What is Ledipasvir/Sofosbuvir? Understanding the Active Ingredients
Harvoni is a fixed-dose combination of two direct-acting antivirals (DAAs): Ledipasvir (90mg), an NS5A inhibitor, and Sofosbuvir (400mg), a nucleotide analogue NS5B polymerase inhibitor. Together, they target two essential proteins in the HCV replication cycle, creating a powerful synergistic antiviral effect.
Approved by the FDA in October 2014, Harvoni was the first single-tablet, all-oral regimen for Hepatitis C — eliminating the need for interferon injections and their severe side effects. This revolutionized HCV treatment, turning a chronic disease requiring 48 weeks of difficult therapy into a simple 8-12 week oral cure.
With over 1.5 million patients treated worldwide, Harvoni has one of the most extensive real-world safety and efficacy databases of any antiviral. Cure rates (SVR12) consistently exceed 94-99% across all studied populations, including patients with compensated cirrhosis, HIV co-infection, and prior treatment failure.
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Harvoni vs Other Hepatitis C Treatments — 2026 Comparison
| Feature | Harvoni (Ledipasvir/Sofosbuvir) | Epclusa (Sofosbuvir/Velpatasvir) | Mavyret (Glecaprevir/Pibrentasvir) |
|---|---|---|---|
| Genotype Coverage | GT 1, 4, 5, 6 | Pan-genotypic (GT 1-6) | Pan-genotypic (GT 1-6) |
| SVR12 Rate (GT1) | 94-99% | 98-99% | 97-99% |
| Treatment Duration | 8-12 weeks | 12 weeks | 8-16 weeks |
| Dosing | Once daily, 1 tablet | Once daily, 1 tablet | Once daily, 3 tablets |
| Interferon-Free | ✅ Yes | ✅ Yes | ✅ Yes |
| Ribavirin-Free | ✅ Most patients | ✅ Most patients | ✅ Yes |
| Cirrhosis Patients | ✅ Compensated | ✅ Compensated + Decompensated | ✅ Compensated only |
| US 12-Week Cost | $94,500 | $74,760 | $26,400 |
| Our Price | 70-80% savings | Available | Available |
Clinical Evidence — ION Landmark Trials
ION-1
99% SVR12 (12 weeks)
Treatment-naïve GT1, N=865, including 16% with cirrhosis
ION-2
94-99% SVR12 (12 weeks)
Treatment-experienced GT1, N=440, prior pegIFN/RBV failure
ION-3
94% SVR12 (8 weeks)
Treatment-naïve GT1 without cirrhosis, N=647 — shortest effective course
Harvoni Dosing & Treatment Guide
Standard Dose
One tablet (Ledipasvir 90mg / Sofosbuvir 400mg) taken orally once daily, with or without food
Treatment-Naïve Without Cirrhosis
8 weeks (if HCV RNA <6 million IU/mL) or 12 weeks. ION-3 demonstrated 94% SVR12 with 8-week course.
Treatment-Naïve With Cirrhosis
12 weeks without Ribavirin. Adding Ribavirin does not significantly improve outcomes in compensated cirrhosis.
Treatment-Experienced
12 weeks (without cirrhosis) or 24 weeks / 12 weeks + Ribavirin (with compensated cirrhosis). Consult hepatologist for optimal regimen.
Storage
Store below 30°C (86°F). Keep in original blister packaging. Protect from moisture. Shelf life: 36 months from manufacture.
Frequently Asked Questions About Harvoni (Ledipasvir/Sofosbuvir)
Find answers to common questions about ordering, pricing, and shipping.