Recent new approvals for Hep C treatment bring additional Hep C treatment options for the Hepatitis C virus.  Daklinza (daclatasvir) by Bristol Myers-Squibb was approved July 2015 for genotype 3, a once daily pill for use in combination with sofosbuvir, which is used without Interferon. Genotype 3 is the second most common genotype in the United States, with genotype 1 being the most prevalent.

The expanded treatment options for Daklinza include the following:

  1. HCV genotype 1 and 3 patients co-infected with HIV-1
  2. HCV genotype 1 and 3 post-transplant patients
  3. HCV genotype 1 patients with compensated (Child-Pugh A) cirrhosis and decompensated (Child-Pugh B or C) patients
  4. HCV genotype 3 patients with decompensated (Child-Pugh B or C) cirrhosis

Additionally, drug to drug interactions data regarding Daklinza coadministered with buprenorphine/naloxone, darunavir/ritonavir, or lopinavir/ritonavir were included in the label.

NS5A resistance testing is recommended for Hep C patients with genotype 1a-with cirrhosis. Screening for the presence of NS5A polymorphisms at amino acid positions M28, Q30, L31, and Y93 is recommended.

Daklinza is a 60 mg oral medication taken once daily, with or without food. Daklinza can be taken with or without Ribavirin depending on liver condition.

Treatment and Duration:

Table 1:               Recommended Treatment Regimen and Duration for DAKLINZA in Patients with Genotype 1 or 3 HCV
  Patient Population Treatment and Duration
Genotype 1 Without cirrhosis DAKLINZA + sofosbuvir for 12 weeks
Compensated (Child-Pugh A) cirrhosis
Decompensated (Child-Pugh B or C) cirrhosis DAKLINZA + sofosbuvir + ribavirin for 12 weeks
Post-transplant
Genotype 3 Without cirrhosis DAKLINZA + sofosbuvir for 12 weeks
Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis DAKLINZA + sofosbuvir + ribavirin for 12 weeks
Post-transplant

Dosage Modification Due to Drug Interactions

Refer to the drug interactions and contraindications sections for other drugs before coadministration with DAKLINZA.

Table 2: Recommended DAKLINZA Dosage Modification with CYP3A Inhibitors and Inducers
Concomitant Drugs DAKLINZA Dosage
Strong CYP3A inhibitors and certain HIV antiviral agents (see Drug Interactions (7.3) for a complete list) 30 mg once daily (one 30 mg tablet)
Moderate CYP3A inducers and nevirapine (see Drug Interactions (7.3) for a complete list) 90 mg once daily (three 30 mg tablets, or one 60 mg and one 30 mg tablet)
Strong CYP3A inducers (see Contraindications (4) for a complete list) Contraindicated

News of FDA approval to expand treatment options for Daklinza (daclatasvir)by Bristol Myers-Squibb, comes on the heels of recent approval for new Hep C treatment Zepatier, by Merck, for genotype 1 and 4.  Another win with expanded treatment options against the Hepatitis C virus.

Daklinza’s expanded treatment brings new options to a wide variety of Hep C patients with various degrees of liver damage whom otherwise limited treatment has been available.

The race to bring the cure continues with more Hep C treatment under review by the FDA and predicted to be approved this summer (2016).

Where are you in your journey with Hep C?

This entry was originally published on Life Beyond Hepatitis C, February 11, 2016. It is reprinted with permission.