Ombitasvir Paritaprevir Ritonavir Brand Name– Technivie
What is Ombitasvir Paritaprevir Ritonavir
Ombitasvir Paritaprevir Ritonavir is a combination oral product for use with ribavirin to treat genotype 4 hepatitis C virus (HCV) infections in patients without cirrhosis or with compensated cirrhosis.
The product combines 3 different drugs in a single tablet, which is administered once daily with a meal. Of the 3 drugs, 2 are antiviral agents with direct active against genotype 4 HCV and non-overlapping resistance profiles, ombitasvir (NS5A inhibitor) and paritaprevir (NS3/4A protease inhibitor).
The other drug, ritonavir, is not active against HCV, but instead acts as a potent CYP3A inhibitor to increase exposure of paritaprevir.
Approval was based on the results of two clinical trials. In the first trial (PEARL-I), 135 non-cirrhotic adults with genotype 4 HCV infection were randomized to receive ombitasvir; paritaprevir; ritonavir either with or without ribavirin for 12 weeks. The primary endpoint was a sustained virologic response (SVR) at week 24 (i.e., 12 weeks after cessation of drug therapy).
The primary end point was achieved by 100% (n = 91/91) of patients treated with the combination product plus ribavirin and 91% (n = 40/44) of patients receiving the study drug without ribavirin.
The second trial (AGATE-I), evaluated the efficacy of ombitasvir; paritaprevir; ritonavir plus ribavirin for 12 weeks in 120 genotype 4 HCV infected adults with compensated cirrhosis. Data from this trial found 97% (n = 57/59) of the drug recipients maintained a SVR at 12 weeks after cessation of drug therapy.
Of the trial subjects who did not achieve SVR, 1 was deemed an on-treatment virologic failure and 1 prematurely discontinued treatment due to non-compliance.
The manufacturer recommends Ombitasvir Paritaprevir Ritonavir be used with ribavirin; however, for non-cirrhotic treatment-naive patients who are unable to tolerate ribavirin, consideration may be given to treatment without ribavirin.
The drug is contraindicated for use in patients with moderate to severe hepatic disease (Child-Pugh Class B and C).
Ombitasvir Paritaprevir Ritonavir was FDA-approved in July 2015.
Indications
- hepatitis C infection
- hepatitis C virus
Side Effects
- abdominal pain
- agitation
- anemia
- angina
- angioedema
- anorexia
- anxiety
- arthralgia
- ascites
- asthenia
- atrial fibrillation
- back pain
- chest pain (unspecified)
- contact dermatitis
- cough
- depression
- dizziness
- dyspnea
- edema
- elevated hepatic enzymes
- erythema
- erythema multiforme
- fatigue
- headache
- hepatic failure
- hepatitis B exacerbation
- hyperbilirubinemia
- hypertension
- hypotension
- insomnia
- irritability
- jaundice
- maculopapular rash
- mania
- memory impairment
- myalgia
- nausea
- palpitations
- peripheral edema
- photosensitivity
- pruritus
- psoriasis
- rash
- serious hypersensitivity reactions or anaphylaxis
- skin ulcer
- suicidal ideation
- urticaria
- vomiting
- weakness
- xerosis
Monitoring Parameters
- hepatitis B serology
- LFTs
- plasma hepatitis C RNA
- plasma HIV RNA
- pregnancy testing
- serum bilirubin
Contraindications
- anticoagulant therapy
- breast-feeding
- cardiac disease
- cerebrovascular disease
- contraception requirements
- hepatic disease
- hepatitis B exacerbation
- hepatitis C and HIV coinfection
- infertility
- male-mediated teratogenicity
- pregnancy
- pregnancy testing
- use with ribavirin
Interactions
- Abacavir
- Abacavir; Dolutegravir; Lamivudine
- Abacavir; Lamivudine, 3TC
- Abacavir; Lamivudine, 3TC; Zidovudine, ZDV
- Abemaciclib
- Acalabrutinib
- Acarbose
- Acebutolol
- Acetaminophen
- Acetaminophen; Aspirin, ASA; Caffeine
- Acetaminophen; Butalbital
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine
- Acetaminophen; Caffeine; Dihydrocodeine
- Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
- Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
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- Acetaminophen; Codeine
- Acetaminophen; Dextromethorphan
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- Acetaminophen; Oxycodone
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- grapefruit juice
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