Combination of | |
---|---|
Ledipasvir | NS5A inhibitor |
Sofosbuvir | NS5B (RNA polymerase) inhibitor |
Clinical data | |
Trade names | Harvoni, Hepcinat-LP, others |
AHFS/Drugs.com | Monograph |
Pregnancy category |
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Routes of administration |
by mouth |
ATC code | |
Legal status | |
Legal status |
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Ledipasvir/sofosbuvir, sold under the trade name Harvoni among others, is a medication used to treat hepatitis C. It is a combination of ledipasvir and sofosbuvir. Cure rates are 94% to 99% in people infected with hepatitis C virus (HCV) genotype 1. Some evidence also supports use in HCV genotype 3 and 4. It is taken daily by mouth for 8–24 weeks.
It is generally well tolerated. Common side effects include muscle pains, headache, nausea, rash, and cough. It is unclear if use in pregnancy is safe for the baby. Ledipasvir works by decreasing the activity of NS5A and sofosbuvir works by decreasing the activity of NS5B polymerase.
Ledipasvir/sofosbuvir was approved for medical use in the United States in 2014. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. The wholesale cost in the United States is about US$91,589.40 for 12 weeks as of 2016. In Bangladesh this amount costs US$1,092.00. Some people travel to India to get access to lower cost medication.
Cure rates are 94% to 99% in people infected with genotype 1. It has also been evaluated for the treatment of infection with other hepatitis C genotypes, and has shown promising results in genotypes 3 and 4.
It should not be used with amiodarone or other drugs that lower heart rate; there is a serious risk of the heart slowing or stopping when ledipasvir/sofosbuvir is used with such drugs.
More than 10% of people taking ledipasvir/sofosbuvir have headaches or fatigue; rashes, nausea, diarrhea, and insomnia occur in between 1% and 10% of people taking it.
More severe reactions are connected with allergic reactions to the medications and cardiovascular problems. Harvoni side effects are considered relatively mild compared to older interferon-based treatment.