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Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.

Publication ,  Journal Article
Kowdley, KV; Gordon, SC; Reddy, KR; Rossaro, L; Bernstein, DE; Lawitz, E; Shiffman, ML; Schiff, E; Ghalib, R; Ryan, M; Rustgi, V; Chojkier, M ...
Published in: N Engl J Med
May 15, 2014

BACKGROUND: High rates of sustained virologic response were observed among patients with hepatitis C virus (HCV) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir. This study examined 8 weeks of treatment with this regimen. METHODS: In this phase 3, open-label study, we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir-sofosbuvir) for 8 weeks, ledipasvir-sofosbuvir plus ribavirin for 8 weeks, or ledipasvir-sofosbuvir for 12 weeks. The primary end point was sustained virologic response at 12 weeks after the end of therapy. RESULTS: The rate of sustained virologic response was 94% (95% confidence interval [CI], 90 to 97) with 8 weeks of ledipasvir-sofosbuvir, 93% (95% CI, 89 to 96) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin, and 95% (95% CI, 92 to 98) with 12 weeks of ledipasvir-sofosbuvir. As compared with the rate of sustained virologic response in the group that received 8 weeks of ledipasvir-sofosbuvir, the rate in the 12-week group was 1 percentage point higher (97.5% CI, -4 to 6) and the rate in the group that received 8 weeks of ledipasvir-sofosbuvir with ribavirin was 1 percentage point lower (95% CI, -6 to 4); these results indicated noninferiority of the 8-week ledipasvir-sofosbuvir regimen, on the basis of a noninferiority margin of 12 percentage points. Adverse events were more common in the group that received ribavirin than in the other two groups. No patient who received 8 weeks of only ledipasvir-sofosbuvir discontinued treatment owing to adverse events. CONCLUSIONS: Ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis. No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks. (Funded by Gilead Sciences; ION-3 ClinicalTrials.gov number, NCT01851330.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 15, 2014

Volume

370

Issue

20

Start / End Page

1879 / 1888

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Load
  • Uridine Monophosphate
  • Sofosbuvir
  • Ribavirin
  • RNA, Viral
  • Middle Aged
  • Male
  • Humans
  • Hepatitis C, Chronic
 

Citation

APA
Chicago
ICMJE
MLA
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Kowdley, K. V., Gordon, S. C., Reddy, K. R., Rossaro, L., Bernstein, D. E., Lawitz, E., … ION-3 Investigators, . (2014). Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med, 370(20), 1879–1888. https://doi.org/10.1056/NEJMoa1402355
Kowdley, Kris V., Stuart C. Gordon, K Rajender Reddy, Lorenzo Rossaro, David E. Bernstein, Eric Lawitz, Mitchell L. Shiffman, et al. “Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.N Engl J Med 370, no. 20 (May 15, 2014): 1879–88. https://doi.org/10.1056/NEJMoa1402355.
Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014 May 15;370(20):1879–88.
Kowdley, Kris V., et al. “Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.N Engl J Med, vol. 370, no. 20, May 2014, pp. 1879–88. Pubmed, doi:10.1056/NEJMoa1402355.
Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, Shiffman ML, Schiff E, Ghalib R, Ryan M, Rustgi V, Chojkier M, Herring R, Di Bisceglie AM, Pockros PJ, Subramanian GM, An D, Svarovskaia E, Hyland RH, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Pound D, Fried MW, ION-3 Investigators. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014 May 15;370(20):1879–1888.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 15, 2014

Volume

370

Issue

20

Start / End Page

1879 / 1888

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Load
  • Uridine Monophosphate
  • Sofosbuvir
  • Ribavirin
  • RNA, Viral
  • Middle Aged
  • Male
  • Humans
  • Hepatitis C, Chronic