Daclatasvir (Oral)

Overview

Daclatasvir is an antiviral medication, classified as a HCV NS5A replication complex inhibitor, which was approved for use in the United States in 2015 and used to treat chronic hepatitis C infections and reduce long-term risk of liver damage. It is the only drug classified in exactly this way that is currently available in the United States. This medication is taken in combination with other medications. The combination of medications prescribed varies on the patient's medical history, including any prior history of liver damage.

Metabolized by the liver, Daclatasvir prevents HCV viral RNA replication by inhibiting HCV protein. This medication interferes with certain proteins and processes necessary for hepatitis C to multiply and form new viruses. Daclatasvir is recommended for use with Sofosbuvir and may also be administered with Ribavirin. The treatment course is generally around 12 weeks.

Daclatasvir is generally prescribed to patients with hepatitis C infections lasting six months or longer and most commonly prescribed along with Sofosbuvir. This medication may also be prescribed to patients diagnosed with both hepatitis C and human immunodeficiency virus (HIV). Daclatasvir can be taken by patients with liver disease, including cirrhosis. However, it is more effective for those without liver damage.

Conditions Treated

  • Chronic hepatitis C infection

Type Of Medicine

  • Antiviral

Side Effects

Side effects are rare when Daclatasvir is taken alone, however, the medication is generally prescribed along with complimentary medications. The most common side effects of a regimen including Declatasvir include fatigue, headaches, and nausea. Diarrhea is a less common side effect, but it may occur.

When Daclatasvir is taken along with Interferon and Ribavirin, additional side effects may be experienced. Ribavirin, which is known to cause birth defects, is commonly prescribed along with Daclatasvir, and for this reason, patients taking the medication should not be pregnant or planning to become pregnant. Side effects of Daclatasvir combined with Interferon and Ribavirin include:

  • Fever
  • Muscle and joint aches
  • Depression
  • Itching
  • Anemia
  • Neutropenia

Immediate medical attention should be sought if any of the following side effects occur.

  • Fainting
  • Dizziness
  • Lightheadedness
  • Chest pain
  • Shortness of breath
  • Slow or irregular heartbeat
  • Excessive fatigue

Dosage

As with any medication, it is important to take Daclatasvir only as prescribed by a physician. This medication should not be shared or taken by any person to whom it is not prescribed. If directed to take this medication as a combination treatment, all medications must be taken as directed in order to work effectively. Patients should take this medication exactly as directed and not take it more often or for a longer time than ordered. In order to completely clear up a hepatitis C infection, the medication must be taken on a regular schedule and until a physician determines that it may be stopped, even if the patient is feeling better.

Daclatasvir is taken orally. This medication may be taken with or without food. The dosage prescribed will vary on the medical circumstances of the individual patient. The amount of Daclatasvir taken will depend on its strength. The number of doses taken each day, the time between doses and the treatment time will vary based on the patient's medical history.

Daclatasvir is taken orally, in tablet form. It is often prescribed in combination with Sofosbuvir with 60 milligrams taken once per day for 12 weeks. This medication is available in both 30 and 60mg tablets. The patient may be prescribed a 30 mg dose or a 90 mg dose, based on their medical history and any previous liver damage. Dosage for children must be determined by a physician.

Missed doses should be taken as soon as possible, unless it is close to the time indicated for the next dose. Double doses of Daclatasvir should not be taken.

Daclatasvir should only be taken as prescribed. In the case of an accidental overdose, 911 should be called.

Major Drug Interactions:

Taking another drug, herb or nutritional supplement together with Daclatasvir can cause adverse side effects. Taking Daclatasvir with any of the medications listed below is not recommended.

  • Carbamazepine
  • Enzalutamide
  • Fosphenytoin
  • Mitotane
  • Phenytoin
  • Rifampin
  • St John's Wort

In certain cases, taking another medication along with Daclatasvir may be necessary. A physician may ask the patient to stop taking the following medications, or may change the dose. The following medications should only be taken with Daclatasvir if recommended by the prescribing physician:

  • Amiodarone
  • Boceprevir
  • Bosentan
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Dexamethasone
  • Digoxin
  • Efavirenz
  • Etravirine
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Modafinil
  • Nafcillin
  • Nefazodone
  • Nelfinavir
  • Nevirapine
  • Oxcarbazepine
  • Phenobarbital
  • Posaconazole
  • Prednisone
  • Primidone
  • Rifabutin
  • Ritonavir
  • Saquinavir
  • Simeprevir
  • Telaprevir
  • Telithromycin
  • Voriconazole

The prescribing physician may also provide specific instructions on the use or consumption of certain foods, alcohol or tobacco for patients taking Daclatasvir. Alcohol or tobacco use may be limited during treatment, based on the recommendation of the prescribing physician. It is recommended that patients avoid consuming grapefruit juice while taking this medication.

Warnings

The prescribing physician should be notified before this medication is stopped. Regular visits to the prescribing physician are recommended when using Daclatasvir, to ensure that it is working properly. Additional prescription or nonprescription drugs, herbs or supplements should not be used while taking Daclatasvir without first consulting a physician.

Using Daclatasvir in combination with Sofosbuvir and Amiodarone could increase the risk of bradycardia.

The prescribing physician should be notified of any medication allergies. Other allergies, including those to foods, animals, dyes or preservatives should also be reported. All packaging should be reviewed thoroughly to ensure that there are no allergies to ingredients.

Side effects have been reported with the use of Daclatasvir along with Interferon and Ribavirin, including muscle and joint aches, depression, anemia, neutropenia, and itching. Because Ribavarin is known to cause birth defects, it should not be used as part of a Daclatasvir regimen by women who are pregnant, are planning to become pregnant or by their male partners. It is unknown whether Daclatasvir is passed on through breast milk. The decision to use Daclatasvir while pregnant or breastfeeding should be made in consultation with a physician.

Daclatasvir has been known to cause hepatitis B virus reactivation. A physician should complete blood tests to check for a hepatitis B virus infection before Daclatasvir is taken. Any patient who has ever had hepatitis B is at risk of having the virus reactivate during or after treatment with Daclatasvir. This can lead to serious liver problems, including liver failure or death. The prescribing physician should monitor the patient if they are at risk of a hepatitis B reactivation.

Prior to taking Daclatasvir, the patient should inform the prescribing physician of any and all medical conditions, including any liver problems outside of the hepatitis C infection, heart problems or a liver transplant.

Severe liver damage can inhibit the effectiveness of Daclatasvir. For this reason, it is recommended that prescribing physicians monitor patients throughout treatment. Lab tests should be given, especially during the first four weeks of therapy with Daclatasvir. Should any signs of further liver damage, jaundice or hepatic decompensation arise, treatment with Daclatasvir should be interrupted. In rare cases, Daclatasvir has been known to cause acute decompensation of HCV related cirrhosis during or following treatment.

The prescribing physician should be informed of any medications taken, including all over the counter medications and dietary supplements. Certain foods and beverages, including grapefruit juice, could affect the way that Daclatasvir works.

In combination with Sofosbuvir and Amiodarone, Daclatasvir has been known to cause bradycardia. A physician should be notified immediately if a patient taking Daclatasvir experiences memory problems, weakness, fainting, chest pain, dizziness, extreme fatigue, confusion or shortness of breath.

The safety of Daclatasvir for children has not been determined. Daclatasvir should not be used by children unless ordered by a physician.

Storage

Daclatasvir should be stored in a closed container kept at room temperature, or approximately 77°F, and away from moisture, heat and direct light. This medication should not be frozen. All tablets should be taken as prescribed and kept out of the reach of children and pets. A healthcare professional should be consulted on the proper disposal of any unused medication.

Summary

Daclatasvir is an antiviral medication, classified as a HCV NS5A replication complex inhibitor, used to treat and shorten the treatment of hepatitis C infections. It is generally used in combination with other medications, most specifically Sofosbuvir. Specifically, Daclatasvir is indicated for use by patients with hepatitis C infections lasting six months or longer. This medication works by interfering with a protein that the hepatitis C virus uses to reproduce.

Metabolized in the liver, Daclatasvir can be taken by patients with all stages of liver disease, but works better for those with less severe liver damage. Taken alone, Daclatasvir has few reported side effects, however, it is most often prescribed along with other medications. Taking Daclatasvir in combination with other drugs may lead to low white blood cell count, fever, muscle and joint pain, depression, itching, and anemia. Lab monitoring during the course of this medication is recommended.

This medication should be taken only as prescribed and the full treatment course should be adhered to. Any medication prescribed along with Daclatasvir should also be taken as prescribed. The dosage of this medication will determine the medical history of the patient to whom it is being prescribed. Treatment time varies by individual but usually lasts around 12 weeks.

Treatment with Daclatasvir for children, pregnant or breastfeeding women and their male partners should be decided upon only through consultation with a physician. This medication should only be taken by those it is prescribed to, kept in the bottle at room temperature and kept out of the reach of children and pets. Daclatasvir is taken orally and is available in tablet form in 30mg and 60mg doses. A 60mg dose is most commonly prescribed. Successful treatment with Daclatasvir can shorten treatment of the hepatitis C infection and reduce the risk of long-term complications, including liver damage.