Sofosbuvir + Daclatasvir (Sofokast Plus) 400 + 60 mg, 28 tablets: profile, composition and research
Reference page for Sofosbuvir + Daclatasvir (Sofokast Plus) 400 + 60 mg, 28 tablets. Active substance: Софосбувир + даклатасвир / Sofosbuvir + daclatasvir.
- What it is: two direct-acting antivirals for the treatment of chronic hepatitis C.
- Presentation: tablets with 400 mg sofosbuvir and 60 mg daclatasvir, 28 per pack.
- Status: prescription-only medicine.
- Research: controlled studies of combination therapy, links below.
- Where to buy: APV Pharmacy (price and availability there).
Key facts
| Active substances | Sofosbuvir and daclatasvir |
|---|---|
| Form | Tablets |
| Strength | 400 mg sofosbuvir and 60 mg daclatasvir per tablet |
| Pack size | 28 tablets |
| Category | Prescription medicine |
| Article (SKU) | 68991 |
What sofosbuvir and daclatasvir are
These are two direct-acting antiviral agents used together in chronic hepatitis C. Each targets a different viral protein, and both are combined in a single tablet containing 400 mg of sofosbuvir and 60 mg of daclatasvir. A pack holds 28 tablets.
Hepatitis C is an RNA virus that multiplies inside liver cells. Left untreated, a chronic infection damages the liver over years and can lead to cirrhosis. Modern regimens aim to stop the virus from reproducing.
Both substances are prescription medicines. A physician prescribes them after testing, including identification of the viral genotype and an assessment of the liver.
How direct-acting antivirals work
The target of sofosbuvir
Sofosbuvir is a nucleotide analogue. Inside the cell it is converted into an active form and inserted into the growing chain of viral RNA, after which the viral enzyme, RNA polymerase, cannot continue. Reproduction of the virus stops.
The target of daclatasvir
Daclatasvir blocks the NS5A protein. The virus needs it to assemble new copies and to build the membranous factories where replication takes place. Without working NS5A the virus cannot produce intact offspring.
Why two targets at once
The virus accumulates mutations quickly. When pressure falls on a single protein, resistant variants survive more easily. Suppressing two separate stages at the same time makes such variants less likely to emerge.
Why the regimen is chosen individually
The viral genotype matters: different variants respond differently to combinations, and for some of them a third component such as ribavirin is added. The decision is made by a physician on the basis of test results.
The state of the liver is also taken into account, along with cirrhosis, previous treatment and other illnesses. For some groups, for example people with advanced liver damage, the regimen and its length differ.
During treatment the amount of virus in the blood is monitored, which shows whether the patient is responding. Changing medicines or interrupting the course on one's own is not acceptable.
What the research shows
A study published in the New England Journal of Medicine in 2014 examined the daclatasvir and sofosbuvir combination in previously treated and untreated patients with chronic hepatitis C. It reported a high rate of sustained virological response among participants.
The ALLY-3 trial (Hepatology, 2015) looked at patients with genotype 3 receiving a 12-week course. A separate study, ALLY-3+ (Hepatology, 2016), examined the same combination with added ribavirin in genotype 3 with advanced liver disease.
A review in Alimentary Pharmacology & Therapeutics (2015) summarised the daclatasvir data. Overall the research indicates that direct-acting combinations change the course of the disease, yet the outcome depends on genotype, stage of liver damage and adherence, so conclusions are drawn for the individual patient.
Published research
Primary sources, verified against PubMed:
- Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection., PubMed 24428467 (N Engl J Med, 2014).
- All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study., PubMed 25614962 (Hepatology, 2015).
- Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+)., PubMed 26822022 (Hepatology, 2016).
- Review article: the efficacy and safety of daclatasvir in the treatment of chronic hepatitis C virus infection., PubMed 26014906 (Aliment Pharmacol Ther, 2015).
Listed for reference. Publication of a study is not a claim about this particular product.
Precautions
- These are prescription medicines. The regimen, its length and any additional agents are chosen by a physician.
- The combination is used in chronic hepatitis C; it does not replace specialist follow-up and laboratory monitoring.
- During treatment the viral level and liver values are checked, along with general wellbeing.
- Headache, nausea and tiredness are possible. Marked symptoms should be reported to a doctor.
- Pregnancy and breastfeeding call for a separate discussion with a physician, and other measures may be added.
- Tell your doctor about every other medicine you take: interactions can influence which regimen is suitable.
Frequently asked
Are sofosbuvir and daclatasvir prescription medicines?
Yes. They are prescription antivirals and are prescribed by a physician.
For which condition are they considered?
Chronic hepatitis C. The choice of regimen depends on the viral genotype and the state of the liver.
Why does this page not give a dosing schedule?
The dose, duration and composition of the regimen are set by a physician from test results and response. A reference page does not prescribe treatment.
Where does the order ship from?
Shipping and customs handling are described on the APV Pharmacy delivery page.