Sofosbuvir (sofosbuvir)
Also sold as: Hepcinat, MyHep, Sofovir, Sovaldi
Pregnancy
Cat X
Lactation
Avoid
Schedule
H1
Forms
Tablet 400mg +2
Indications
- Chronic Hepatitis C (HCV) genotype 1 — in combination with ledipasvir or simeprevir
- Chronic Hepatitis C (HCV) genotype 2 — in combination with ribavirin
- Chronic Hepatitis C (HCV) genotype 3 — in combination with daclatasvir
- Chronic Hepatitis C (HCV) genotype 4, 5, 6 — in combination with ledipasvir or velpatasvir
- HCV with compensated cirrhosis
- HCV in HIV co-infected patients (part of regimen)
- HCV in liver transplant recipients
Adult Dosing
HCV Genotype 1 — with ledipasvir (sofosbuvir/ledipasvir FDC)
Sofosbuvir 400mg + ledipasvir 90mg once daily
12 weeks (treatment-naive without cirrhosis); 24 weeks (treatment-experienced or with cirrhosis)
Take with or without food. Sofosbuvir/ledipasvir (Harvoni equivalent) is preferred for Genotype 1 in India — generic Hepcinat-LP available at dramatically lower cost.
HCV Genotype 2 — with ribavirin
Sofosbuvir 400mg once daily + ribavirin (weight-based: 1000mg/day if <75kg or 1200mg/day if ≥75kg)
12 weeks
Ribavirin causes haemolytic anaemia — monitor Hb closely; dose reduction often required
HCV Genotype 3 — with daclatasvir
Sofosbuvir 400mg + daclatasvir 60mg once daily
12 weeks (no cirrhosis); 24 weeks (with cirrhosis) — consider adding ribavirin for cirrhotic patients
Genotype 3 has lower SVR rates than other genotypes; cirrhotic patients particularly challenging — specialist management recommended
HCV all genotypes — with velpatasvir (sofosbuvir/velpatasvir FDC — pangenotypic)
Sofosbuvir 400mg + velpatasvir 100mg once daily
12 weeks for all genotypes (treatment-naive and -experienced without cirrhosis)
Pangenotypic — can be used when genotype unknown. Simpler approach for settings with limited genotyping. Add ribavirin for decompensated cirrhosis (with specialist guidance).
HCV with decompensated cirrhosis (specialist only)
Sofosbuvir 400mg + velpatasvir 100mg + ribavirin (weight-based) once daily
12 weeks
Manage only under specialist care (hepatologist). Close monitoring of liver function, coagulation, and renal function. Avoid in Child-Pugh C without transplant planning.
Pediatric Dosing
Pediatric use requires specialist hepatology guidance. Fixed-dose combination tablets not appropriate for small children. Sofosbuvir is not routinely used for HCV in children <12 years without specialist input in India.
Hepatic Adjustment
Sofosbuvir is safe in compensated cirrhosis (Child-Pugh A) — standard dose, no adjustment required. Child-Pugh B (moderate decompensation): use with extreme caution under specialist supervision, with ribavirin added. Child-Pugh C (severe decompensation): contraindicated without specialist guidance and liver transplant planning — risk of fatal hepatic decompensation.
Pregnancy & Lactation
Pregnancy: Category X
Sofosbuvir itself is not clearly teratogenic (animal data reassuring, limited human data). However, sofosbuvir is almost universally used with ribavirin, which is a known teratogen (Category X) and has a 6-month contraception requirement after stopping. Contraindicated during pregnancy due to ribavirin co-administration. Adequate contraception required for both female patients AND female partners of male patients during ribavirin-containing regimens and for 6 months after.
Lactation: Avoid
Sofosbuvir is excreted in animal breast milk; no human data available. Due to uncertainty and the potential severity of HCV (treatment can be deferred post-breastfeeding in stable disease), breastfeeding is generally not recommended during sofosbuvir therapy. Defer treatment until breastfeeding is complete if clinically feasible.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| Rifampicin / Rifabutin | Contraindicated — rifampicin is a potent P-glycoprotein (P-gp) and CYP inducer that reduces sofosbuvir AUC by ~72%; renders sofosbuvir ineffective | Major |
| Carbamazepine / Phenytoin / Phenobarbitone | Contraindicated — potent P-gp inducers; major reduction in sofosbuvir exposure; co-administration is absolutely contraindicated | Major |
| Amiodarone | Contraindicated — serious and potentially fatal symptomatic bradycardia reported when amiodarone is co-administered with sofosbuvir in combination with NS5A inhibitors (ledipasvir, daclatasvir, velpatasvir); cases of cardiac arrest and pacemaker insertion reported | Major |
| St John's Wort (Hypericum perforatum) | Contraindicated — potent P-gp and CYP3A4 inducer; expected to significantly reduce sofosbuvir concentrations; do not co-administer | Major |
| Tenofovir (with ledipasvir-sofosbuvir combination) | Ledipasvir (when co-formulated with sofosbuvir) increases tenofovir disoproxil levels ~98%; increased risk of TDF nephrotoxicity; only co-administer with boosted (ritonavir/cobicistat) ART regimens; monitor renal function closely or switch to TAF-based regimen | Major |
| Tipranavir/ritonavir | Reduces sofosbuvir AUC by ~76%; avoid co-administration | Major |
| Antacids (aluminium/magnesium) or omeprazole (with ledipasvir component) | Ledipasvir requires gastric acid for solubility; antacids/PPIs reduce ledipasvir absorption. Separate antacid administration by 4 hours; avoid omeprazole >20mg/day with sofosbuvir/ledipasvir. | Moderate |
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Side Effects
Common
- Fatigue (very common — up to 40% with ribavirin-containing regimens)
- Headache
- Nausea
- Insomnia
- Anaemia (ribavirin-related haemolytic anaemia — common)
- Rash (ribavirin-related)
- Pruritus
- Irritability or mood changes (ribavirin)
- Diarrhoea
- Decreased appetite
Serious / Discontinue If
- Symptomatic bradycardia (potentially fatal) — with amiodarone co-administration; cardiac monitoring required for 48h if combination unavoidable
- Severe anaemia (haemolytic) from ribavirin component — transfusion may be required; dose reduction or discontinuation needed if Hb <10g/dL
- Hepatic decompensation in advanced cirrhosis
- HCV reactivation during or after direct-acting antiviral therapy — rare
- HBV reactivation in HBsAg-positive or anti-HBc-positive patients — test for HBV before starting HCV treatment; risk of fulminant hepatitis
Contraindications
- Concomitant use with rifampicin, rifabutin
- Concomitant use with carbamazepine, phenytoin, phenobarbitone
- Concomitant use with amiodarone (with NS5A inhibitor-containing regimens)
- Concomitant use with St John's Wort
- Pregnancy (due to ribavirin teratogenicity in ribavirin-containing regimens)
- Decompensated cirrhosis (Child-Pugh C) — relative contraindication; specialist-only decision
- Severe renal impairment (CrCl <30mL/min) — sofosbuvir metabolite accumulates; no dose recommendation established
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Hepcinat 400mg (sofosbuvir) | Natco Pharma | ₹1,000 for 28 tablets |
| MyHep 400mg (sofosbuvir) | Mylan (Viatris India) | ₹1,200 for 28 tablets |
| Sofovir 400mg (sofosbuvir) | Hetero Healthcare | ₹950 for 28 tablets |
Monitoring Required
- HCV RNA (viral load) — at baseline, week 4 (rapid virological response), week 12 end of treatment, and 12 weeks post-treatment (SVR12 — confirmed cure)
- HCV genotype and viral load — before starting treatment to guide regimen selection and duration
- Liver function tests (ALT, AST, bilirubin, albumin, INR) — at baseline, week 4, and end of treatment
- Renal function — serum creatinine and eGFR at baseline and during treatment, especially if on TDF or other nephrotoxins
- Full blood count — haemoglobin monthly if on ribavirin (haemolytic anaemia)
- HBsAg and anti-HBc before starting HCV treatment — HBV reactivation risk; start HBV treatment if HBsAg positive
- Pregnancy test before initiating ribavirin-containing regimen; monthly pregnancy tests during therapy and for 6 months after
- Amiodarone use — cardiac monitoring for 48 hours if combination unavoidable (ideally avoid entirely)
- Drug interactions — review all medications before starting, particularly anticonvulsants and antitubercular drugs
- Fibrosis staging — FibroScan or APRI score to assess for cirrhosis and guide treatment duration
Patient Counseling Points
- Take sofosbuvir once daily with or without food — consistency is key; take at the same time each day
- This treatment can cure hepatitis C — completing the full course as prescribed gives you the best chance of cure (SVR)
- Do not miss doses — even one missed dose can reduce cure rates; set a daily alarm
- NEVER stop treatment early without consulting your doctor — completing the course is essential
- Inform your doctor about ALL medications, supplements, and herbal products — especially St John's Wort, antiepileptic drugs, or tuberculosis treatment
- If you are on amiodarone (heart medication), inform your hepatitis doctor before starting this treatment — serious heart rhythm problems can occur
- If ribavirin is part of your regimen: women must use two reliable methods of contraception; male patients whose female partners could become pregnant must also use contraception. Continue contraception for 6 months after treatment ends.
- Report any unusual fatigue, shortness of breath, or pallor (signs of anaemia from ribavirin)
- You will need a blood test 12 weeks after completing treatment to confirm the virus has been eliminated (SVR12)
- After cure, you can still be reinfected with hepatitis C — avoid sharing needles, syringes, or unsterilised instruments
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Clinically reviewed by: Dr. Priya Ramachandran, MD (Medicine), DNB (Infectious Diseases), AIIMS New Delhi
Last reviewed: 2026-04-01
References
- EASL Recommendations on Treatment of Hepatitis C: Final Update of the Series (2020)
- WHO Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection (2018)
- Gilead Sciences Sovaldi (sofosbuvir) US Prescribing Information
- AASLD-IDSA HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C (2023)
- UpToDate: Treatment regimens for chronic hepatitis C virus genotype 1, 2, 3, 4, 5, 6 infection (2025)
- Micromedex Solutions — Sofosbuvir monograph
- National Centre for Disease Control (NCDC) India — Hepatitis C treatment guidelines (2023)