Harvoni is a combination of ledipasvir and sofosbuvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It may sometimes be used with another antiviral medication (ribavirin). These drugs work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.

It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice “safer sex” (including the use of latex condoms) to lower the risk of passing the virus to others.


How to use Harvoni

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking Harvoni and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight.

If you are using the pellet form of this medication, gently shake the packet before use. To take this medication without food, open the packet and pour the pellets directly into your mouth. Swallow the pellets without chewing. You may drink water after swallowing the pellets if needed. Repeat these steps if your dose is for more than one packet. If you are taking this medication with food, open the packet(s) and pour the pellets into a small bowl with one or more spoonfuls of non-acidic soft food (such as pudding, mashed potato, ice cream). The soft food should be at or below room temperature. After gently mixing, take all of the mixture without chewing within 30 minutes.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Tell your doctor if you vomit within 5 hours after taking this medication. You may need to take another dose. Continue to take Harvoni for the full length of time prescribed, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.

Antacids lower the absorption of ledipasvir. If you are taking an antacid, take it at least 4 hours before or 4 hours after this medication. Other acid-lowering medications for indigestion, heartburn, or ulcers (such as prescription or over-the-counter medications including famotidine, omeprazole) may prevent ledipasvir from working. Ask your doctor or pharmacist how to use these medications safely.

Fake Harvoni
Fake Harvoni

How to Spot Fake Harvoni

Falsified versions of the fixed-dose combination preparation ledipasvir/sofosbuvir (Harvoni®) were identified in Brazil in May 2020 and in Turkey in November 2020. The World Health Organization (WHO) has received recent information suggesting that these products are still in circulation. Available information indicates that these falsified medicines were supplied at patient level. It has been confirmed that the identified fake preparations have been falsified on the basis that they deliberately/fraudulently misrepresent their identity, composition or origin.

The genuine manufacturer “Gilead Sciences” has confirmed it did not produce the product referenced in the WHO Medical Product Alert n°7/2020 and the variable data (batch number and expiry dates) of these products do not correspond to genuine manufacturing records. Photographs of falsified Harvoni® identified in Turkey are shown below. They show labels written in German language. For more details, please refer to the relevant WHO alert at https://www.who.int/…/08-12-2020-medical-product-alert…

WHO requests increased vigilance within the supply chains in countries likely to be affected by these falsified products in the WHO regions of the Americas and Europe. Increased vigilance should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies and any other suppliers of medical products. All medical products must be obtained from authorized/licensed and reliable suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional in case of doubt. If you are in possession of the above falsified products, please do not use them.

If you have used these falsified products, or you suffered an adverse reaction/event having used these products, you are advised to seek immediate medical advice from a qualified healthcare professional, and to report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre. National regulatory/health authorities are advised to immediately notify WHO if these falsified products are identified in their country.

If you have any information concerning the manufacture, distribution, or supply of these fake products, then contact rapidalert@who.int       Recommended Reading Alcoholic Hepatitis

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