Panovir (Sofosbuvir+Velpatasvir) treats specific genotypes of hepatitis C, and only in certain people. Sofosbuvir and velpatasvir sometimes use in people who also have HIV. This medicine is not a treatment for HIV or AIDS.

It is a fixed-dose combination tablet containing sofosbuvir and velpatasvir for oral administration. Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor and velpatasvir is an NS5A inhibitor.

Indications

Panovir combination indicate for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis and

with decompensated cirrhosis for use in combination with ribavirin

Dosage & Administration

The recommended dosage is one tablet of Panovir (400 mg of Sofosbuvir and 100 mg of Velpatasvir) taken orally once daily. Recommended treatment regimen:

• Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A) – one tablet once daily for 12 weeks
• Patients with decompensated cirrhosis (Child-Pugh B or C) – one tablet once daily and Ribavirin for 12 weeks. The recommended dosage of Ribavirin is based on bodyweight (1000 mg/day for patients < 75 kg and 1200 mg/day for ≥ 75 kg, in two divided dose/day)

No dosage recommendation can give for patients with severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2) or with ESRD, due to higher exposures of the predominant sofosbuvir metabolite.

Side Effects

The most common side effects of Panovir combination include headache and tiredness. Treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (a medicine used to treat certain heart problems).

Precautions

Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Co-administration of amiodarone with Sofosbuvir and Velpatasvir combination not recommend. In patients without alternative viable treatment options, cardiac monitoring is recommended.

Use in Pregnancy & Lactation

No adequate human data are available to establish whether or not Sofosbuvir and Velpatasvir combination poses a risk to pregnancy outcomes. If Sofosbuvir and Velpatasvir combination administered with Ribavirin, the combination regimen contraindicated in pregnant women and in men whose female partner is pregnant or going to be pregnant in next six months.

Drug Interaction

Drugs may decrease the concentrations of Panovir : Antacids, H2-receptor antagonists, Proton-pump inhibitors etc.

Coadministration is not recommended with: topotecan, Carbamazepine, Phenytoin, Phenobarbital, Oxcarbazepine, Rifabutin, Rifampin, Rifapentine, efavirenz, Tipranavir, Ritonavir, Hypericum perforatum.

Coadministration of Sofosbuvir and Velpatasvir combination, with Rosuvastatin, Atorvastatin may significantly increase the concentration of Rosuvastatin, Atorvastatin.

Overdose Effect

If overdose occurs the patient must monitor for evidence of toxicity. Treatment of overdose includes monitoring of vital signs as well as observation of the clinical status of the patient.

Storage

Store in a cool and dry place (preferably below 30°C). Keep out of reach of children.