Brand Name : Resof Total
Active components : Sofosbuvir & Velpatasvir
Strength of the components : 400mg & 100mg respectively
Package : 28 tablets in a container
Manufactured by: Dr. Reddy’s
Classified as: Anti-viral drugs
Resof Total 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. Resof Total is the FDA approved product, which is used in chronic HCV condition. Resof Total 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. Resof Total tablets are recommended for chronic condition of hepatitis C viral infection related to genotype 1, 2, 3, 4, 5 or 6. The dosing of Resof Total; The usual recommended dose of Resof Total is, one tablet should be administered orally as a single dose. Resof Total 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 Resof Total is;
Sofosbuvir at 0.5 to 1 hour & Velpatasvir at 3 hours Food does not affect the absorption of Resof Total
The Resof Total 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 Resof Total metabolism is majorly occurs in liver; sofosbuvir by cathepsin A or carboxyl esterase 1 & Velpatasvir by CYP2B6, CYP2C8 or CYP3A4.
Resof Total excretion occurs via;
Sofosbuvir by urine (80%), feces (14%) & exhaled air (2.5%) & Velpatasvir by urine (88%) & feces (6.6%)
The half lives of Resof Total;
Sofosbuvir 0.4 hour; GS-331007 27 hours & Velpatasvir 15 hours
This adverse occurs by combination of Resof Total 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 Resof Total with P-gp inducers
The concurrent use of Resof Total with P-gp inducers causes loss of therapeutic activity of Resof Total.
Embryo fetal damage due to combination of Resof Total with ribavirin
Fetal damage condition is due to the concomitant use of Resof Total with ribavirin during pregnancy period.
Patients suffered with compensated cirrhosis or without cirrhosis; One tablet of Resof Total should be administered orally as once daily over period of 12 weeks. Patients suffered with decompensated cirrhosis; One Resof Total 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; Resof Total tablets dosage adjustment should not be recommended.
Resof Total tablets are combined with P-gp inducers either potent or moderate, causes loss of activity of Resof Total by decreasing the sofosbuvir plasma concentration. Resof Total tablets co administered with P-gp or BCRP inhibitors, leads to increase the exposure of adverse effects of these substrates. Resof Total combined with warfarin causes variation in both prothrombin time & INR values. Resof Total co administered with acid reducing agents causes decreasing the effect of concentration of sofosbuvir & Velpatasvir leads to loss of activity of Resof Total. Resof Total tablets combined with amiodarone leads to cause bradycardia. Resof Total tablets co administered with anti-convulsants, or anti-mycobacterials, causes decreasing concentration of sofosbuvir & Velpatasvir. Resof Total with st Johns wort causes losing the anti-viral activity of Resof Total by decreasing the concentration of either sofosbuvir or Velpatasvir. Resof Total combined with HMG CoA reductase inhibitors causes increasing the concentration of these drugs.
Warning should be provided to the patients receiving Resof Total
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.
Resof Total 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 Resof Total.
Breast feeding should not be suggested
The safety & effectiveness of Resof Total should not be evaluated for pediatric patients.
In geriatric patients, no dosage adjustment of Resof Total should be recommended.
Fetal damage condition is due to the concomitant use of Resof total with ribavirin during pregnancy period.
Fatigue, Nausea, Asthenia, Insomnia, Irritability, Headache.
Lipase elevation, Increased creatine kinase, Increased bilirubin levels.
Post marketing effects
Cardiac disorders, Rashes, Angioedema.