FDA Updates Hepatitis C Drug Label to Include HIV Recommendations


The US Food and Drug Administration (FDA) announced changes to the Harvoni (ledipasvir/sofosbuvir) label – a hepatitis C drug that was first approved in October 2014.

The US Food and Drug Administration (FDA) announced changes to the Harvoni (ledipasvir/sofosbuvir) label — a hepatitis C drug that was first approved in October 2014.

Harvoni is a treatment option for patients with chronic hepatitis C genotype 1, 4, 5, or 6. The FDA released a report outlining the major changes on November 12, 2015. The key label updates are:

  • Expand the indication to the treatment of chronic hepatitis C virus (HCV) genotype 4, 5, and 6 infections
  • Include dosage recommendations for HCV/HIV-1 co-infection
  • State Harvoni + ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin
  • Updated with drug-drug interaction information

The new recommendations also looked at treatment duration based on genotype:

  • Genotype 1 — treatment-naïve with or without cirrhosis:

- 12 weeks (can be considered for eight weeks if HCV RNA is less than six million IU/mL

  • Genotype 1 — treatment-experienced without cirrhosis:

- 12 weeks

  • Genotype 1 — treatment-experienced with cirrhosis:

- 24 weeks (can be used in combination with ribavirin for 12 weeks for eligible patients — refer to ribavirin guidelines for dosage)

  • Genotype 4, 5, or 6 — treatment-naïve and treatment-experienced, with or without cirrhosis

- 12 weeks

Note that ‘treatment-experienced’ patients are considered those who have failed a peginterferon alfa + ribavirin based regimen (with or without an HCV protease inhibitor).

The majority of adverse effects, regardless of duration, were lack of energy, headache, and fatigue. However, these reactions were at least 5% more frequent in treatment-experienced patients with cirrhosis. Also, they were 5% more frequent in those on 24 weeks of Harvoni or 12 weeks of Harvoni + ribavirin when compared to just the 12 weeks of Harvoni or placebo.

About 25% of people with HIV in the United States are also infected with hepatitis C, according to the Centers for Disease Control and Prevention (CDC). The Harvoni label updates included antiretroviral interactions. Due to the fact that safety has not been established for treatments with tenofovir DF and a HIV protest inhibitor/ritonavir or cobicistat, alternative hepatitis C or antiretroviral therapy should be considered. However, tenofovir DF regimens without a HIV protease inhibitor/ritonavir or cobicistat may be sufficient with the proper monitoring of adverse effects.

Complete updates on the Harvoni label will be posted on Drugs@FDA.

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