Skip to main content

Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options.

Publication ,  Journal Article
Jacobson, IM; Gordon, SC; Kowdley, KV; Yoshida, EM; Rodriguez-Torres, M; Sulkowski, MS; Shiffman, ML; Lawitz, E; Everson, G; Bennett, M; An, D ...
Published in: N Engl J Med
May 16, 2013

BACKGROUND: Patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3 for whom treatment with peginterferon is not an option, or who have not had a response to prior interferon treatment, currently have no approved treatment options. In phase 2 trials, regimens including the oral nucleotide polymerase inhibitor sofosbuvir have shown efficacy in patients with HCV genotype 2 or 3 infection. METHODS: We conducted two randomized, phase 3 studies involving patients with chronic HCV genotype 2 or 3 infection. In one trial, patients for whom treatment with peginterferon was not an option received oral sofosbuvir and ribavirin (207 patients) or matching placebo (71) for 12 weeks. In a second trial, patients who had not had a response to prior interferon therapy received sofosbuvir and ribavirin for 12 weeks (103 patients) or 16 weeks (98). The primary end point was a sustained virologic response at 12 weeks after therapy. RESULTS: Among patients for whom treatment with peginterferon was not an option, the rate of a sustained virologic response was 78% (95% confidence interval [CI], 72 to 83) with sofosbuvir and ribavirin, as compared with 0% with placebo (P<0.001). Among previously treated patients, the rate of response was 50% with 12 weeks of treatment, as compared with 73% with 16 weeks of treatment (difference, -23 percentage points; 95% CI, -35 to -11; P<0.001). In both studies, response rates were lower among patients with genotype 3 infection than among those with genotype 2 infection and, among patients with genotype 3 infection, lower among those with cirrhosis than among those without cirrhosis. The most common adverse events were headache, fatigue, nausea, and insomnia; the overall rate of discontinuation of sofosbuvir was low (1 to 2%). CONCLUSIONS: In patients with HCV genotype 2 or 3 infection for whom treatment with peginterferon and ribavirin was not an option, 12 or 16 weeks of treatment with sofosbuvir and ribavirin was effective. Efficacy was increased among patients with HCV genotype 2 infection and those without cirrhosis. In previously treated patients with genotype 3 infection, 16 weeks of therapy was significantly more effective than 12 weeks. (Funded by Gilead Sciences; POSITRON and FUSION ClinicalTrials.gov numbers, NCT01542788 and NCT01604850, respectively.).

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 16, 2013

Volume

368

Issue

20

Start / End Page

1867 / 1877

Location

United States

Related Subject Headings

  • Young Adult
  • Uridine Monophosphate
  • Treatment Outcome
  • Sofosbuvir
  • Ribavirin
  • RNA, Viral
  • Middle Aged
  • Male
  • Logistic Models
  • Liver Cirrhosis
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Jacobson, I. M., Gordon, S. C., Kowdley, K. V., Yoshida, E. M., Rodriguez-Torres, M., Sulkowski, M. S., … FUSION Study, . (2013). Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med, 368(20), 1867–1877. https://doi.org/10.1056/NEJMoa1214854
Jacobson, Ira M., Stuart C. Gordon, Kris V. Kowdley, Eric M. Yoshida, Maribel Rodriguez-Torres, Mark S. Sulkowski, Mitchell L. Shiffman, et al. “Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options.N Engl J Med 368, no. 20 (May 16, 2013): 1867–77. https://doi.org/10.1056/NEJMoa1214854.
Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013 May 16;368(20):1867–77.
Jacobson, Ira M., et al. “Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options.N Engl J Med, vol. 368, no. 20, May 2013, pp. 1867–77. Pubmed, doi:10.1056/NEJMoa1214854.
Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, Shiffman ML, Lawitz E, Everson G, Bennett M, Schiff E, Al-Assi MT, Subramanian GM, An D, Lin M, McNally J, Brainard D, Symonds WT, McHutchison JG, Patel K, Feld J, Pianko S, Nelson DR, POSITRON Study, FUSION Study. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013 May 16;368(20):1867–1877.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 16, 2013

Volume

368

Issue

20

Start / End Page

1867 / 1877

Location

United States

Related Subject Headings

  • Young Adult
  • Uridine Monophosphate
  • Treatment Outcome
  • Sofosbuvir
  • Ribavirin
  • RNA, Viral
  • Middle Aged
  • Male
  • Logistic Models
  • Liver Cirrhosis