Velakast (Sofosbuvir + Velpatasvir) 400+100 mg, 28 tablets: profile, composition and research

Reference page for Velakast (Sofosbuvir + Velpatasvir) 400+100 mg, 28 tablets. Active substance: Софосбувир + Велпатасвир / Sofosbuvir + Velpatasvir.

Key facts

What sofosbuvir and velpatasvir are

Sofosbuvir with velpatasvir is a fixed-dose direct-acting antiviral combination for chronic hepatitis C. Both substances act against the same virus, but at different stages of its replication, which is why they are combined in a single tablet.

Each tablet holds a fixed combination: 400 mg of sofosbuvir and 100 mg of velpatasvir. A pack of 28 tablets matches one standard course.

Sofosbuvir is a nucleotide inhibitor, velpatasvir is an NS5A inhibitor. The combination is described as pangenotypic because it covers the main virus genotypes, one through six.

How the combination works

Sofosbuvir halts RNA copying

Sofosbuvir is a prodrug: inside the cell it is converted into an active form that is inserted into the growing chain of viral RNA and terminates it. The virus cannot finish copying its genome.

Velpatasvir disrupts particle assembly

Velpatasvir suppresses the NS5A protein, which the virus needs to assemble new particles and prepare them to leave the cell. Without that protein, replication is disrupted at a later stage.

Two points of attack

Combining the two mechanisms makes survival harder for the virus: genome copying and particle assembly are broken at the same time. That is why one medicine can work across different genotypes.

Approved uses

The product information names treatment of adults with chronic hepatitis C virus infection of genotypes 1, 2, 3, 4, 5 and 6 — both without cirrhosis and with compensated cirrhosis. In decompensated cirrhosis the combination is used together with ribavirin.

The manufacturer notes that the combination is not recommended in severe renal impairment, because in such patients the concentration of the sofosbuvir metabolite can rise substantially.

Prescribing, the length of the course and the need to add a second medicine are decided by a physician, usually a hepatologist or an infectious-disease specialist. They also follow liver tests and viral load.

What the research shows

Sofosbuvir with velpatasvir was studied in large programmes that enrolled patients with different genotypes and with cirrhosis. Those studies reported high rates of undetectable viral load in a large share of participants.

Separate studies looked at decompensated cirrhosis and at patients for whom earlier treatment had failed. In those situations the combination with ribavirin, or other regimens, was more often used.

Meta-analyses support the overall efficacy profile but stress that the outcome depends on genotype, liver status and previous treatment. There is no universal forecast for an individual patient.

Published research

Primary sources, verified against PubMed:

• Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection., PubMed 26571066 (The New England journal of medicine, 2015).
• Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection., PubMed 26575258 (The New England journal of medicine, 2015).
• Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis., PubMed 26569658 (The New England journal of medicine, 2015).
• Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis., PubMed 36281168 (Medicine, 2022).

Listed for reference. Publication of a study is not a claim about this particular product.

Precautions

• This is a prescription medicine. Treatment is prescribed by a physician, taking the virus genotype and liver status into account.
• Use together with amiodarone carries a risk of severe slowing of the heart rhythm. Such medicines must be reported to the doctor.
• It is not recommended in severe renal impairment because of accumulation of the sofosbuvir metabolite.
• Viral load and liver function are checked before treatment and during it.
• In pregnancy and breastfeeding the decision belongs to a physician; when combined with ribavirin, extra precautions are needed.
• Tell the doctor about every medicine and herbal product you take: interactions that affect drug levels are possible.

Frequently asked