Introduction for Panovir (Sofosbuvir Velpatasvir) 400 MG – 28 TABLETS :

Panovir represents a paradigm shift in Hepatitis C treatment, challenging traditional techniques with its novel combination of Sofosbuvir and Velpatasvir. Panovir (Sofosbuvir and Velpatasvir) offers a holistic treatment for Hepatitis C patients with various genotypes, demonstrating Incepta’s ongoing dedication to medical progress.
Hepatitis C has long been a difficult disease to treat due to its diverse genotypes and the possibility of resistance to standard treatments. Panovir confronts these difficulties head on with its combination of Sofosbuvir and Velpatasvir, providing a robust therapy alternative that works across genotypes without the requirement for genotyping testing. Incepta Pharmaceuticals Limited manufactures Panovir Tablet 400 mg + 100 mg. Each panovir tablet comprises of Sofosbuvir INN 400 mg and Velpatasvir INN 100 mg. Panovir Blister Pack which contains one blister strip with 6 tablets of Sofosbuvir and Velpatasvir. Sofosbuvir and Velpatasvir Container Pack which holds 28 tablets of Panovir.

Indications :

Panovir Tablet or Sofosbuvir and Velpatasvir combination is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6.
– Panovir is indicated without or with compensated cirrhosis.
– Panovir may also indicate with decompensated cirrhosis for usage in conjunction with ribavirin.

Therapeutic/Drug Class:

Hepatic viral infections (Hepatitis C).

Pharmacology:

Panovir contains Sofosbuvir which inhibits the HCV NS5B RNA-dependent RNA polymerase, which is necessary for virus replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to produce the pharmacologically active uridine analog triphosphate (GS-461203), which can be integrated into HCV RNA by the NS5B polymerase and function as a chain terminator. In a biochemical study, GS-461203 reduced the polymerase activity of recombinant NS5B from HCV genotypes 1b, 2a, 3a, and 4a, with IC50 values ranging from 0.36 to 3.3 micromolar. GS-461203 does not inhibit human DNA or RNA polymerases, nor does it affect mitochondrial RNA polymerase. Velpatasvir inhibits the HCV NS5A protein, which is necessary for viral replication. Velpatasvir’s method of action is indicated by resistance selection in cell culture and cross-resistance investigations, is NS5A targeting.

Cardiac Electrophysiology: An active-controlled (Moxifloxacin 400 mg) comprehensive QT study was conducted to assess the effect of Sofosbuvir 400 mg (recommended dosage) and 1200 mg (three times the recommended dosage) on the QTc interval. Sofosbuvir does not significantly extend QTc at three times the recommended dose. Velpatasvir 500 mg (five times the prescribed dosage) was studied in an active-controlled (Moxifloxacin 400 mg) comprehensive QT study. Velpatasvir does not significantly lengthen the QTc interval at five times the recommended dose.

Dosage and Administration of Panovir:

Testing prior to the start of therapy: Before starting HCV treatment with Panovir ( Sofosbuvir and Velpatasvir), all patients should be tested for current or past HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).Recommended Treatment of Panovir and Duration in Patients 3 Years of Age and Up: For individuals with HCV/HIV-1 coinfection & for liver transplant recipients without or with compensated cirrhosis (Child-Pugh A) is Sofobuvir and Velpatasvir once daily for 12 weeks, regardless of treatment experience.

Adults should take one tablet sofosbuvir  400 mg and 100 mg velpatasvir orally once day with or without food. When combined with Sofosbuvir and Velpatasvir, the suggested ribavirin dosage is weight-based (given with food): 1,000 mg per day for patients weighing less than 75 kg and 1,200 mg for those weighing more than 75 kg, divided and administered twice daily. The initial and on-treatment doses of ribavirin can be reduced based on hemoglobin and creatinine clearance. For ribavirin dosage adjustments, consult the ribavirin prescribing information. Patients with significant renal impairment or ESRD cannot be given a dosage advice of Sofosbuvir Velpatasvir 400 MG due to greater exposures to the major sofosbuvir metabolite.

Side Effects:
The most common side effects of the Panovir or Sofobuvir and Velpatasvir combination were fatigue, nausea, headache, anemia, diarrhea, sleeplessness, pruritus, muscular spasms, dyspnea, and cough. Some unusual adverse effects of Panovir include lower hemoglobin, lymphocyte, neutrophil, and platelet counts. Serious symptomatic bradycardia emerged when Sofosbuvir was combined with Amiodarone and another HCV Direct Acting Antiviral.

Drug Interaction:
Antacids, H2-receptor antagonists, proton pump inhibitors, and other drugs may lower Panovir or sofosbuvir and velpatasvir concentrations.Topotecan, Carbamazepine, Phenytoin, Phenobarbital, Oxcarbazepine, Rifabutin, Rifampin, Rifapentine, efavirenz, Tipranavir, Ritonavir, and Hypericum perforatum should not be taken together.

Use during pregnancy and lactation:
There are insufficient human data to determine whether the combination of Sofosbuvir and Velpatasvir or Panovir is risky for pregnancy outcomes. The combination of Sofosbuvir and Velpatasvir or Panovir with Ribavirin is not recommended for pregnant women or men whose female partner is pregnant or will become pregnant within the next six months.

Overdose:
There is no known antidote for overdose with Sofosbuvir and Velpatasvir. If an overdose occurs, the patient should be observed for signs of toxicity. Treatment for Panovir overdose comprises of general supportive measures such as monitoring vital signs and observing the patient’s clinical status. With an extraction ratio of 53%, hemodialysis can effectively remove Sofosbuvir’s major circulating metabolite, GS-331007. Velpatasvir is strongly attached to plasma protein, therefore hemodialysis is unlikely to remove it significantly.

Storage Conditions:
Panovir should be kept between 25°C and 30°C at room temperature. When a medication is no longer needed or has expired, dispose of it safely. Protect Panovir from sunlight and humidity. Keep Velpatasvir and all medicines out of the reach of children.

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