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Daclatasvir+sofosbuvir

About Daclatasvir+sofosbuvir

Daclatasvir+sofosbuvir is a prescription antiviral medicine used to treat chronic hepatitis C, a long-term viral infection that affects the liver. It is used to clear the hepatitis C virus from your blood and reduce the risk of long-term liver damage. It is prescribed according to your hepatitis C virus (HCV) genotype, liver condition, previous treatment history, and other individual factors.

For this medicine to work effectively, take it once daily at the same time each day, with or without food, exactly as prescribed by your doctor. Treatment is usually given for 12 weeks, but some people may need a longer course, such as 24 weeks, depending on factors including cirrhosis and previous treatment. Your doctor will determine the appropriate treatment duration and regimen for you.

Some people may experience mild side effects, including headache, fatigue, nausea, or diarrhoea. Serious symptoms are uncommon, but seek medical attention if you develop severe dizziness, fainting, chest pain, shortness of breath, or signs of a serious allergic reaction.

Before you begin taking this medicine, tell your doctor about your complete medical history. Do not take this medicine if you have had a severe allergic reaction to daclatasvir, sofosbuvir, or any other ingredient in the formulation. It is also important to tell your doctor if you have ever had hepatitis B, as hepatitis B can become active again during treatment with medicines for hepatitis C.

This medicine can interact with several other medicines, including certain heart medicines, seizure medicines, antibiotics, and herbal supplements such as St John's wort. These interactions can reduce the effectiveness of treatment or increase the risk of side effects. If you are pregnant, planning to become pregnant, breastfeeding, or are an older adult, tell your doctor before starting treatment so that your treatment can be assessed appropriately.

Uses of Daclatasvir+sofosbuvir

Daclatasvir+sofosbuvir is used in the treatment of chronic Hepatitis C virus infection. The detailed uses of Daclatasvir+sofosbuvir are as follows: • Chronic Hepatitis C virus infection treatment: Daclatasvir+sofosbuvir targets and inhibits viral replication proteins to treat chronic Hepatitis C virus (HCV) infection. • Liver Protection: Daclatasvir+sofosbuvir guards against serious liver damage and lowers inflammation in the liver.

Medicinal Benefits

When used as directed as part of your treatment plan, Daclatasvir+sofosbuvir may provide the following benefits:

  • Helps clear the virus: By blocking different stages of hepatitis C virus replication, Daclatasvir+sofosbuvir can reduce the amount of virus in the body and help achieve sustained viral clearance.
  • Helps protect the liver: Successful treatment of chronic hepatitis C can reduce ongoing viral damage to the liver and lower the risk of long-term complications such as cirrhosis and liver-related complications.
  • Convenient oral treatment: Daclatasvir+sofosbuvir is taken by mouth, providing a tablet-based treatment option without the need for interferon injections.

Directions for Use

  • Daclatasvir+sofosbuvir can be taken with or without food or as advised by your doctor.
  • Follow your doctor's instructions on the dosage and timing of this medication.
  • Swallow Daclatasvir+sofosbuvir as a whole with a glass of water.
  • Do not break, crush, or open it.

Storage

Store in a cool and dry place away from sunlight

Side Effects of Daclatasvir+sofosbuvir

Common Side Effects (Usually mild):

  • Headache
  • Feeling unusually tired or weak (fatigue)
  • Nausea
  • Diarrhoea or upset stomach


Serious Side Effects (Consult your doctor right away):

  • An unusually slow heart rate, particularly if you are also taking amiodarone or certain other heart medicines
  • Severe dizziness, lightheadedness, or fainting
  • Chest pain or shortness of breath
  • Signs of a serious allergic reaction, including severe skin rash, hives, itching, or swelling of the face, lips, tongue, or throat

 

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Drug Warnings

  • Check for hepatitis B: Get tested for hepatitis B before starting treatment if your doctor recommends it, because hepatitis B can become active again during treatment for hepatitis C.
  • Take every dose: Do not skip doses or stop treatment early, even if you feel better. Missing doses or stopping treatment without medical advice may reduce the chance of successfully clearing the virus.
  • Check before starting new medicines: Tell every doctor, dentist, or pharmacist treating you that you are taking Daclatasvir+sofosbuvir before starting any new medicine, including over-the-counter medicines, supplements, or herbal products.
  • Check acid-reducing medicines: If you take medicines for indigestion, heartburn, or acid reflux, tell your doctor or pharmacist. Some acid-reducing medicines can affect the absorption of daclatasvir, so you may need specific instructions about timing.
  • Check your HCV genotype and liver condition: The treatment regimen and duration are not the same for everyone. Your doctor will determine the appropriate treatment based on your HCV genotype, liver condition, previous treatment, and other factors.
  • Do not change the regimen yourself: Some people, particularly those with certain HCV genotypes or cirrhosis, may need a different regimen or an additional medicine such as ribavirin. Follow your doctor's treatment plan exactly.
  • Know when to seek help: Consult your doctor right away if you develop severe dizziness, fainting, chest pain, shortness of breath, or symptoms of a serious allergic reaction.

Drug Interactions

  • Amiodarone: Taking amiodarone with sofosbuvir-containing treatment can cause serious symptomatic slowing of the heart rate. Your doctor may recommend an alternative treatment or close heart monitoring if these medicines need to be used together.
  • Anticonvulsants (e.g., carbamazepine, phenytoin): These medicines can reduce the levels of daclatasvir or sofosbuvir and may make hepatitis C treatment less effective. Tell your doctor if you take medicines for seizures.
  • Rifampicin and other rifamycin antibiotics (e.g., rifabutin): These medicines can lower daclatasvir levels and may reduce the effectiveness of treatment. Your doctor may need to choose an alternative antibiotic or hepatitis C regimen.
  • St John's wort: This herbal medicine can reduce the levels of daclatasvir and may make the treatment less effective. Do not take St John's wort unless your doctor specifically advises you to do so.
  • Other medicines: Tell your doctor or pharmacist about all prescription medicines, over-the-counter medicines, vitamins, and herbal supplements you take before starting treatment, as additional interactions may need to be checked.

Drug-Drug Interactions Checker List:

  • RIFAMPICIN
  • CLARITHROMYCIN
  • RITONAVIR
  • ATAZANAVIR
  • EMTRICITABINE
  • WARFARIN
  • PHENYTOIN
  • CARBAMAZEPINE
  • OXCARBAZEPINE
  • PHENOBARBITAL
  • ROSUVASTATIN
  • DEXAMETHASONE
  • AMIODARONE
  • DIGOXIN
  • Safety Advice

    • Safety Warning

      Alcohol

      consult your doctor

      It is not known if Daclatasvir+sofosbuvir interacts with alcohol. Please consult your doctor.

    • Safety Warning

      Pregnancy

      unsafe

      Daclatasvir+sofosbuvir should not be taken by pregnant women or by women of reproductive age who are not taking contraception. For five weeks following the completion of treatment with Daclatasvir+sofosbuvir, the use of highly effective contraception should be maintained.

    • Safety Warning

      Breast Feeding

      caution

      It is unknown whether Daclatasvir+sofosbuvir passes into breast milk. Therefore, you should avoid breastfeeding while undergoing treatment with Daclatasvir+sofosbuvir. Please consult your doctor for advice.

    • Safety Warning

      Driving

      caution

      Daclatasvir+sofosbuvir may cause dizziness. Do not drive or operate heavy machinery if you are not fully alert.

    • Safety Warning

      Liver

      caution

      Daclatasvir+sofosbuvir does not need to be dosage adjusted for patients with mild, moderate, or severe liver impairment. In patients with decompensated cirrhosis, the safety and effectiveness of this medicine have not been proven.

    • Safety Warning

      Kidney

      caution

      It is not necessary to change the dosage of Daclatasvir+sofosbuvir for patients with mild to moderate kidney impairment. In patients with end-stage kidney disease (ESRD) requiring hemodialysis or severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2), the safety and dosage of sofosbuvir have not been determined.

    • Safety Warning

      Children

      unsafe

      Daclatasvir+sofosbuvir is not recommended for use in children below 18 years of age, as its efficacy and safety have not been established in this age group.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Avoid alcohol: Avoiding alcohol is advisable during hepatitis C treatment because alcohol can contribute to liver damage and may worsen existing liver disease.
    • Eat a balanced diet: Choose a varied diet containing vegetables, fruits, whole grains, and suitable sources of protein while limiting highly processed foods and excessive amounts of saturated fat and added sugar.
    • Stay hydrated: Drink enough fluids throughout the day unless your doctor has advised you to restrict your fluid intake.
    • Practise safe hygiene: Do not share personal items that may contain blood, such as razors, toothbrushes, or nail clippers.
    • Prevent blood exposure: Avoid sharing needles or other equipment that may come into contact with blood. Discuss safer sexual practices with your doctor, particularly if there is a risk of blood exposure.

    Special Advise

    • It is advised to closely monitor liver and kidney function tests while undergoing treatment with Daclatasvir+sofosbuvir.
    • Your healthcare provider will advise blood tests before, during, and after your treatment with Daclatasvir+sofosbuvir to determine which other medications you may need and for how long, as well as to verify the effectiveness of the treatment. 

    Patients Concern

    Disease/Condition Glossary

    HCV (Hepatitis C virus) infection: It is a viral infection that causes inflammation or swelling in the liver, which can lead to serious liver damage. It is caused by the hepatitis C virus (HCV) and spreads through contact when infected blood enters the bloodstream of someone who is not infected. The infection begins with what is called an acute phase, but this phase often goes unnoticed because it usually does not cause any symptoms. If symptoms do appear, they may include yellowing of the skin (jaundice), fatigue, nausea, fever, and muscle aches. If the infection lasts for a long time, it becomes chronic hepatitis C, which can remain symptom-free for many years. Symptoms usually only appear once the virus has caused enough liver damage. These symptoms can include easy bruising or bleeding, extreme fatigue, yellowing of the skin, dark urine, swollen legs, drowsiness, and slurred speech.

    FAQs

    Daclatasvir+sofosbuvir belongs to a class of drugs called antivirals. It is used to treat chronic Hepatitis C virus (HCV) infection.

    Daclatasvir+sofosbuvir contains antiviral drugs daclatasvir and sofosbuvir, which reduce the amount of the virus in the body, which is how they treat chronic hepatitis C (HCV). They function by preventing the activity of two proteins that are necessary for the virus to replicate.

    Daclatasvir+sofosbuvir may cause common side effects, such as nausea, diarrhoea, abdominal pain, difficulty sleeping, dizziness, tiredness, headache, insomnia (sleeplessness), and joint or muscle pain in some cases. These side effects are usually mild and tend to go away on their own without requiring medical treatment. However, if they persist or become more severe, please consult your doctor.

    Yes, hepatitis C virus (HCV) infection is contagious and can spread through contact with the blood of an infected person. To reduce the risk of spreading the virus, it is advised not to share personal items or needles that may have come into contact with an infected individual's blood.

    You should be cautious when using Daclatasvir+sofosbuvir if you are currently taking or have taken amiodarone in the past few months. Contact your doctor immediately if you experience symptoms of a slow heartbeat, such as chest pain, dizziness, fainting, confusion, memory issues, fatigue, weakness, or shortness of breath. If Daclatasvir+sofosbuvir treatment is necessary, you may need additional heart monitoring.

    The treatment duration depends on your HCV genotype, liver condition, whether you have cirrhosis, previous treatment history, and other factors. A course is often 12 weeks, while some people may need 24 weeks. Your doctor will determine the appropriate duration and regimen for you.

    Yes. The effectiveness and recommended treatment regimen can vary according to HCV genotype and your individual clinical situation. Some people, particularly those with genotype 3 or cirrhosis, may need a different treatment duration, an additional medicine such as ribavirin, or another antiviral regimen. Your doctor will choose the most appropriate treatment for you.

    Direct-acting antiviral medicines such as sofosbuvir and daclatasvir can cure hepatitis C in many people by clearing the virus from the body. The chance of cure depends on factors such as your HCV genotype, liver condition, previous treatment, and whether you complete the prescribed regimen. WHO reports that direct-acting antivirals can cure more than 95% of people with hepatitis C overall, although individual treatment outcomes vary.

    Do not automatically take another tablet. Contact your doctor or pharmacist and tell them how long after taking the medicine you vomited. They can advise you whether another dose is needed based on the timing and the specific product you are taking.

    It is advisable to avoid alcohol while being treated for hepatitis C, particularly if you have liver disease. Alcohol can contribute to ongoing liver damage. Talk to your doctor if you need support with stopping or reducing alcohol use.

    Some medicines used for indigestion, heartburn, or acid reflux can affect the absorption of daclatasvir. Do not start or change these medicines without speaking to your doctor or pharmacist. They can advise you about the appropriate medicine and timing.

    If you are pregnant, planning to become pregnant, or breastfeeding, tell your doctor before starting treatment. Your doctor will assess the available treatment options and their potential benefits and risks for your situation.

    Stopping treatment early or frequently missing doses can reduce the chance of clearing hepatitis C and may increase the risk of treatment failure. If you are having difficulty taking your medicine regularly or are considering stopping, speak to your doctor rather than stopping it on your own.

    Successful treatment can clear hepatitis C from your body, but you should continue to take precautions against blood exposure until your doctor confirms that treatment has been successful. Do not share needles, razors, toothbrushes, or other personal items that may contain blood. Talk to your doctor about reducing the risk of transmitting hepatitis C to others.

    If the delay is less than 18 hours, take the missed dose when you remember and then continue with your usual schedule. If more than 18 hours have passed, skip the missed dose and take the next dose at your usual time. Do not take two doses together.

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