Active Ingredient	Daclatasvir
Manufacturer	Hetero
Origin	India
Reference	N/A

What is Daclahep (Daclatasvir) used for?

Daclahep (Daclatasvir Dihydrochloride) is a direct-acting antiviral agent (DAA) against the hepatitis C virus and is used to treat patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.

Daclatasvir is an inhibitor of NS5A, a nonstructural protein encoded by HCV. Daclatasvir binds to the N-terminus of NS5A and inhibits both viral RNA replication and virion assembly.

How should I use Daclahep (Daclatasvir)?

The recommended dosage in most people is one 60mg tablet taken each day for a period of 12 weeks.

Daclahep should always be taken with Sofosbuvir or with Sofosbuvir and Ribavirin according to the following guidelines:

• Patients with Genotype 1 infection:
  • no cirrhosis - daclatasvir + sofosbuvir
  • compensated cirrhosis - daclatasvir + sofosbuvir
  • decompensated cirrhosis - daclatasvir + sofosbuvir + ribavirin
  • post-transplant - daclatasvir + sofosbuvir + ribavirin
• Patients with Genotype 1 infection:
  • no cirrhosis - daclatasvir + sofosbuvir
  • compensated cirrhosis - daclatasvir + sofosbuvir + ribavirin
  • decompensated cirrhosis - daclatasvir + sofosbuvir + ribavirin
  • post-transplant - daclatasvir + sofosbuvir + ribavirin

What are the side effects of Daclahep (Daclatasvir)?

The most common side effects encountered when taking Daclatasvir and Sofosbuvir are headache, fatigue, nausea and diarrhea.

When Ribavirin is also taken, patients have also reported anemia, rash, insomnia, dizziness and somnolence as side effects.

Please Note

Patients who are taking Amiodarone with Daclahep and Sofosbuvir may experience serious symptomatic bradycardia, especially if they are taking beta-blockers or have heart problems or liver disease.

Daclatasvir is should not be taken alongside when taking strong inducers of CYP3A such as phenytoin, carbamazepine, rifampin, and St. John's wort.

Some medicines interact with Daclatasvir. You may need to be monitored carefull if you taker any of the following with daclatasvir:

• Protease inhibitors (atazanavir with ritonavir, indinavir, nelfinavir, saquinavir)
• Other antiretrovirals (eg. atazanavir/cobicistat, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate)
• Non-nucleoside reverse transcriptase inhibitors (efavirenzb, etravirine, nevirapine)
• Strong CYP3A inhibitors (eg. clarithromycin, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, voriconazole)
• Moderate CYP3A inducers (eg. bosentan, dexamethasone, modafinil, nafcillin, rifapentine)
• Anticoagulants (dabigatran etexilate mesylate)
• Cardiovascular agents (Amiodarone, Digoxin)
• HMG-CoA reductase inhibitors (Atorvastatin, Fluvastatin, Pitavastatin, Pravastatin, Rosuvastatin, Simvastatin)
• Narcotic Analgesics (buprenorphine, buprenorphine/naloxone)

Daclatasvir may increase the risk of birth defects and miscarriage. Before taking daclatasvir, tell your doctor if:

• you are pregnant, trying to become pregnant or breast-feeding
• your partner is pregnant or trying to become pregnant

Safety of Daclatasvir in patients under 18 years has not been established.