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
-

Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1

First Posted Date
2009-02-24
Last Posted Date
2017-11-20
Lead Sponsor
AbbVie
Target Recruit Count
87
Registration Number
NCT00850044
Locations
🇺🇸

Site Reference ID/Investigator# 15981, Waukegan, Illinois, United States

Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants

First Posted Date
2009-02-02
Last Posted Date
2012-10-25
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
185
Registration Number
NCT00833482
Locations
🇺🇸

West Coast Clinical Trials, Llc, Cypress, California, United States

🇳🇱

Local Institution, Nijmegen, Netherlands

Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir

First Posted Date
2009-01-06
Last Posted Date
2020-11-12
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
24
Registration Number
NCT00817765
Locations
🇳🇱

Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland, Netherlands

Comparative Study of Three NNRTI-Sparing HAART Regimens

First Posted Date
2008-12-19
Last Posted Date
2014-09-05
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
1814
Registration Number
NCT00811954
Locations
🇺🇸

The Ponce de Leon Center CRS, Atlanta, Georgia, United States

🇺🇸

The Ohio State Univ. AIDS CRS, Columbus, Ohio, United States

🇺🇸

Trinity Health and Wellness Center, Dallas, Texas, United States

and more 54 locations

An Interaction Study to Assess Drug Levels in Fasting Healthy Adult Subjects

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2008-12-04
Last Posted Date
2016-01-29
Lead Sponsor
Garden State Infectious Disease Associates, PA
Target Recruit Count
45
Registration Number
NCT00802074
Locations
🇺🇸

Garden State Infectious Disease Associates, PA, Voorhees, New Jersey, United States

To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil

First Posted Date
2008-10-09
Last Posted Date
2009-12-02
Lead Sponsor
VIVUS LLC
Target Recruit Count
44
Registration Number
NCT00770042
Locations
🇺🇸

Research Site, Lincoln, Nebraska, United States

Phase IIB Pilot of Atazanavir + Raltegravir

First Posted Date
2008-10-08
Last Posted Date
2012-02-24
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
167
Registration Number
NCT00768989
Locations
🇺🇸

Orlando Immunology Center, Orlando, Florida, United States

🇫🇷

Local Institution, Paris Cedex 20, France

🇺🇸

Yale University School Of Medicine, New Haven, Connecticut, United States

and more 7 locations

NNRTI/PI Toxicity Switch to Darunavir Study

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2008-10-02
Last Posted Date
2010-11-01
Lead Sponsor
St Stephens Aids Trust
Target Recruit Count
12
Registration Number
NCT00765154
Locations
🇬🇧

Chelsea and Westminster Hospital, London, United Kingdom

An Interaction Study to Assess Drug Levels in Healthy Adult Subjects

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-10-02
Last Posted Date
2016-01-29
Lead Sponsor
Garden State Infectious Disease Associates, PA
Target Recruit Count
45
Registration Number
NCT00764465
Locations
🇺🇸

Garden State Infectious Disease Associates,PA, Voorhees, New Jersey, United States

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