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Ravidasvir
Ravidasvir

Ravidasvir(盐酸拉维达韦片)

Ravidasvir hydrochloride is a next-generation pan-genotypic NS5A inhibitor that exerts potent antiviral activity by inhibiting the function of the hepatitis C virus (HCV) NS5A protein and blocking viral RNA replication and virion assembly.

  • 0.2g*14tablets

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Introduction of Ravidasvir

Ravidasvir hydrochloride features a high genetic barrier to resistance and exhibits favorable efficacy in patients with baseline NS5A resistance mutations. It was included in the WHO Guidelines for the Treatment of Hepatitis C in 2025 and has become one of the recommended treatment regimens.

Indications

Ravidasvir Hydrochloride Tablets in combination with ritonavir-boosted Danoprevir Sodium Tablets and ribavirin, is indicated for the treatment of treatment-naive adult patients with non-cirrhotic chronic hepatitis C virus (HCV) infection of genotype 1b.

Ravidasvir Hydrochloride Tablets should not be used as monotherapy.

Overview

Generic Name
Ravidasvir Hydrochloride Tablets,盐酸拉维达韦片
Brand Name
Asclevir,新力莱
Drug Type
Rx Drug
Approval No.
国药准字H20200008
Active Ingredient
Ravidasvir Hydrochloride
Dosage Form
0.2g*14tablets
Specification
Tablets
Description
Ravidasvir Hydrochloride Tablets are film-coated tablets, which appear off-white to yellow after the coating is removed.
Expiry Date
24 months
Manufacturer
Ascletis Pharma (Zhejiang) Co., Ltd.
Storage
Store sealed at a temperature not exceeding 25℃.

Dosage and Administration

Recommended Dosage

Ravidasvir Hydrochloride Tablets are administered orally, either on an empty stomach or with food, at a dose of 200mg once daily for 12 consecutive weeks. This product must be used in combination with Danoprevir Sodium Tablets, ritonavir and ribavirin during administration.

Recommended dosage of Danoprevir Sodium Tablets: Administered orally, 100mg twice daily for 12 consecutive weeks (see the package insert for Danoprevir Sodium Tablets for details).

Recommended dosage of Ritonavir (RTV): Administered orally, 100mg twice daily for 12 consecutive weeks (see the package insert for Ritonavir Tablets for details).

Recommended dosage of Ribavirin: The dosage is determined by body weight. For patients with a body weight <75kg, 500mg twice daily; for patients with a body weight ≥75 kg, 600mg twice daily, both for 12 consecutive weeks (see the package insert for ribavirin preparations for details).

Dose Adjustment, Treatment Interruption and Discontinuation

Dosage adjustment of Ravidasvir Hydrochloride Tablets is not recommended, and treatment interruption of this product should be avoided. If treatment with any drug in the combination therapy regimen needs to be interrupted due to adverse reactions, Ravidasvir Hydrochloride Tablets must not be used alone.

Contraindications

This product is contraindicated in patients with a previous hypersensitivity to this product or any of its ingredients.

For contraindications associated with the combined use of this product and other drugs, refer to the package inserts of the respective drugs.

Adverse Reactions

During the study of CTR20160969, most abnormal results of hematological tests were Grade 1 or Grade 2. Only two cases of abnormal complete blood count results with a severity of Grade 3 or above were reported in the trial group: one case was decreased neutrophil count, which was assessed by the investigator as unrelated to treatment; the other case was decreased white blood cell count, which subsequently progressed to Grade 4 neutropenia and was assessed by the investigator as possibly related to treatment.

During the study of CTR20160969, most abnormal results of blood biochemical tests were Grade 1 or Grade 2. A total of three cases of Grade 3 abnormal blood biochemical test results related to treatment were reported in the trial group, all of which were elevated blood bilirubin. One case of Grade 4 abnormal blood biochemical test result occurred in the trial group, which was elevated serum uric acid.

Special Populations

Pregnancy and Lactation

There are no available data on the use of this product in pregnant women. Animal studies have demonstrated potential teratogenic effects of this product, while the potential risk in humans remains unknown. Use of this product in pregnant women is not recommended.

It is unknown whether this product and its excipients are excreted in human milk. Therefore, lactating women should use this product with caution, and discontinuation of breastfeeding is recommended.

Pediatric Use

There are no available research data on the safety and efficacy of this product in pediatric patients.

Geriatric Use

There are no available research data on the safety and efficacy of this product in geriatric patients.

For more detailed drug information, please consult the official package leaflet.

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