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Harvoni

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Harvoni (Ledipasvir, Sofosbuvir) is a breakthrough combination antiviral medication used to treat chronic Hepatitis C. It works by directly inhibiting the enzymes the virus needs to replicate within the body. This treatment is effective across several genotypes and aims to clear the virus from the bloodstream entirely.


Category
Availability
In Stock
Delivery Time
Airmail (14-21 days) | EMS trackable (5-9 days)
Product is shipped in a fully discreet envelope with no content disclosure, including all required documentation inside

Product Sheet

Active Ingredient(s)
Ledipasvir, Sofosbuvir
Reference Brand
Harvoni
Manufacturer
Gilead Sciences
Product Form
Film-coated tablet
Regulatory Classification
Rx
Primary Category
Antiviral Medication
Product Category
Antivirals for systemic use, Direct-acting antivirals, Hepatitis C treatment
Pharmacological Class
NS5A inhibitor, Nucleotide analogue NS5B polymerase inhibitor
Clinical Indications
Manufacturer Description
A combined antiviral treatment used to cure chronic Hepatitis C in adults and children.
Mechanism of Action
This medication combines two direct-acting antivirals that interfere with the proteins required by the Hepatitis C virus to replicate. By blocking these proteins, it reduces the viral load in the body to undetectable levels, effectively curing the infection in most patients.
Route of Administration
Oral
Onset Time
Within 1 to 2 hours (absorption)
Duration
24 hours
Contraindications
Hypersensitivity to active substances, Coadministration with Rosuvastatin, Coadministration with St John's Wort
Severe Adverse Events
Severe allergic reactions, Hepatitis B reactivation, Slow heart rate when taken with amiodarone
Common Side Effects
Headache, Fatigue, Nausea
Uncommon Side Effects
Insomnia, Diarrhoea, Dizziness
Drug Interactions
Amiodarone, Rifampicin, St John's Wort, Anticonvulsants
Pregnancy Safety Warnings
Consult a doctor; generally not recommended unless benefits outweigh risks.
Age Restrictions
Children aged 3 years and older and adults
Storage Guidelines
Store in the original package at room temperature (below 30°C).
Related Products
Epclusa, Vosevi, Zepatier

Harvoni FAQ

1. Can I travel internationally while taking Harvoni?

Yes, Harvoni tablets are not considered a controlled substance in the UK, but you should carry a copy of your prescription and a letter from your clinician if you are traveling to countries with strict medication import rules.

2. Does Harvoni interact with herbal supplements such as St. John’s wort?

St. John’s wort induces enzymes that can lower Harvoni concentrations, potentially reducing effectiveness. It is advisable to avoid this supplement during treatment or discuss alternatives with your pharmacist.

3. How does Harvoni compare with other HCV regimens like Epclusa?

Both Harvoni (ledipasvir/sofosbuvir) and Epclusa (sofosbuvir/velpatasvir) contain sofosbuvir, but they differ in the second component. Epclusa is approved for all HCV genotypes, whereas Harvoni is primarily used for genotypes 1, 4, 5, and 6. Choice depends on genotype, prior treatment history, and specialist recommendation.

4. What should I do if I miss a dose while on a weekend?

Take the missed tablet as soon as you remember, provided it is the same day. If you realise the omission the next day, skip the missed dose and continue with the regular schedule; do not double-dose.

5. Is Harvoni safe for people with mild renal impairment?

Patients with eGFR ≥ 30 mL/min/1.73 m² can use Harvoni without dose adjustment. Those with more severe renal dysfunction require specialist assessment before starting therapy.

6. Can Harvoni be taken with antacids?

Antacids containing aluminium or magnesium may reduce absorption if taken within two hours of the Harvoni tablet. Separate administration by at least two hours is recommended.

7. Why is a post-treatment HCV RNA test (SVR12) necessary?

SVR12 confirms that the virus has been eradicated. A negative result at 12 weeks after therapy is considered a cure and guides long-term follow-up planning.

8. Are there any dietary restrictions while on Harvoni?

There are no specific dietary restrictions. However, maintaining a balanced diet supports liver health during treatment.

9. How long does a Harvoni tablet stay effective after the expiry date?

Do not use Harvoni beyond the printed expiry date. Potency cannot be guaranteed after this point, and the medication should be disposed of safely.

10. Does Harvoni affect laboratory tests for drug screening?

Harvoni is not known to cause false-positive results in standard drug-of-abuse screens, but athletes subject to anti-doping testing should disclose all prescribed medications to the relevant authority.

Harvoni: Antiviral Medication Overview

Harvoni combines the active ingredients ledipasvir and sofosbuvir in a single oral tablet (90 mg / 400 mg). It belongs to the antiviral class of medicines and is approved in the United Kingdom for the treatment of chronic hepatitis C virus (HCV) infection. The medication is supplied as a film-coated pill and is prescribed only by a qualified healthcare professional.

Regulatory status: Prescription-only medicine (POM) authorized by the Medicines and Healthcare products Regulatory Agency (MHRA).

Manufacturer: Gilead Sciences Ltd. (UK subsidiary).

How Harvoni Works in the Body

Harvoni’s antiviral effect stems from the complementary actions of its two components:

  • Ledipasvir is an inhibitor of the HCV non-structural protein 5A (NS5A). NS5A is essential for viral replication and assembly; blocking it prevents the virus from producing new particles.
  • Sofosbuvir is a nucleotide analogue that targets the HCV non-structural protein 5B (NS5B) RNA-dependent RNA polymerase. By mimicking the natural building blocks of viral RNA, sofosbuvir terminates the RNA chain and halts replication.

Together, the drugs achieve a rapid decline in circulating HCV RNA, typically within the first two weeks of therapy. The combination provides a high barrier to resistance and allows a once-daily dosing schedule.

Approved Medical Uses

Harvoni is approved in the UK for the following HCV-related indications:

  • Genotype 1 (subtypes 1a and 1b) infection, with or without compensated cirrhosis, when treated for 8 weeks (treatment-naïve, low viral load) or 12 weeks (all other scenarios).
  • Genotype 4, 5, and 6 infections, irrespective of cirrhosis status, for a 12-week course.

These approvals are based on clinical trials demonstrating sustained virologic response at 12 weeks after treatment (SVR12) rates of >95 % in most patient groups. The medication is indicated for adults (≥ 18 years) and is not recommended for use in children unless specifically authorised in a clinical trial.

Off-Label and Investigational Applications

Evidence from small studies suggests possible benefit of ledipasvir/sofosbuvir in:

  • Genotype 3 infection in patients who cannot tolerate ribavirin. Current guidelines consider this an off-label use; efficacy appears lower than with genotype-specific regimens.
  • Post-transplant HCV recurrence, where early antiviral therapy may protect graft function.

Disclaimer: These uses are not approved by the MHRA. Off-label prescribing must be performed under specialist supervision, with individual risk assessment.

Patient Suitability and Contraindications

Ideal candidates are adults with chronic HCV genotype 1, 4, 5, or 6 infection, who have adequate renal function (eGFR ≥ 30 mL/min/1.73 m²) and no contraindicated concomitant medications.

Absolute Contraindications

  • Known hypersensitivity to ledipasvir, sofosbuvir, or any excipients in the tablet.
  • Co-administration with amiodarone (due to risk of severe bradycardia).

Relative Contraindications

  • Severe renal impairment (eGFR < 30 mL/min/1.73 m²). Use only under specialist advice.
  • Decompensated cirrhosis (Child-Pugh B or C) - safety data are limited.
  • Pregnancy or breastfeeding - limited data; therapy should be deferred until after delivery when possible.

Special Populations

  • Women of child-bearing potential should use reliable contraception during treatment and for at least 6 weeks after the last dose.
  • Elderly patients generally tolerate Harvoni well, but renal function should be assessed before initiation.

Safety Profile: Side Effects and Interactions

Common Side Effects

  • Fatigue (≈ 30 %)
  • Headache (≈ 20 %)
  • Nausea (≈ 15 %)
  • Insomnia (≈ 10 %)

These events are usually mild and transient, often improving without intervention.

Serious Adverse Events

  • Bradycardia when used together with amiodarone or other strong AV-node blockers.
  • Hepatic decompensation in patients with previously compensated cirrhosis who progress during therapy.
  • Rash or allergic reactions requiring discontinuation.

Drug Interactions

| Interaction Type | Representative Drugs | Clinical Significance | ||-|--| | Major | Amiodarone, dronedarone | May cause serious bradycardia; avoid co-administration. | | Moderate | Rifampin, carbamazepine, phenytoin, St. John’s wort | Induce enzymes that reduce Harvoni exposure; dose adjustment or alternative therapy required. | | Moderate | HIV protease inhibitors boosted with ritonavir, atazanavir, lopinavir/ritonavir | May increase ledipasvir concentrations; monitor for toxicity. | | Minor | Antacids containing aluminium or magnesium | May reduce absorption if taken within 2 hours of the tablet; separate administration recommended. |

Food and Lifestyle Interactions

  • Harvoni can be taken with or without food; a high-fat meal does not affect exposure.
  • No known interaction with alcohol, but patients with advanced liver disease should limit intake.
  • No impairment of driving or machine operation reported.

If a patient is taking other medicines, a pharmacist should review the full list for potential interactions.

How to Take Harvoni

  • Standard dosing: One tablet (90 mg / 400 mg) taken orally once daily, preferably at the same time each day.
  • Treatment duration: 8 weeks for selected genotype 1-naïve patients with low baseline viral load; otherwise 12 weeks.
  • Renal adjustment: No dose reduction is required for eGFR ≥ 30 mL/min/1.73 m². In severe renal impairment, specialist guidance is mandatory.
  • Administration: Swallow the tablet whole with a glass of water. Crushing or chewing is not recommended.
  • Missed dose: Take the forgotten tablet as soon as remembered on the same day; do not double the next dose.
  • Overdose: No specific antidote; provide supportive care and monitor hepatic and renal function.
  • Discontinuation: Abrupt cessation is generally safe, but completion of the prescribed course maximises cure rates.

Monitoring and Follow-Up

  • Baseline: HCV RNA viral load, genotype, liver function tests (ALT, AST, bilirubin), renal function (eGFR), and assessment for cirrhosis (ultrasound or elastography).
  • During therapy: HCV RNA at week 4 (optional) and at end of treatment to confirm viral suppression.
  • Post-treatment: HCV RNA at week 12 after the last dose (SVR12) to verify cure.
  • Safety labs: Repeat liver enzymes and renal function at week 4 and at end of therapy, especially in patients with pre-existing liver disease or reduced eGFR.

Storage and Handling

  • Store tablets at controlled room temperature (15-30 °C) in the original blister pack, protected from moisture and light.
  • Do not refrigerate or freeze.
  • Keep out of reach of children.
  • Dispose of unused tablets according to local pharmacy take-back programmes or NHS guidelines for medicines waste.

Medication-Specific Glossary

Sustained Virologic Response (SVR12)
The absence of detectable HCV RNA 12 weeks after completing therapy, regarded as a virological cure.
NS5A Inhibitor
A drug class that blocks the HCV non-structural protein 5A, impairing viral replication and assembly. Ledipasvir belongs to this class.
NS5B Polymerase
The viral RNA-dependent RNA polymerase responsible for copying the HCV genome; sofosbuvir acts as a chain-terminating nucleotide analogue.
eGFR (estimated Glomerular Filtration Rate)
A calculation of kidney filtration capacity, used to assess renal function for dosing decisions.
Child-Pugh Score
A clinical scoring system (A-C) that evaluates the severity of liver cirrhosis and guides treatment choices.

Medical Disclaimer

This article provides educational information about Harvoni and is not a substitute for professional medical advice. Treatment decisions, including the use of unapproved indications, must be made under the guidance of a qualified healthcare provider. The content is intended for informational purposes only and does not constitute medical recommendations. Always consult a physician before starting, stopping, or changing any medication regimen.

Information for Harvoni is sourced from established medical standards and updated frequently. It is provided for general guidance and should be confirmed with a healthcare professional before use.
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