Daklinza

Introduction

Daklinza is a new, highly effective, and orally available hepatitis C virus (HCV) treatment. It is a nucleotide analog inhibitor of the HCV NS5B polymerase, which is essential for HCV replication. Daklinza was approved by the U.S. Food and Drug Administration (FDA) in December 2017 for the treatment of chronic HCV genotype 1 infection.

Daklinza is a once-daily pill taken with food. The pill is taken for 12 weeks, followed by a 12-week treatment interruption. The pill is well-tolerated and has a favorable safety profile. Daklinza was found to be effective in a Phase 3 study in which it was compared to sofosbuvir (Sovaldi) and ledipasvir/sofosbuvir (Harvoni). The study found that Daklinza was more effective than sofosbuvir and ledipasvir/sofosbuvir in reducing the number of HCV RNA copies in the blood. Daklinza was also found to be more effective than sofosbuvir and ledipasvir/sofosbuvir in reducing the number of HCV-related liver events.

Daklinza is expected to be available in the U.S. in the second half of 2018.

Composition

The active ingredient in Daklinza is daclatasvir. This is a nucleotide analog inhibitor of the NS5A protein. NS5A is a key protein in the replication of the HIV virus.

Usage

Daklinza is used to treat hepatitis C virus (HCV) infections. It is a pill taken by mouth. Daklinza is also used to prevent HCV infections in people who are at risk for them. Daklinza is also used to treat other liver diseases. Daklinza is not used to treat other types of cancer.

Daklinza is not approved for use in people younger than 18 years old. Daklinza is not approved for use in people who are pregnant. Daklinza may cause birth defects if a woman takes it while she is pregnant. Daklinza is not approved for use in people who are breastfeeding.

Daklinza is not approved for use in people with liver failure. Daklinza may cause liver problems, including liver failure, in some people who take it.

Daklinza is not approved for use in people with a history of serious liver problems. Daklinza may cause serious liver problems, including liver failure, in some people who take it.

Daklinza is not approved for use in people who have had a serious allergic reaction to daclatasvir or any other hepatitis C virus (HCV) drug.

Daklinza is not approved for use in people who have had a heart attack.

Daklinza is not approved for use in people who have had a stroke.

Daklinza is not approved for use in people who have had a blood clot in the lung (pulmonary embolism).

Daklinza is not approved for use in people who have had a heart attack or a stroke.

Side Effects

The most common side effects of Daklinza are nausea, vomiting, diarrhea, and fatigue. Less common side effects include liver problems, blood clots, and a decrease in white blood cells.

Precautions

There are no specific precautions to take when taking Daklinza. However, as with all medications, it is important to discuss any potential side effects with your doctor.

Dosage

The recommended dosage of Daklinza is one pill taken once a day with food.

Storage

Daklinza can be stored at room temperature.

Interactions

Interactions of Daklinza with other medications:

Daklinza should not be used in combination with other hepatitis C medications because the interactions could be dangerous.

Interactions of Daklinza with other drugs:

Daklinza should not be used in combination with other drugs that could increase the risk of liver damage. This includes alcohol, illicit drugs, and medications that can interact with the liver.

Daklinza should also not be used in combination with other medications that could increase the risk of HIV infection, such as ritonavir, nevirapine, efavirenz, amiodarone, angiotensin converting enzyme inhibitors (ACE inhibitors), and angiotensin receptor blockers (ARBs).

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Frequently Asked Questions (FAQs)