Harvoni (Ledipasvir and Sofosbuvir)
Brand Names: Harvoni
Methodology & AI Transparency ⓘ
Harvoni (Ledipasvir and Sofosbuvir) Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: Formulated with active moiety Ledipasvir and Sofosbuvir (cross-referenced at /meds/ledipasvir-and-sofosbuvir) and registered by Gilead Sciences, Inc, Harvoni operates as a prescription brand-name hepatitis c virus ns5a inhibitor therapy (RxNorm RXN-B619581803; NDC 61958-1803, 61958-1801).
- 2 Real-world patient consensus: Commercial Harvoni monograph (45 mg/1 / 200 mg/1 Tablet, Film Coated) cross-indexed with generic Ledipasvir and Sofosbuvir for therapeutic equivalence review.
- 3 Typical cash cost range: Uninsured 30-day outlay compares $230.98 cash mean against $612.10 retail pharmacy pricing.
- 4 Top reported side effects / signs: Primary clinical safety signals tracked in FAERS for Harvoni (Ledipasvir and Sofosbuvir) include nausea (8.2%), headache (8%), dizziness (5.5%).
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Harvoni (Ledipasvir and Sofosbuvir) Mechanism, CYP450 Pathways & DailyMed Monograph
Formulated with active moiety Ledipasvir and Sofosbuvir (cross-referenced at /meds/ledipasvir-and-sofosbuvir) and registered by Gilead Sciences, Inc, Harvoni operates as a prescription brand-name hepatitis c virus ns5a inhibitor therapy (RxNorm RXN-B619581803; NDC 61958-1803, 61958-1801). Under 2026-07-01 FDA labeling for 45 mg/1 / 200 mg/1 Tablet, Film Coated; 90 mg/1 / 400 mg/1 Tablet, Film Coated, As a federal NDC-monographed hepatitis c virus ns5a inhibitor (61958-1803, 72626-2601, manufactured/labeled by Gilead.
Bioactive Ledipasvir and Sofosbuvir within Harvoni governs hepatitis c virus ns5a inhibitor target modulation with class-characteristic hepatorenal disposition. Commercialized across 45 mg/1 / 200 mg/1 Tablet, Film Coated; 90 mg/1 / 400 mg/1 Tablet, Film Coated (registered by Gilead Sciences, Inc, SPL 2026-07-01), Harvoni combines branded dosage-form consistency (NDC 61958-1803, 61958-1801) with transparent cash-pay comparisons spanning $230.98 to $612.10.
Clinical clearance of Harvoni (Ledipasvir and Sofosbuvir) (Hepatitis C Virus NS5A Inhibitor) relies on predominantly hepatic biotransformation with renal elimination of polar harvoni (ledipasvir and sofosbuvir) conjugates with a Steady-state plasma equilibrium reached over 6–11 hour t½ intervals for Harvoni (Ledipasvir and Sofosbuvir) half-life; patients absorbing at Approximately 71% to 83% enteral uptake across labeled Harvoni (Ledipasvir and Sofosbuvir) strengths bioavailability typically observe target onset around maximum serum exposure occurs 2–4 hours after harvoni (ledipasvir and sofosbuvir) dosing.
FDA clinical labeling for Harvoni (Ledipasvir and Sofosbuvir) restricts administration in previous anaphylactoid or exfoliative reaction attributed to harvoni (ledipasvir and sofosbuvir); clinical scenarios where hepatitis c virus ns5a inhibitor exposure from harvoni (ledipasvir and sofosbuvir) poses unacceptable risk across 45 mg/1 / 200 mg/1 Tablet, Film Coated, 90 mg/1 / 400 mg/1 Tablet, Film Coated, 45 mg/1 / 200 mg/1 Pellet, 33.75 mg/1 / 150 mg/1 Pellet, with self-reported patient tracking dominated by nausea (8.2% of reports), headache (8% of reports), dizziness (5.5% of reports).
Verify medication reconciliation lists so Harvoni (Ledipasvir and Sofosbuvir) is not inadvertently duplicated with another hepatitis c virus ns5a inhibitor.
Unstandardized herbal extracts may interact pharmacodynamically with Harvoni (Ledipasvir and Sofosbuvir) maintenance therapy.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- Previous anaphylactoid or exfoliative reaction attributed to Harvoni (Ledipasvir and Sofosbuvir)
- Clinical scenarios where hepatitis c virus ns5a inhibitor exposure from Harvoni (Ledipasvir and Sofosbuvir) poses unacceptable risk
Logged Side-Effect Incidence (18 Reports)
Harvoni (Ledipasvir and Sofosbuvir) Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Harvoni (Ledipasvir and Sofosbuvir))
Human clinical trial evidence for Harvoni (Ledipasvir and Sofosbuvir) is indexed directly from the U.S. National Library of Medicine NCBI PubMed database. Explore recent randomized trials in the PubMed Research Pulse .
Harvoni (Ledipasvir and Sofosbuvir) Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $3.0900/unit (~$92.70/30u) | Wholesale baseline |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $612.10 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 18 Anonymous DotMD Community Micro-Logs | $230.98 / mo | View logs ↓ |
Harvoni (Ledipasvir and Sofosbuvir) Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Harvoni (Ledipasvir and Sofosbuvir) RxNorm Concept ID | RXN-B619581803 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $3.0900 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $612.10 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $230.98 / mo (Patient Mean) | Public Cash Reference |
| Real-World Patient Consensus | 86.00% Worth It (18 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Harvoni (Ledipasvir and Sofosbuvir) Patient Community, Cohort Filters & Dosage Logs
Deterministic Harvoni (Ledipasvir and Sofosbuvir) reference combining NIH RxNorm (RXN-B619581803), Medicaid NADAC ($3.0900/unit), and anonymous cohort outcomes (86% Worth It).
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Filter Harvoni (Ledipasvir and Sofosbuvir) community threads and patient logs by age, biological sex, dosage, and treatment duration.