Generic Name: daclatasvir
Drug Class: NS5A Inhibitors
Company: Bristol-Myers Squibb
Approval Status: Approved
Generic Version Available: No
Experimental Code: BMS 790052
Daklinza is approved for use with Sovaldi (sofosbuvir) for the treatment of chronic hepatitis C genotypes 1 and 3. Testing prior to initiation: HCV genotype 1a with cirrhosis, consider testing for the presence of virus with NS5A resistance-associated polymorphisms.
- Daklinza was approved by the U.S. Food and Drug Administration for use by people living with hepatitis C on July 24, 2015.
- In clinical trials, 97 percent of genotype 1 participants who were coninfected with HCV/HIV were cured with 12 weeks of therapy. Approximately 90 percent of treatment-naive genotype 3 participants were cured with 12 weeks of therapy; treatment-experienced participants had 86 percent cure rates with 12 weeks of treatment. Genotype 3 participants without cirrhosis, regardless of treatment history, had 96 percent cure rates; participants with cirrhosis had 63 percent cure rates.
Adult Dose: One tablet taken orally once daily in combination with Sovaldi. May be taken with or without food. The optimal duration of Daklinza plus Sovaldi for people with cirrhosis has not been established.
Pediatric Dose: N/A
Side effects associated with Daklinza are considered mild. The most common are headache, fatigue, nausea, and diarrhea.
- Before taking this medication, tell your medical provider and pharmacist about all the drugs, supplements and herbs you take, whether prescribed, over-the-counter or illicit.
- Patients taking amiodarone should not take Sovaldi, and thus should not take Daklinza; heart-related complications, including one death, have been reported by patients taking Sovaldi.
- Daklinza should not be taken with certain drugs and herbs that are metabolized in the liver and intestines such as phenytoin, rifampin, and St. John’s wort.
- Additionally, Daklinza may interact with some drugs that may still be taken, but their dosages may need to be modified. For example, the dose of Daklinza may need to be increased when taking digoxin, efavirenz and various lipid-lowering medications. Conversely, the dose of Daklinza may need to be reduced when taking ciprofloxacin, erythromycin, fluconazole, ketoconazole, ritonavir and verapamil.
- Additional drug-drug interactions may occur, and these are listed in Daklinza’s Full Prescribing Information. Potential interactions are listed at hep-druginteractions.org.
- Warning: Patients who are coinfected with hepatitis B and C who take this medication may be at risk of hepatitis B virus (HBV) reactivation. Before taking this medication, be sure your doctor has tested you for evidence of current or prior hepatitis B virus infection. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in serious hepatitis flares, liver failure, and death.
- There are no adequate, well-controlled studies in pregnant women who have taken Daklinza. Daklinza should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
- The safety of breast feeding while taking Daklinza has not been established.
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Last Reviewed: March 5, 2019