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 to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents

First Posted Date
2009-06-08
Last Posted Date
2012-09-03
Lead Sponsor
Tibotec Pharmaceuticals, Ireland
Target Recruit Count
12
Registration Number
NCT00915655

Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-05-28
Last Posted Date
2010-10-13
Lead Sponsor
Abbott
Target Recruit Count
8
Registration Number
NCT00909311
Locations
🇺🇸

Site Reference ID/Investigator# 19421, Waukegan, Illinois, United States

Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

First Posted Date
2009-05-04
Last Posted Date
2016-02-15
Lead Sponsor
Gilead Sciences
Target Recruit Count
85
Registration Number
NCT00892437
Locations
🇺🇸

Health for Life Clinic, PLLC, Little Rock, Arkansas, United States

🇺🇸

Therapeutic Concepts, P.A., Houston, Texas, United States

🇺🇸

AIDS Healthcare Foundation-Research Center, Beverly Hills, California, United States

and more 28 locations

GSK1349572 Drug Interaction Study With Atazanavir/Ritonavir and Atazanavir

First Posted Date
2009-04-20
Last Posted Date
2009-06-22
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
24
Registration Number
NCT00883935
Locations
🇺🇸

GSK Investigational Site, Austin, Texas, United States

Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women

First Posted Date
2009-03-26
Last Posted Date
2013-09-06
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
24
Registration Number
NCT00869960
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

GSK1349572 Drug Interaction With Etravirine and Either Darunavir/Ritonavir or Lopinavir/Ritonavir

First Posted Date
2009-03-23
Last Posted Date
2012-02-22
Lead Sponsor
ViiV Healthcare
Target Recruit Count
17
Registration Number
NCT00867152
Locations
🇺🇸

GSK Investigational Site, Buffalo, New York, United States

Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue

First Posted Date
2009-03-04
Last Posted Date
2011-05-13
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
13
Registration Number
NCT00855088
Locations
🇺🇸

UNC Hospitals CTRC, Chapel Hill, North Carolina, United States

HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine

First Posted Date
2009-03-04
Last Posted Date
2017-10-17
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
15
Registration Number
NCT00855413
Locations
🇺🇸

The University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

🇺🇸

Duke University, Durham, North Carolina, United States

Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters

First Posted Date
2009-02-26
Last Posted Date
2016-01-13
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
334
Registration Number
NCT00851799
Locations
🇺🇸

Harbor - UCLA Med. Ctr. CRS, Torrance, California, United States

🇺🇸

Northwestern University CRS (2701), Chicago, Illinois, United States

🇺🇸

Beth Israel Deaconess Med. Ctr., ACTG CRS, Boston, Massachusetts, United States

and more 23 locations
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