SOFOSBUVIR,DACLASTAVIR

Background and Date of Approval

Daclatasvir received FDA approval on July 24, 2015, and sofosbuvir received FDA approval on December 6, 2013, for the treatment of chronic hepatitis C virus (HCV) infection.

Uses

Daclatasvir and Sofosbuvir are used in the treatment of chronic hepatitis C virus (HCV) infection.

How is it administered?

Take Daclatasvir and Sofosbuvir exactly as prescribed by your doctor. The recommended dose and dosing schedule may vary depending on your medical condition, age, weight, and other factors. It should be taken with food. Swallow the tablet as a whole with a glass of water. Patients should not chew, crush, or break the tablet, as this may affect the effectiveness of the medication. Avoid doubling the dose to compensate for the missed dose.

Side Effects

Daclatasvir and Sofosbuvir's most common side effects include headache, fatigue, nausea, and insomnia. Other common side effects may include diarrhea, muscle aches, and irritability. Some patients may experience more serious side effects, such as liver problems, allergic reactions, or anemia.

Warnings

Daclatasvir and Sofosbuvir can cause serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These reactions can be life-threatening. Patients with advanced liver cirrhosis may have an increased risk of liver failure or other serious complications during treatment with this medicine. In some cases virus develops resistance to these medications, and treatment may become less effective.

Precautions

Patients who develop skin reactions require immediate medical attention if they occur. Cirrhosis patients require additional monitoring or treatment modifications to minimize the risk of complications. Patients who do not respond to Daclatasvir and Sofosbuvir may require alternative treatment options.

Word of Advice

If you have been prescribed Daclatasvir and Sofosbuvir, it is important to follow your doctor's instructions carefully. Should you experience any unusual symptoms or side effects while taking this medicine—such as fever, persistent cough, difficulty breathing, abdominal pain, or signs of liver dysfunction—contact your doctor immediately. Do not discontinue medication without consulting your doctor first, as doing so may compromise the effectiveness of treatment and your clinical outcomes. Pregnant women and those who are breastfeeding should consult a healthcare provider before commencing this medication. Special caution is warranted when this medication is used in elderly patients and paediatric populations. Minimise close contact with infected persons, as this medication may lower immune function. Maintain a healthy and balanced diet to support your overall health and well-being.

References

Bristol-Myers Squibb Company, US Food and Drug Administration, [Revised on Feb 2017] [Accessed on 12th May 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s006lbl.pdf Gilead Sciences Ireland UC, European Medical Agency (ema), [Revised on Sept 2018] [ Accessed on 12th May 2023], https://www.ema.europa.eu/en/documents/product-information/sovaldi-epar-product-information_en.pdf Gilead Sciences, US Food, and Drug Administration, [ Revised on August 2015] [ Accessed on 12th May 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf

Frequently Asked Questions

Can Daclatasvir and Sofosbuvir be used in patients with kidney disease?

Daclatasvir and Sofosbuvir can be used in patients with kidney disease, but the dose may need to be adjusted based on the patient's kidney function. Patients with severe kidney disease may require close monitoring during treatment.

Can Daclatasvir and Sofosbuvir cure hepatitis C completely?

Daclatasvir and Sofosbuvir can cure hepatitis C in most cases. Still, the success of the treatment depends on various factors, such as the genotype of the virus, the severity of the liver damage, and the patient's overall health.

Can Daclatasvir and Sofosbuvir be used in patients with HIV?

Daclatasvir and Sofosbuvir can be used in patients with HIV who also have hepatitis C. However, the treatment regimen may differ from those used for patients with hepatitis C alone, and additional monitoring may be required.

Can Daclatasvir and Sofosbuvir be used in patients with cirrhosis?

Daclatasvir and Sofosbuvir can be used in patients with cirrhosis caused by hepatitis C. Still; the treatment may need to be customized based on the severity of the cirrhosis and other factors. Close monitoring is typically required for patients with cirrhosis.

Can Daclatasvir and Sofosbuvir be used in elderly patients?

Daclatasvir and Sofosbuvir can be used in elderly patients. Still, the treatment plan may need to be adjusted based on factors such as kidney function, liver function, and other medical conditions. Close monitoring may be required for elderly patients during treatment.

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS