Myhep + MyDekla 12 Weeks
Brand name: Myhep
Active Ingredients(Generic Name) : Sofosbuvir
Company Name: Mylan
Package: 28 tabs/bottle
Strength : 400mg
It is used for the treatment of hepatitis Cvirus (HCV) infection. It has been marketed since 2013. Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to four-fold reduced duration of therapy. Sofosbuvir allows most patients to be treated successfully without the use of peginterferon, an injectable drug with severe side effects. that is a key component of older drug combinations for the treatment of HCV.
Sofosbuvir is used for the treatment of chronic hepatitis C, genotypes 1, 2, 3, and 4, in combination with pegylated interferon and ribavirin, or with ribavirin alone. It is also used in combination with the viral NS5a inhibitor ledipasvir in an interferon-free combination for the treatment of genotype 1 hepatitis C infection. sofosbuvir also used along with the daclatasvir for the genotype 3 indication and also available pangenotypic combination of sofosbuvir and velpatasvir. Sofosbuvir is also used in HCV patients with an HIV coinfection. The treatment is based on a number of clinical trials, for example the ELECTRON trial which showed that a dual interferon-free regimen of sofosbuvir plus ribavirin produced a 24-week post-treatment sustained virological response (SVR24) rate of 100% for previously untreated patients with HCV genotypes 2 or 3.
Mechanism of action:
Sofosbuvir contains oral nucleotide analog inhibitor of the hepatitis C virus (HCV) polymerase. The drug is a direct-acting antiviral agent and interferes straight with the HCV lifecycle, restraining the viral replication. It can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. The drug is available for oral use in the form of 400mg tablets.
Dosage and Administration:
The recommended daily dose of Sofosbuvir is 400mg tablet to be taken once daily with or without food. Sofosbuvir should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC (Chronic Hepatitis C) in adults. It is highly advisable to administer the drug under strict medical supervision and advice.
Adverse events associated with the use of Sofosbuvir in combination with Ribavirin may include, but are not limited to, the following
o Fatigue , headache
Adverse events associated with the use of Sofosbuvir in combination with Peginterferon Alfa and Ribavirin may include, but are not limited to, the following:
o fatigue,headache, nausea, insomnia, anemia
Precaution: Safety and efficacy have not been established in patients younger than 18 years. Consult WARNINGS section for additional precautions.
MYDEKLA ( DACLATASVIR)IS A NS5A REPLICATION COMPLEX INHIBITOR.
MyDekla ( Daclatasvir)is specifically indicated for use with sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) of genotype 1, 3, or 4 infections. The other medications used in combination include sofosbuvir, ribavirin, and interferon, vary depending on the virus type and whether the person has cirrhosis.
MyDekla ( Daclatasvir) stops HCV viral RNA replication and protein translation by directly inhibiting HCV protein NS5A. NS5A is critical for HCV viral transcription and translation,
MyDekla ( Daclatasvir)is supplied as tablets for oral administration. It is taken by mouth once a day. The recommended dose is 60 mg taken orally once daily with or without food in combination with sofosbuvir. The recommended treatment duration is 12 weeks. Dose modification: reduce dosage to 30 mg once daily with strong CYP3A inhibitors and increase dosage to 90 mg once daily with moderate CYP3A inducers.
Concomitant use of drugs that are strong inducers of the cytochrome P450 CYP3A is contraindicated due to decreased therapeutic effect and resistance of drug. Some common drugs that are strong CYP3A inducers include dexamethasone, phenytoin, carbamazepine, rifampin and St. John's Wort.
MyDekla ( Daclatasvir) is a CYP3A and p-glycoprotein substrate, therefore, drugs that are strong inducers or inhibitors of these enzyme will interfere with daclatascir levels in the body. Dose modifications are made with concomitant use of daclatasvir and drugs that affect CYP3A or p-gp. When taking daclatasvir with non-nucleoside reverse transcriptase inhibitors, the dose of daclatasvir is increased to overcome CYP3A induction. The dose for daclatasvir should be lowered when taking with antifungals, such as ketoconazole. Currently, there are no required dosage adjustments with concurrent use of daclatasvir and immunosuppressants, narcotic analgesics, antidepressants, sedatives, and cardiovascular agents.
Concurrent use with amiodarone, sofosbuvir and daclatasvir has may result in an increased risk for serious slowing of the heart rate.
Common side effects with sofosubvir and daclatasvir include headache, feeling tired, and nausea. With daclatasvir, sofusbivir, and ribavirin the most common side effects are headache, feeling tired, nausea, and red blood cell breakdown. It should not be used with St. John's wort, rifampin, or carbamazepine. It works by inhibiting the HCV protein NS5A.
It is on the World Health Organization's List of Essential Medicines