Brand Name : Myhep-All
Active components : Sofosbuvir & Velpatasvir
Strength of the components : 400mg & 100mg respectively
Package : 28 tablets in a container
Manufactured by: Mylan pharmaceuticals
Classified as: Anti-viral drugs
Myhep-All is the fixed dose combination of these two most widely used anti-viral agents. Sofosbuvir & Velpatasvir are directly acting anti-viral agents which are involved in the treatment of chronic hepatitis C viral infection. Sofosbuvir is usually combined with other anti-viral agent for exhibiting the prominent effects. Myhep-All is the FDA approved product, which is used in chronic HCV condition. Myhep-All should be used in genotype I, II, III, IV, V or VI associated hepatitis C viral infections.
DOSAGE BEFORE THE TREATMENT
Examine the patients thoroughly, before initiating the treatment with HCV anti-viral agents. Care should be taken while using HCV medication in patients with HCV/HIV-1co infections, in this case HBV reactivation occurs. Myhep-All tablets are recommended for chronic condition of hepatitis C viral infection related to genotype 1, 2, 3, 4, 5 or 6. The dosing of Myhep-All; The usual recommended dose of Myhep-All is, one tablet should be administered orally as a single dose. Myhep-All tablet consist of 100mg of Velpatasvir & 400mg of Sofosbuvir
Sofosbuvir is a NS5B protein inhibitor, protein is essential for viral production. Sofosbuvir is a prodrug form, which get converted into active uridine triphosphate form which is required for anti-viral activity. This dynamic active moiety is get inserted into HCV RNA with the help of NS5B polymerase and leads as chain eliminator. Velpatasvir is pharmacologically acts as NS5A inhibitor; this protein is required for HCV viral production. Velpatasvir is involved its action in viral production process.
The maximum plasma concentration of Myhep-All is;
Sofosbuvir at 0.5 to 1 hour & Velpatasvir at 3 hours Food does not affect the absorption of Myhep-All The Myhep-All tablet is highly bound to human plasma protein is; Sofosbuvir 61 to 65% & Velpatasvir by >99.5%
The blood plasma ratio of;
Sofosbuvir 0.7 & Velpatasvir 0.52 to 0.67. The Myhep-All metabolism is majorly occurs in liver; sofosbuvir by cathepsin A or carboxyl esterase 1 & Velpatasvir by CYP2B6, CYP2C8 or CYP3A4.
Myhep-All excretion occurs via;
Sofosbuvir by urine (80%), feces (14%) & exhaled air (2.5%) & Velpatasvir by urine (88%) & feces (6.6%) The half lives of Myhep-All;
Sofosbuvir 0.4 hour; GS-331007 27 hours & Velpatasvir 15 hours
This adverse occurs by combination of Myhep-All with amiodarone, causes increased concentration of amiodarone leads to severe bradycardia. To overcome the problem by; Stop the combinational treatment ECG monitoring Start alternative medication for reducing the cardiac issues
Loss of activity occurs during concomitant use of Myhep-All with P-gp inducers
The concurrent use of Myhep-All with P-gp inducers causes loss of therapeutic activity of Myhep-All.
Embryo fetal damage due to combination of Myhep-All with ribavirin
Fetal damage condition is due to the concomitant use of Myhep-All with ribavirin during pregnancy period.
Patients suffered with compensated cirrhosis or without cirrhosis; One tablet of Myhep-All should be administered orally as once daily over period of 12 weeks. Patients suffered with decompensated cirrhosis; One Myhep-All tablet should be combined with weight based ribavirin by administering with food for 12 hours. The dose of ribavirin should be calculated for the patients; Patient with <75kg of body weight, the recommended dose of ribavirin is 1000mg administered as twice daily. Patient with at least 75kg of body weight, recommended dose of ribavirin is 1200mg administered as twice daily. For both renal & hepatic impaired patients; Myhep-All tablets dosage adjustment should not be recommended.
Myhep-All tablets are combined with P-gp inducers either potent or moderate, causes loss of activity of Myhep-All by decreasing the sofosbuvir plasma concentration. Myhep-All tablets co administered with P-gp or BCRP inhibitors, leads to increase the exposure of adverse effects of these substrates. Myhep-All combined with warfarin causes variation in both prothrombin time & INR values. Myhep-All co administered with acid reducing agents causes decreasing the effect of concentration of sofosbuvir & Velpatasvir leads to loss of activity of Myhep-All. Myhep-All tablets combined with amiodarone leads to cause bradycardia. Myhep-All tablets co administered with anti-convulsants, or anti-mycobacterials, causes decreasing concentration of sofosbuvir & Velpatasvir. Myhep-All with st Johns wort causes losing the anti-viral activity of Myhep-All by decreasing the concentration of either sofosbuvir or Velpatasvir. Myhep-All combined with HMG CoA reductase inhibitors causes increasing the concentration of these drugs.
Warning should be provided to the patients receiving Myhep-All
The reoccurrence of HBV infection happens in patients who are co infected with HBV/HCV. This may prevented by; Examine the patients HBsAg & anti-HBc levels before initiating the therapy. Liver function test should be examine frequently The health management related to HBV infection should be started.
Myhep-All is contraindicated to pregnancy condition due to concomitant use with ribavirin. Some anaphylactic reactions are acquired during the therapy, while the patients are contraindicated to the component of Myhep-All.
Breast feeding should not be suggested
The safety & effectiveness of Myhep-All should not be evaluated for pediatric patients.
In geriatric patients, no dosage adjustment of Myhep-All should be recommended.
Serious bradycardia occurs due to concomitant use of Velasof with amiodarone:
Fatigue, Nausea, Asthenia, Insomnia, Irritability, Headache.
Lipase elevation, Increased creatine kinase, Increased bilirubin levels.
Post marketing effects
Cardiac disorders, Rashes, Angioedema.