1 ratio to receive ledipasvir/sofosbuvir in a fixed-dose combination tablet once daily for 12 weeks, ledipasvir/sofosbuvir plus ribavirin for 12 weeks, ledipasvir/sofosbuvir for 24 weeks, or ledipasvir/sofosbuvir plus ribavirin for 24 weeks. The primary endpoint was SVR at 12 weeks after the end of therapy.

The SVR rates for these four groups are shown in the Table.

Table. SVR Rates for Four Hepatitis C Regimens

Treatment Group SVR 95% CI
Ledipasvir/sofosbuvir fixed dose: 12 weeks 99% 96%-100%
Ledipasvir/sofosbuvir plus ribavirin: 12 weeks 97% 94%-99%
Ledipasvir/sofosbuvir fixed dose: 24 weeks 98% 95%-99%
Ledipasvir/sofosbuvir plus ribavirin: 24 weeks 99% 97%-100%

CI = confidence interval; SVR = sustained virologic response

One-pill treatment for hepatitis C, without the side effects of interferon or ribavirin, clearly shows that cure of hepatitis C is now nearly a given!



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