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FDA Approval for Sofosbuvir by Genotype

for Health Care Providers

FDA Approval for Sofosbuvir

The FDA label for sofosbuvir is summarized in the following table. This table is not a set of practice guidelines or treatment recommendations, but rather, a summary of the recommendations by the FDA when using sofosbuvir. Practice recommendations may vary from this label and may include information other than sofosbuvir. Included in this table are the clinical trials that supported the FDA recommendation.

Table 1. FDA Approval for Sofosbuvir in GENOTYPE 1
Treatment historyCirrhosis statusInterferon eligibilityFDA Approved CourseSVR % (Clinical trial)Comments
Treatment naiveNon-cirrhoticEligibleSofosbuvir + PEG-INF + RBV 12 weeks92%(NEUTRINO)92% GT1a
82% GT1b
Treatment experiencedNon-cirrhoticEligible Sofosbuvir + PEG-INF + RBV12 weeksNo data. Estimated to be 78%
Treatment naiveCirrhoticEligibleSofosbuvir + PEG-INF + RBV12 weeks80% (NEUTRINO)
Treatment experiencedCirrhoticEligibleSofosbuvir + PEG-INF + RBV12 weeksNo data. Estimated to be 71%
Treatment naiveEitherIneligibleSofosbuvir + RBV 24 weeks76% (PHOTON-1)
68% (SPARE)
84%(ELECTRON)

PHOTON-1:HIV positive, 96% non-cirrhotic, 12 wk duration SPARE: mixed eligibility for IFN, multiple negative predictors

ELECTRON: 1 arm of trial, treatment naive, non-cirrhotic, 12 wk duration

Treatment experiencedEitherIneligibleSofosbuvir + RBV24 weeks10% (ELECTRON)ELECTRON: 1 arm of trial, treatment experienced, non-cirrhotic, 12 wk duration
Table 2. FDA Approval for Sofosbuvir in GENOTYPE 2
Treatment historyCirrhosis statusInterferon eligibilityFDA Approved CourseSVR % (Clinical trial)Comments
Treatment naiveNon-cirrhoticNASofosbuvir + ribavirin12 weeks97% (FISSION)
92% (POSITRON)
97% (VALENCE)
Treatment naiveCirrhoticNASofosbuvir + ribavirin12 weeks83% (FISSION--12 wk)
94% (POSITRON--12 wk)
100% (VALENCE)
VALENCE n=2 for cirrhotics
Treatment experiencedNon-cirrhoticIneligible
NA
Sofosbuvir + ribavirin12 weeks90% (FUSION--12 wk)
92% (FUSION--16 wk)
91% (VALENCE)
Treatment experiencedCirrhoticIneligible
NA
Sofosbuvir + ribavirin12 weeks60% (FUSION--12 wk)
78% (FUSION--16 wk)
88% (VALENCE)
VALENCE n=8 for cirrhotics
Table 3. FDA Approval for Sofosbuvir in GENOTYPE 3
Treatment historyCirrhosis statusInterferon eligibilityFDA Approved CourseSVR % (Clinical trial)Comments
Treatment naiveNon-cirrhotic Sofosbuvir + ribavirin24 weeks61% (FISSION - 12 wk)
93% (VALENCE - 24 wk)
Treatment naiveCirrhotic Sofosbuvir + ribavirin24 weeks34% (FISSION -12 wk)
92% (VALENCE - 24 wk)
Treatment naiveNon-cirrhoticIneligibleSofosbuvir + ribavirin24 weeks68% (POSITRON - 12 wk)
Treatment naiveCirrhoticIneligibleSofosbuvir + ribavirin24 weeks21% (POSITRON - 12 wk)
Treatment experiencedNon-cirrhoticEligibleSofosbuvir + ribavirin24 weeks37% (FUSION - 12 wk)
63% (FUSION - 16 wk)
85% (VALENCE - 24 wk)
Treatment experiencedCirrhoticEligibleSofosbuvir + ribavirin24 weeks19% (FUSION - 12 wk) 61%
(FUSION -16 wk) 60%
(VALENCE - 24 wk)
Table 4. FDA Approval for Sofosbuvir in HIV/HCV Coinfected
Genotype
Treatment history
Cirrhosis statusInterferon eligibilityFDA Approved CourseSVR % (Clinical trial)Comments
Genotype 1:
Naive only.
EitherEitherSofosbuvir + ribavirin12 weeks76% (PHOTON-1)PHOTON-1: 4% cirrhotic, all treatment naive, 24 wk course
Genotype 2:
Naive or experienced
EitherEitherSofosbuvir + ribavirin12 weeks88% (PHOTON-1)PHOTON-1: 4% cirrhotic, treatment naive, 12 wk course
Genotype 3:
Naive or experienced
EitherEitherSofosbuvir + ribavirin24 weeks92% (PHOTON-1)PHOTON-1: 4% cirrhotic, treatment naive, 24 wk course

References

NEUTRINO AND FISSION

  • Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368:1878-1887

POSITRON AND FUSION

  • Jacobson IM, Gordon SC, Kowdley KV, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013;368:1867-77.

VALENCE

  • Zeuzem S, Dusheiko GM, Salupere R. Sofosbuvir + ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE trial. Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; November 1-5, 2013; Washington, DC. Abstract 1085.

SPARE

  • Osinusi A, Meissner EG, Lee YJ, et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA. 2013;310:804-811.

PHOTON-1

  • Sulkowski MS, Rodriguez-Torres M, Lalezari JP, et al. All-oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotype 1, 2, and 3 infection in patients co-infected with HIV (PHOTON-1). Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; November 1-5, 2013; Washington, DC. Abstract 212.

ELECTRON

  • Gane EJ, Stedman CA, Hyland RH, et al. All-oral sofosbuvir-based 12-week regimens for the treatment of chronic HCV infection: the ELECTRON study. Program and abstracts of the 48th Annual Meeting of the European Association for the Study of the Liver; April 24-28, 2013; Amsterdam, the Netherlands. Abstract 14.