Approval of Sovaldi (sofosbuvir) tablets for the treatment of chronic hepatitis C

A nucleotide analog NS5B polymerase inhibitor was approved by the FDA for treatment of chronic hepatitis C (HCV). It is used for genotypes 1-4, in combination with peginterferon and/or ribavirin.  Some of the advantages to previous treatments are: activity against all HCV strains, oral administration, fewer adverse effects than peginterferon, and low probability of develping viral resistance.Notably, patients with genotype 1 or 4 HCV infection had a very high rate of sustained virologic response (90%) at 12 weeks.
 
Some excerpts from the FDA website:
On December 6, 2013, FDA approved SOVALDI (sofosbuvir) tablets for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
SOVALDI is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection
 
DOSAGE AND ADMINISTRATION
The recommended dose of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food.
SOVALDI should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC in adults. The recommended regimen and treatment duration for SOVALDI combination therapy is provided in Table 1.

Table 1           Recommended Regimens and Treatment Duration for SOVALDI Combination Therapy in HCV Mono-infected and HCV/HIV-1 Co-infected Patients

  Treatment Duration
Patients with genotype 1 or 4 CHC  SOVALDI + peginterferon alfa + ribavirin 12 weeks
Patients with genotype 2 CHC  SOVALDI + ribavirin 12 weeks
Patients with genotype 3 CHC  SOVALDI + ribavirin 24 weeks

SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for CHC patients with genotype 1 infection who are ineligible to receive an interferon-based regimen.Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient.

More at: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm377920.htm

Links to reported clinical studies: http://www.nejm.org/doi/full/10.1056/NEJMoa1214853#t=article
http://www.nejm.org/doi/full/10.1056/NEJMoa1306218

 
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