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According to the European Medicines Agency, brand name Harvoni originating from Europe is manufactured at the following site(s):
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland
Information about Harvoni
Harvoni is a combination antiviral medication containing sofosbuvir and ledipasvir, used for the treatment of chronic hepatitis C virus (HCV) infection. It works by directly inhibiting the replication of the virus, leading to a sustained virologic response.
Product Highlights
- Indicated for the treatment of chronic hepatitis C in adults and certain pediatric populations, including those with specific genotypes (1, 4, 5, and 6).
Key Ingredient
Key Benefits
- Achieves high cure rates in previously untreated and treatment-experienced patients.
- Generally fewer side effects compared to older hepatitis C treatments, leading to better patient adherence.
- Simplified dosing with no need for ribavirin or interferon in most cases.
Direction of Use
- Typically, the recommended dose is one tablet daily for 8 to 24 weeks, depending on the specific patient profile and HCV genotype.
- Can be taken with or without food; swallowing the tablet whole is advised.
- Regular follow-ups and viral load assessments are recommended to evaluate treatment response.
Safety Concerns
- May include fatigue, headache, nausea, and insomnia.
- Sofosbuvir and ledipasvir can interact with other medications, particularly those that affect liver enzymes; consult a healthcare provider for guidance.
- Patients with a history of hepatitis B may experience reactivation; screening is necessary prior to treatment.
Avoid Harvoni (Sofosbuvir / Ledipasvir) If
- Known allergy to sofosbuvir, ledipasvir, or any other components of the formulation.
- Caution in patients with decompensated liver disease; alternative therapies may be required.
- In certain cases, other therapies may be preferred for patients co-infected with HIV.
- Avoid in combination with specific drugs that can adversely interact, such as strong inducers of CYP3A.
