

Velakast 400mg Tablet (Velpatasvir and Sofosbuvir)
Manufactured By
Aprazer Healthcare Pvt Ltd
Pack Of
28
Salt Composition
Velpatasvir and Sofosbuvir
Storage
Below 30°C
Overview
Velakast 400mg Tablet combines sofosbuvir 400 mg, an HCV NS5B nucleotide polymerase inhibitor, with velpatasvir 100 mg, a pan-genotypic NS5A inhibitor. It is a direct-acting antiviral (DAA) regimen used to cure chronic hepatitis C across major HCV genotypes. Treatment selection depends on cirrhosis status, prior DAA exposure, renal function, drug interactions, and, in decompensated cirrhosis, whether ribavirin can be used. The regimen is usually one tablet once daily under strict doctor supervision.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | Velakast |
| Molecule / Combination | Sofosbuvir 400 mg + Velpatasvir 100 mg |
| Strength / Composition | 400mg/100mg |
| Dosage form | Tablet |
| Manufacturer / Marketer | Aprazer Healthcare Pvt Ltd |
| Pack / Presentation | 28 tablets |
| Storage | Below 30°C. |
| Prescription | Required |
Uses and Indications
Velakast 400mg Tablet is used in the treatment of:
- Chronic hepatitis C (HCV) infection
Sofosbuvir 400mg tablets are an antiviral therapy that prevents the replication of HCV and enables the immune system to get rid of the virus. In patients who have never been treated before for HCV and do not have cirrhosis or compensated cirrhosis, the treatment usually takes 12 weeks. However, for patients who have decompensated cirrhosis, the therapy requires 12 weeks plus ribavirin. Also, before the treatment, patients are screened for hepatitis B due to the reactivation of the virus by the drug.
How Velakast 400mg Tablet Works
Sofosbuvir tablet is converted into an active drug in the body and inhibits NS5B, which is an enzyme required by HCV to replicate its RNA. This prevents replication of the virus. On the other hand, Velpatasvir 100mg tablet inhibits NS5A, which is required for replication of the RNA and formation of new virus particles. However, both drugs prevent multiplication of HCV.
Clinical Evidence for Velakast 400mg Tablet
ASTRAL-1 to ASTRAL-4: In these extensive clinical trials, it was evident that Velakast 400mg Tablet had the potential to attain sustained viral response in patients with various HCV genotypes and varying degrees of cirrhosis.
Real-world evidence: High rates of cure have been found through studies that involved patients who received treatment in their usual health care environment.
Side Effects of Velakast 400mg Tablet
Velpatasvir 100 mg tablet is a safe medication; however, there might be some adverse effects on the health of some individuals. These might range from mild adverse effects to those requiring medical treatment. Some common side effects include:
Common side effects
- Headache
- Fatigue
- Nausea
Serious side effects
- Serious bradycardia with amiodarone-containing regimens
- HBV reactivation
- Drug-interaction-related virologic failure
Critical Safety Warning
AMIODARONE AND HBV WARNING: The treatment regimen including Sofosbuvir 400 mg may result in bradycardia (slow heart rate) if used together with amiodarone; thus, the two medications should not be used together unless under the supervision of a specialist. Testing for HBV should also be performed prior to treatment since the virus may be reactivated.
Velakast 400mg Tablet Dosage and How To Take It
Important: Dose and regimen must be prescribed by the treating specialist. Tablet/vial strength is not necessarily the patient dose. Do not start, stop, split, combine, or substitute treatment based on website information.
| Clinical situation | Dose |
|---|---|
| Typical regimen | One tablet once daily for 12 weeks in many treatment-naïve patients without decompensated cirrhosis. |
| Decompensated cirrhosis | Usually requires specialist regimen selection, often Sofosbuvir 400 mg plus ribavirin for 12 weeks under the reference label. |
| Food | Velakast 400mg Tablet can be taken with meals or on an empty stomach. |
| Acid suppression | The antacids, H2 blockers, and proton pump inhibitors (PPIs) have the potential to decrease the absorption of the velpatasvir 100mg tablet. |
Velakast 400mg Tablet Missed Dose
Take a missed dose as soon as remembered if it is not close to the next dose; do not double. Adherence is important to maximize cure and prevent treatment failure.
Safety Advice for Velakast 400mg Tablet
| Category | Status | Guidance |
|---|---|---|
| HBV | Screen/monitor | Testing for hepatitis B prior to therapy is important since it can reactivate during or after HCV therapy. |
| Liver | Stage disease | Decompensated cirrhosis could affect the treatment plan and requires more monitoring. |
| Pregnancy | Combination-dependent | There is no sufficient data on pregnancy with the Velakast 400mg Tablet. However, ribavirin should not be used during pregnancy, as it may lead to serious damage to the fetus. |
| Driving | Usually minimal | Fatigue or headache may occur. Avoid driving if these symptoms affect alertness. |
Monitoring During Velakast 400mg Tablet Treatment
- It is important that HCV RNA be tested during appropriate times to determine the effectiveness of the treatment in removing the hepatitis C virus.
- HBV testing is recommended prior to therapy due to the possible reactivation of hepatitis B.
- Liver disease stage needs to be evaluated due to the possibility of advanced liver disease.
- Drug interactions are necessary in order to avoid complications due to other drugs.
- Evaluation of kidney function may be necessary depending on the condition of the patient.
- Adherence needs to be determined in order to finish the treatment course properly.
Velakast 400mg Tablet Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Velakast |
| Generic / Combination | Sofosbuvir 400 mg + Velpatasvir 100 mg |
| Strength | 400mg/100mg |
| Form | Tablet |
| Manufacturer / Marketer | Aprazer Healthcare Pvt Ltd |
| Pack | 28 tablets |
| Storage | Below 30°C. |
| Major safety theme | AMIODARONE AND HBV WARNING |
| Prescription | Yes |
Velakast 400mg Tablet Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Amiodarone | Severe bradycardia risk | Avoid combinations where possible. |
| PPIs/H2 blockers/antacids | Reduce velpatasvir absorption | Follow precise timing/dose limits. |
| Strong P-gp/CYP inducers such as rifampicin/carbamazepine | Reduce antiviral exposure | Avoid these medicines with the treatment. |
| Certain statins | Increased statin exposure | Follow dose limits and watch for muscle pain or weakness. |
FAQs About Velakast 400mg Tablet
Does Velakast 400mg tablet cure hepatitis C?
Yes. Most of the time, Velakast 400mg tablets can help eliminate the hepatitis C virus. However, a cure is considered achieved once there is zero HCV RNA after treatment.
What is the duration of Sofosbuvir 400 mg treatment?
Treatment usually takes up to 12 weeks, but it may vary based on liver status, presence of cirrhosis, and hepatitis C therapy done previously.
Why do I need to test for hepatitis B before taking Velakast 400mg?
The reason why hepatitis B needs to be tested prior to treatment is that HBV can reactivate while undergoing treatment for hepatitis C.
Can I take PPI together with Velpatasvir 100 mg?
Proton pump inhibitors decrease the bioavailability of velpatasvir. Therefore, it is important to follow the timing and dose as directed by the physician.
Is it possible to take the Velakast 400mg tablet with food?
Yes, it is possible. Velpatasvir 100 mg tablets can be taken with or without food at the fixed time every day.
Why is it bad to take amiodarone along with a Sofosbuvir 400 mg tablet?
Amiodarone taken in combination with a sofosbuvir tablet may result in a significantly slower heart rate. In general, such a combination should be avoided.
When can one declare a cure after using the Velakast 400mg tablet?
HCV RNA is usually checked after the therapy is finished for 12 weeks. The absence of the virus during this time means that there is an SVR12 (virologic cure).
References
- Current sofosbuvir/velpatasvir prescribing information (Epclusa/reference) https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf
- Feld JJ, et al. ASTRAL-1. New England Journal of Medicine https://pubmed.ncbi.nlm.nih.gov/26571066/
- Curry MP, et al. ASTRAL-4. New England Journal of Medicine https://www.nejm.org/doi/full/10.1056/NEJMoa1512614
- Current AASLD-IDSA/EASL HCV guidance https://www.idsociety.org/practice-guideline/hcv-guidance/
Marketer Details
Aprazer Healthcare Pvt Ltd
Disclaimer
Globanspharma main goal is to ensure that its consumers get correct, authentic, and reliable information that has been examined by medical professionals. This website's content has only been created for informational purposes. However, this is not meant to replace the medical advice and treatment given by a qualified physician. The information presented herein may not cover everything about particular lab tests, medicines, and health conditions, all possible side effects, and warnings. Please discuss all your queries related to any medication and illness with your doctor. We intend to support and maintain the doctor-patient relationship, not to substitute it or take its place.


