HCV Drug Harvoni Updated to Include Recommendations for HIV

Antiretroviral drug interactions now included due to high prevalence of HIV coinfection among patients with hepatitis C virus.

Antiretroviral drug interactions now included due to high prevalence of HIV coinfection among patients with hepatitis C virus.

The FDA recently announced an update to the label for the breakthrough hepatitis C drug ledipasvir/sofosbuvir (Harvoni).

Harvoni treats patients with chronic hepatitis C virus (HCV) genotypes 1, 4, 5, or 6.

The label updates include:

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

The label updates also include new information on specific genotype treatment duration.

Patients with genotype 1 who are treatment-naïve with or without cirrhosis:

  • 12-week treatment regimen (8 weeks is an option if HCV RNA is less than six million IU/mL)

Patients with genotype 1 who are treatment-experienced without cirrhosis:

  • 12-week treatment regimen

Patients with genotype 1 who are treatment-experienced with cirrhosis:

  • 24-week treatment regimen (can be used in combination with ribavirin for 12 weeks among eligible patients)

Patients with genotypes 4, 5, or 6 who are treatment-naïve and treatment-experienced, with or without cirrhosis:

  • 12-week treatment regimen

The FDA deemed treatment-experienced patients as those who failed a peginterferon alfa + ribavirin based regimen, with or without an HCV protease inhibitor.

Most of the side effects from treatment, regardless of the regimen duration, were lack of energy, headache, and fatigue, which occurred 5% more frequently in treatment-experienced patients with cirrhosis.

These adverse events were also 5% more frequent in patients on a 24-week Harvoni regimen or a 12-week Harvoni with ribavirin regimen compared with the 12-week Harvoni or placebo regimen.

Due to the fact that 25% of people infected with HIV in the United States are coinfected with HCV, the updated Harvoni label includes antiretroviral drug interactions. With the safety of tenofovir DF and an HIV protease inhibitor/ritonavir or cobicistat still undetermined, alternative HCV or antiretroviral therapies should be considered.

Although the FDA noted that tenofovir DF regimens without an HIV protease inhibitor/ritonavir or cobicistat may be sufficient with proper monitoring of adverse events.