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N Engl J Med. 2015 Dec 31;373(27):2618-28. doi: 10.1056/NEJMoa1512614. Epub 2015 Nov 16.

Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.

Author information

1
From the Beth Israel Deaconess Medical Center, Boston (M.P.C.); Baylor University Medical Center, Dallas (J.G.O.), and Texas Liver Institute, University of Texas Health Science Center, San Antonio (E.L.) - both in Texas; Ochsner Medical Center, New Orleans (N.B.); Duke University, Durham (A.J.M.), and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.F.) - both in North Carolina; Washington University School of Medicine, St. Louis (K.M.K.); Thomas Jefferson University (J.M.F.) and University of Pennsylvania School of Medicine (K.R.R.) - both in Philadelphia; Northwestern University, Chicago (S.L.F.); Mount Sinai Hospital (T.S.), New York University School of Medicine (L.T.), and Weill Cornell Medical College (R.S.B.) - all in New York; University of Michigan, Ann Arbor (R.F.); University of Miami, Miami (E.S.); Gilead Sciences, Foster City, CA (B.D., D.A., J.M., A.O., D.M.B., J.G.M.); and Intermountain Medical Center, Salt Lake City (M.C.).

Abstract

BACKGROUND:

As the population that is infected with the hepatitis C virus (HCV) ages, the number of patients with decompensated cirrhosis is expected to increase.

METHODS:

We conducted a phase 3, open-label study involving both previously treated and previously untreated patients infected with HCV genotypes 1 through 6 who had decompensated cirrhosis (classified as Child-Pugh-Turcotte class B). Patients were randomly assigned in a 1:1:1 ratio to receive the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir once daily for 12 weeks, sofosbuvir-velpatasvir plus ribavirin for 12 weeks, or sofosbuvir-velpatasvir for 24 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy.

RESULTS:

Of the 267 patients who received treatment, 78% had HCV genotype 1, 4% genotype 2, 15% genotype 3, 3% genotype 4, and less than 1% genotype 6; no patients had genotype 5. Overall rates of sustained virologic response were 83% (95% confidence interval [CI], 74 to 90) among patients who received 12 weeks of sofosbuvir-velpatasvir, 94% (95% CI, 87 to 98) among those who received 12 weeks of sofosbuvir-velpatasvir plus ribavirin, and 86% (95% CI, 77 to 92) among those who received 24 weeks of sofosbuvir-velpatasvir. Post hoc analysis did not detect any significant differences in rates of sustained virologic response among the three study groups. Serious adverse events occurred in 19% of patients who received 12 weeks of sofosbuvir-velpatasvir, 16% of those who received 12 weeks of sofosbuvir-velpatasvir plus ribavirin, and 18% of those who received 24 weeks of sofosbuvir-velpatasvir. The most common adverse events were fatigue (29%), nausea (23%), and headache (22%) in all patients and anemia (31%) in the patients receiving ribavirin.

CONCLUSIONS:

Treatment with sofosbuvir-velpatasvir with or without ribavirin for 12 weeks and with sofosbuvir-velpatasvir for 24 weeks resulted in high rates of sustained virologic response in patients with HCV infection and decompensated cirrhosis. (Funded by Gilead Sciences; ASTRAL-4 ClinicalTrials.gov number, NCT02201901.).

PMID:
26569658
DOI:
10.1056/NEJMoa1512614
[Indexed for MEDLINE]
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