Sofosbuvir/Velpatasvir (sofosbuvir/velpatasvir)
Sofosbuvir/Velpatasvir is a direct-acting antiviral (daa) for hepatitis c; fixed-dose combination of an hcv ns5b nucleotide analogue polymerase inhibitor (sofosbuvir) and an hcv ns5a inhibitor (velpatasvir). atc j05ap55. from Gilead Sciences (Gilead Sciences Ireland UC for the EU), marketed originally as Epclusa. This monograph covers approved indications, mechanism, dosing, side effects and the manufacturer landscape.
Overview
Sofosbuvir/velpatasvir (Epclusa, 丙通沙) is a fixed-dose direct-acting antiviral (DAA) tablet for chronic hepatitis C. Each tablet contains sofosbuvir 400 mg, an HCV NS5B nucleotide analogue polymerase inhibitor, and velpatasvir 100 mg, an HCV NS5A inhibitor. It is the first pangenotypic regimen: a single 12-week course treats HCV genotypes 1, 2, 3, 4, 5 and 6 in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A). In adults with decompensated cirrhosis (Child-Pugh B or C) the tablet is given with weight-based ribavirin for 12 weeks. In the registration trials 98% of 1,035 adults with genotypes 1-6 and no decompensated cirrhosis had no detectable virus 12 weeks after finishing therapy (SVR12), and the dose is unchanged at any level of renal impairment, including haemodialysis. The drug is well tolerated; headache (18%), fatigue (15%), nausea (8%) and diarrhoea (6%) are the commonest reactions. The boxed warning concerns reactivation of hepatitis B in HCV/HBV coinfected patients, so all patients must be screened with HBsAg and anti-HBc before starting and monitored during and after treatment. Symptomatic bradycardia has been reported with concurrent amiodarone, and patients with decompensated cirrhosis who receive ribavirin need clinical and hepatic laboratory monitoring. 57-8.
How it works
Blocks two proteins the hepatitis C virus needs in order to copy itself: NS5B (blocked by sofosbuvir) and NS5A (blocked by velpatasvir). With the virus unable to multiply, the infection clears from the blood over the 12-week course.
Sofosbuvir is a nucleotide prodrug metabolised intracellularly to the active uridine triphosphate analogue GS-461203, which inhibits HCV NS5B RNA-dependent RNA polymerase (chain terminator). Velpatasvir is a direct-acting HCV NS5A inhibitor that blocks viral RNA replication and virion assembly.
Approved indications
- US (FDA): treatment of adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).
- US (FDA): treatment of adults with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection with decompensated cirrhosis (Child-Pugh B or C), in combination with ribavirin.
- EU (EMA): treatment of patients from 3 years of age with chronic hepatitis C caused by all HCV genotypes (pangenotypic); ribavirin is added in adults with decompensated liver disease and may be considered in compensated cirrhosis with genotype 3.
- In clinical trials in adults the regimen is 12 weeks; 98% of 1,035 adults (genotypes 1-6, without decompensated cirrhosis) had no detectable virus 12 weeks after finishing 12 weeks of Epclusa.
Dosage & administration
Adults: one fixed-dose tablet containing sofosbuvir 400 mg + velpatasvir 100 mg taken orally once daily, with or without food. Standard duration is 12 weeks for treatment-naive and treatment-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A); patients with decompensated cirrhosis (Child-Pugh B or C) receive Epclusa plus ribavirin for 12 weeks (ribavirin 1,000 mg/day if <75 kg, 1,200 mg/day if >=75 kg, divided twice daily). Children 3 years and older: weight-based tablets or oral pellets.
Dose adjustment
Renal: no dosage adjustment recommended for any degree of renal impairment, including ESRD requiring dialysis (a 12-week trial in 59 adults on dialysis reported SVR of 95%). Hepatic: no dosage adjustment for mild, moderate or severe hepatic impairment (Child-Pugh A, B or C). Ribavirin dose modification follows the ribavirin label (CrCl <=50 mL/min).
Side effects
Headache (18%) · Fatigue (15%) · Nausea (8%) · Diarrhoea (6%) · Asthenia (5%) · Insomnia, rash, anaemia (1mg list; anaemia mainly when ribavirin is added)
- Nausea (7%) was the most common reaction in adults with severe renal impairment on dialysis
- Serious symptomatic bradycardia when co-administered with amiodarone (warning, not a common reaction)
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV. Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Epclusa. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy; some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up.
Monitoring
- Test all patients for evidence of current or prior HBV infection (HBsAg, anti-HBc) before starting
- Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during treatment and in post-treatment follow-up
- HCV RNA 12 weeks after the end of treatment (SVR12) to confirm cure
- Clinical and hepatic laboratory monitoring, including direct bilirubin, in patients with decompensated cirrhosis receiving Epclusa plus ribavirin
- Cardiac monitoring if amiodarone must be used concurrently (patients discontinuing amiodarone shortly before Epclusa also need monitoring)
Generic and biosimilar landscape
Epclusa is an EMA centrally authorised product (EU marketing authorisation 6 July 2016) and the reference product for generic sofosbuvir/velpatasvir. No FDA 'first generic' sofosbuvir/velpatasvir ANDA was found in this research; the Indian and Bangladeshi 400 mg/100 mg products (Natco Velpanat, Cipla Hepcvel, Zydus Sovihep V, Beacon Fixvel/Sofosvel and others) are national-approval generics whose substitution rests on product-specific bioequivalence data that should be checked before recommending an interchange.
Who makes it
| Manufacturer | Country | Brand | Strength | Notes |
|---|---|---|---|---|
| Natco Pharma Ltd | India | Velpanat | 400 mg + 100 mg tablet | Listed on 1mg at about Rs 16,406 per pack; also sold in strips of 28 tablets |
| Cipla Ltd | India | Hepcvel | 400 mg + 100 mg tablet | Listed on 1mg at about Rs 16,406 per pack |
| Zydus Lifesciences | India | Sovihep V | 400 mg + 100 mg tablet (bottle of 28) | Rs 13,945. 31 on PharmEasy, Rs 18,046 on 1mg |
| Dr. Reddy's Laboratories | India | Resof Total | 400 mg + 100 mg tablet | Listed on 1mg at about Rs 19,851 per pack |
| Beacon Pharmaceuticals PLC | Bangladesh | Fixvel; Sofosvel | 400 mg + 100 mg tablet | Fixvel pack information Tk 1,000 (1 x 6 pack Tk 6,000) on medex. com. bd; Sofosvel is Beacon's other 400/100 brand (also listed on osudpotro. com and skpharma. com. bd) |
| Incepta Pharmaceuticals Ltd | Bangladesh | Panovir | 400 mg + 100 mg tablet | Unit the data Tk 1,000 (1 x 6: Tk 6,000) |
| Everest Pharmaceuticals Ltd | Bangladesh | Velpanex | 400 mg + 100 mg tablet | Unit the data Tk 1,000 (1 x 7: Tk 7,000) |
| ACI Limited | Bangladesh | Sovel | 400 mg + 100 mg tablet | Unit the data Tk 1,000 (1 x 7: Tk 7,000) |
| Jenphar Bangladesh Ltd | Bangladesh | Velpacee | 400 mg + 100 mg tablet | Lowest Bangladeshi pack information found: Tk 930 (1 x 7: Tk 6,510) |
| Drug International Ltd | Bangladesh | HopSo-VL | 400 mg + 100 mg tablet | Unit the data Tk 1,000 (4 x 7: Tk 28,000) |
| Healthcare Pharmaceuticals Ltd | Bangladesh | Velatas | 400 mg + 100 mg tablet | Unit the data Tk 1,000 (1 x 7: Tk 7,000) |
| UniMed UniHealth Pharmaceuticals Ltd | Bangladesh | Velsovir | 400 mg + 100 mg tablet | Unit the data Tk 1,000 (1 x 7: Tk 7,000) |
Availability in Southeast Asia
| Country | Status | Notes |
|---|---|---|
| Philippines | Registered / available | MIMS Philippines carries both the Epclusa (sofosbuvir + velpatasvir) full monograph and a separate sofosbuvir + velpatasvir generic monograph. |
| Thailand | Available | MIMS Thailand lists a sofosbuvir + velpatasvir generic monograph (ATC J05AP55). |
| Hong Kong (regional reference market) | Registered | MIMS Hong Kong carries full Epclusa indications and dosage monographs including the 12 to <18 years dosing. |
| Southeast Asia (wider region) | Generic supply reachable from licensed Indian/Bangladeshi manufacturers | Gilead granted voluntary licences to 11 India-based generic manufacturers to make and distribute sofosbuvir and sofosbuvir/velpatasvir in 101 developing countries; country-by-country registration in each SEA market was not verified in this research. |
Frequently asked questions
What is sofosbuvir/velpatasvir (Epclusa) used to treat?
Sofosbuvir/Velpatasvir is approved for: US (FDA): treatment of adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). ; US (FDA): treatment of adults with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection with decompensated cirrhosis (Child-Pugh B or C), in combination with ribavirin. ; EU (EMA): treatment of patients from 3 years of age with chronic hepatitis C caused by all HCV genotypes (pangenotypic); ribavirin is added in adults with decompensated liver disease and may be considered in compensated cirrhosis with genotype 3. ; In clinical trials in adults the regimen is 12 weeks; 98% of 1,035 adults (genotypes 1-6, without decompensated cirrhosis) had no detectable virus 12 weeks after finishing 12 weeks of Epclusa. . It is a sofosbuvir/velpatasvir (Direct-acting antiviral), originally marketed as Epclusa (丙通沙) by Gilead Sciences (Gilead Sciences Ireland UC for the EU).
Is Natco Velpanat or Beacon Fixvel the same as Epclusa?
Epclusa is an EMA centrally authorised product (EU marketing authorisation 6 July 2016) and the reference product for generic sofosbuvir/velpatasvir. No FDA 'first generic' sofosbuvir/velpatasvir ANDA was found in this research; the Indian and Bangladeshi 400 mg/100 mg products (Natco Velpanat, Cipla Hepcvel, Zydus Sovihep V, Beacon Fixvel/Sofosvel and others) are national-approval generics whose substitution rests on product-specific bioequivalence data that should be checked before recommending an interchange. Manufacturers supplying sofosbuvir/velpatasvir generic versions include ACI Limited, Beacon Pharmaceuticals PLC, Cipla Ltd, Dr. Reddy's Laboratories, Drug International Ltd, Everest Pharmaceuticals Ltd, Healthcare Pharmaceuticals Ltd, Incepta Pharmaceuticals Ltd. Brands registered in Bangladesh include Fixvel, HopSo-VL, Panovir, Sovel, Velatas, Velpacee.
Can Epclusa be taken if I have kidney disease or am on dialysis?
Sofosbuvir/Velpatasvir (Direct-acting antiviral (DAA) for hepatitis C; fixed-dose combination of an HCV NS5B nucleotide analogue polymerase inhibitor (sofosbuvir) and an HCV NS5A inhibitor (velpatasvir). ATC J05AP55. , originally Epclusa (丙通沙) by Gilead Sciences (Gilead Sciences Ireland UC for the EU)) Blocks two proteins the hepatitis C virus needs in order to copy itself: NS5B (blocked by sofosbuvir) and NS5A (blocked by velpatasvir). With the virus unable to multiply, the infection clears from the blood over the 12-week course. Adults: one fixed-dose tablet containing sofosbuvir 400 mg + velpatasvir 100 mg taken orally once daily, with or without food. Standard duration is 12 weeks for treatment-naive and treatment-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A); patients with decompensated cirrhosis (Child-Pugh B or C) receive Epclusa plus ribavirin for 12 weeks (ribavirin 1,000 mg/da
What is the Epclusa boxed warning about hepatitis B?
Sofosbuvir/Velpatasvir (Direct-acting antiviral (DAA) for hepatitis C; fixed-dose combination of an HCV NS5B nucleotide analogue polymerase inhibitor (sofosbuvir) and an HCV NS5A inhibitor (velpatasvir). ATC J05AP55. , originally Epclusa (丙通沙) by Gilead Sciences (Gilead Sciences Ireland UC for the EU)) Blocks two proteins the hepatitis C virus needs in order to copy itself: NS5B (blocked by sofosbuvir) and NS5A (blocked by velpatasvir). With the virus unable to multiply, the infection clears from the blood over the 12-week course. Adults: one fixed-dose tablet containing sofosbuvir 400 mg + velpatasvir 100 mg taken orally once daily, with or without food. Standard duration is 12 weeks for treatment-naive and treatment-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A); patients with decompensated cirrhosis (Child-Pugh B or C) receive Epclusa plus ribavirin for 12 weeks (ribavirin 1,000 mg/da
How many weeks do you take Epclusa for hepatitis C genotype 3?
Standard dosing for sofosbuvir/velpatasvir: Adults: one fixed-dose tablet containing sofosbuvir 400 mg + velpatasvir 100 mg taken orally once daily, with or without food. Standard duration is 12 weeks for treatment-naive and treatment-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A); patients with decompensated cirrhosis (Child-Pugh B or C) receive Epclusa plus ribavirin for 12 weeks (ribavirin 1,000 mg/day if <75 kg, 1,200 mg/day if >=75 kg, divided twice daily). Children 3 years and older: weight-based tablets or oral pellets. Dose adjustments: Renal: no dosage adjustment recommended for any degree of renal impairment, including ESRD requiring dialysis (a 12-week trial in 59 adults on dialysis reported SVR of 95%). Hepatic: no dosage adjustment for mild, moderate or severe hepatic impairment (Child-Pugh A, B or C). Ribavirin dose modification follows the ribavirin label (CrCl <=50 mL/min).
What is the cure rate (SVR12) of Epclusa?
Sofosbuvir/Velpatasvir (Direct-acting antiviral (DAA) for hepatitis C; fixed-dose combination of an HCV NS5B nucleotide analogue polymerase inhibitor (sofosbuvir) and an HCV NS5A inhibitor (velpatasvir). ATC J05AP55. , originally Epclusa (丙通沙) by Gilead Sciences (Gilead Sciences Ireland UC for the EU)) Blocks two proteins the hepatitis C virus needs in order to copy itself: NS5B (blocked by sofosbuvir) and NS5A (blocked by velpatasvir). With the virus unable to multiply, the infection clears from the blood over the 12-week course. Adults: one fixed-dose tablet containing sofosbuvir 400 mg + velpatasvir 100 mg taken orally once daily, with or without food. Standard duration is 12 weeks for treatment-naive and treatment-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A); patients with decompensated cirrhosis (Child-Pugh B or C) receive Epclusa plus ribavirin for 12 weeks (ribavirin 1,000 mg/da
Is it safe to take Epclusa with amiodarone?
Sofosbuvir/Velpatasvir (Direct-acting antiviral (DAA) for hepatitis C; fixed-dose combination of an HCV NS5B nucleotide analogue polymerase inhibitor (sofosbuvir) and an HCV NS5A inhibitor (velpatasvir). ATC J05AP55. , originally Epclusa (丙通沙) by Gilead Sciences (Gilead Sciences Ireland UC for the EU)) Blocks two proteins the hepatitis C virus needs in order to copy itself: NS5B (blocked by sofosbuvir) and NS5A (blocked by velpatasvir). With the virus unable to multiply, the infection clears from the blood over the 12-week course. Adults: one fixed-dose tablet containing sofosbuvir 400 mg + velpatasvir 100 mg taken orally once daily, with or without food. Standard duration is 12 weeks for treatment-naive and treatment-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A); patients with decompensated cirrhosis (Child-Pugh B or C) receive Epclusa plus ribavirin for 12 weeks (ribavirin 1,000 mg/da
Do I need ribavirin with Epclusa for decompensated cirrhosis?
Sofosbuvir/Velpatasvir (Direct-acting antiviral (DAA) for hepatitis C; fixed-dose combination of an HCV NS5B nucleotide analogue polymerase inhibitor (sofosbuvir) and an HCV NS5A inhibitor (velpatasvir). ATC J05AP55. , originally Epclusa (丙通沙) by Gilead Sciences (Gilead Sciences Ireland UC for the EU)) Blocks two proteins the hepatitis C virus needs in order to copy itself: NS5B (blocked by sofosbuvir) and NS5A (blocked by velpatasvir). With the virus unable to multiply, the infection clears from the blood over the 12-week course. Adults: one fixed-dose tablet containing sofosbuvir 400 mg + velpatasvir 100 mg taken orally once daily, with or without food. Standard duration is 12 weeks for treatment-naive and treatment-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A); patients with decompensated cirrhosis (Child-Pugh B or C) receive Epclusa plus ribavirin for 12 weeks (ribavirin 1,000 mg/da
Which Bangladeshi and Indian companies make generic Epclusa?
Epclusa is an EMA centrally authorised product (EU marketing authorisation 6 July 2016) and the reference product for generic sofosbuvir/velpatasvir. No FDA 'first generic' sofosbuvir/velpatasvir ANDA was found in this research; the Indian and Bangladeshi 400 mg/100 mg products (Natco Velpanat, Cipla Hepcvel, Zydus Sovihep V, Beacon Fixvel/Sofosvel and others) are national-approval generics whose substitution rests on product-specific bioequivalence data that should be checked before recommending an interchange. Manufacturers supplying sofosbuvir/velpatasvir generic versions include ACI Limited, Beacon Pharmaceuticals PLC, Cipla Ltd, Dr. Reddy's Laboratories, Drug International Ltd, Everest Pharmaceuticals Ltd, Healthcare Pharmaceuticals Ltd, Incepta Pharmaceuticals Ltd. Brands registered in Bangladesh include Fixvel, HopSo-VL, Panovir, Sovel, Velatas, Velpacee.
Sources
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f30631a-ee3b-4cfe-866b-964df3f0a44f
- https://www.ema.europa.eu/en/medicines/human/EPAR/epclusa
- https://medex.com.bd/generics/1006/sofosbuvir-velpatasvir/brand-names
- https://www.1mg.com/generics/sofosbuvir-velpatasvir-405072
- https://pharmeasy.in/molecules/sofosbuvir-velpatasvir-1086
- https://www.drugs.com/the data-guide/sofosbuvir-velpatasvir
- https://www.mims.com/philippines/drug/info/epclusa?type=full
- https://www.mims.com/thailand/drug/info/sofosbuvir-plus-velpatasvir?mtype=generic
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