Ritonavir

Generic Name
Ritonavir
Brand Names
Kaletra, Norvir, Paxlovid, Viekira Pak, Ritonavir Mylan
Drug Type
Small Molecule
Chemical Formula
C37H48N6O5S2
CAS Number
155213-67-5
Unique Ingredient Identifier
O3J8G9O825
Background

Ritonavir is an HIV protease inhibitor that interferes with the reproductive cycle of HIV. Although it was initially developed as an independent antiviral agent, it has been shown to possess advantageous properties in combination regimens with low-dose ritonavir and other protease inhibitors. It is now more commonly used as a booster of other protease inhibitors and is available in both liquid formulations and as capsules.

While ritonavir is not an active antiviral agent against hepatitis C virus (HCV) infection, it is added in combination therapies indicated for the treatment of HCV infections as a booster. Ritonavir is a potent CYP3A inhibitor that increases peak and trough plasma drug concentrations of other protease inhibitors such as Paritaprevir and overall drug exposure. American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) guidelines recommend ritonavir-boosted combination therapies as first-line therapy for HCV Genotype 1a/b and 4 treatment-naïve patients with or without cirrhosis.

Ritonavir is found in a fixed-dose combination product with Ombitasvir, Dasabuvir, and Paritaprevir as the FDA-approved product Viekira Pak. First approved in December 2014, Viekira Pak is indicated for the treatment of HCV genotype 1b without cirrhosis or with compensated cirrhosis, and when combined with Ribavirin for the treatment of HCV genotype 1a without cirrhosis or with compensated cirrhosis.

Ritonavir is also available as a fixed-dose combination product with Ombitasvir and Paritaprevir as the FDA- and Health Canada-approved product Technivie. First approved in July 2015, Technivie is indicated in combination with Ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.

In Canada, ritonavir is also available as a fixed-dose combination product with Ombitasvir, Dasabuvir, and Paritaprevir as the Health Canada-approved, commercially available product Holkira Pak. First approved in January 2015, Holkira Pak is indicated for the treatment of HCV genotype 1b with or without cirrhosis, and when combined with Ribavirin for the treatment of HCV genotype 1a with or without cirrhosis. The inclusion of ritonavir can select for HIV-1 protease inhibitor resistance-associated substitutions. Any HCV/HIV-1 co-infected patients treated with ritonavir-containing combination therapies should also be on a suppressive antiretroviral drug regimen to reduce the risk of HIV-1 protease inhibitor drug resistance.

Ritonavir is combined with other drugs to treat coronavirus disease 2019 (COVID-19) in patients at risk for progressing into a severe form of the disease, such as nirmatrelvir.

Indication

Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

In the US, Europe, and Canada, ritonavir, in combination with nirmatrelvir, is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. In Europe, this therapeutic indication is approved under conditional marketing authorization.

Associated Conditions
Chronic hepatitis C genotype 1a, Chronic hepatitis C genotype 1b, Human Immunodeficiency Virus Type 1 (HIV-1) Infection, Mild, moderate Novel Coronavirus Infectious Disease (COVID-19)
Associated Therapies
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A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers

First Posted Date
2012-01-26
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
40
Registration Number
NCT01519336

A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers

First Posted Date
2012-01-23
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
18
Registration Number
NCT01514968

A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-12-01
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
36
Registration Number
NCT01483729

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

First Posted Date
2011-11-21
Last Posted Date
2016-06-08
Lead Sponsor
Gilead Sciences
Target Recruit Count
438
Registration Number
NCT01475838
Locations
🇺🇸

Peter J. Ruane, M.D., Inc., Los Angeles, California, United States

🇺🇸

OASIS Clinic, Los Angeles, California, United States

🇺🇸

Gordon Crofoot Md, Pa, Houston, Texas, United States

and more 94 locations

ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

First Posted Date
2011-11-04
Last Posted Date
2015-04-22
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
580
Registration Number
NCT01464827
Locations
🇺🇸

Site Reference ID/Investigator# 55527, Marietta, Georgia, United States

🇺🇸

Site Reference ID/Investigator# 43661, Jackson, Mississippi, United States

🇺🇸

Site Reference ID/Investigator# 56622, Philadelphia, Pennsylvania, United States

and more 94 locations

A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers

First Posted Date
2011-08-17
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
20
Registration Number
NCT01418274

Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

First Posted Date
2011-07-22
Last Posted Date
2024-10-11
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
262
Registration Number
NCT01400412
Locations
🇺🇸

University of Colorado Hospital CRS (6101), Aurora, Colorado, United States

🇺🇸

Univ. of South Florida (USF) College of Medicine ATN CRS (33001), Tampa, Florida, United States

🇺🇸

Washington U CRS (2101), Saint Louis, Missouri, United States

and more 35 locations
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