GI Top 300: Exam #1

What is the brand for Entecavir?

Baraclude

What is the drug class for Entecavir?

- Antiretroviral Agent

- Reverse Transcriptase Inhibitor

What are the dosage forms for Entecavir?

- Tablet

- Solution

What are the on-label uses for Entecavir?

Treatment of chronic HBV infection

What are the off-label uses for Entecavir?

HBV reinfection prophylaxis

What is the MOA for Entecavir?

- Intracellularly phosphorylated to GTP which competes with natural substrates to effectively inhibit HBV polymerase

- Blocks reverse transcriptase activity

- Reduces viral DNA synthesis

What are the box warnings for Entecavir?

- HIV resistance in chronic hepatitis B patients with unrecognized or untreated HIV infection

- Discontinuation of therapy may result in disease exacerbation

- Lactic acidosis

What are the contraindications for Entecavir?

None

Is Entecavir safe for pregnancy/lactation?

Pregnancy: Compatible (maternal benefit >> embryo-fetal risk)

Lactation: Contraindicated (in patients with HIV)

What are the adverse effects for Entecavir?

Edema, elevated LFTs

What is the brand for Sofosbuvir?

Sovaldi

What is the drug class for Sofosbuvir?

NS5B polymerase inhibitor

What are the dosage forms for Sofosbuvir?

- Tablet

- Oral Packet

What are the on-label uses for Sofosbuvir?

- Chronic hepatitis C (CHC) infection with genotypes 1, 2, 3, and 4 as part of combination therapy

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What are the off-label uses for Sofosbuvir?

Chronic hepatitis C (CHC) with any genotype

What is the MOA for Sofosbuvir?

- Direct-acting antiviral agent against the hepatitis C virus

- Inhibits HCV NS5B RNA-dependent RNA polymerase

- Essential for viral replication, and acts as a chain terminator.

What are the box warnings for Sofosbuvir?

HBV reactivation

What are the contraindications for Sofosbuvir?

Because of ribavirin risk, do not use in pregnant women, or men whose female partners are pregnant

Is Sofosbuvir safe for pregnancy/lactation?

Pregnancy: low risk

Lactation: probably compatible

What are the adverse effects for Sofosbuvir?

Fatigue, headache, insomnia, chills, pruritus, rash, nausea, anemia

What is the brand for Elbasvir-grazoprevir?

Zepatier

What is the drug class for Elbasvir-grazoprevir?

NS5A inhibitor + NS3/4A protease inhibitor

What are the dosage forms for Elbasvir-grazoprevir?

Tablet

What are the on-label uses for Elbasvir-grazoprevir?

Chronic hepatitis C (CHC) infection with genotype 1 or 4

What are the off-label uses for Elbasvir-grazoprevir?

None

What is the MOA for Elbasvir-grazoprevir?

- Elbasvir inhibits HCV NS5B RNA-dependent RNA polymerase,

- Grazoprevir inhibits NS3/4 protease

What are the box warnings for Elbasvir-grazoprevir?

HBV reactivation

What are the contraindications for Elbasvir-grazoprevir?

- Hepatic impairment

- Strong CYP3A4/5 inducers or OATP1B1/3 inhibitors

Is Elbasvir-grazoprevir safe for pregnancy/lactation?

Weigh risks and benefits

What are the adverse effects for Elbasvir-grazoprevir?

Fatigue, headache, nausea

What is the brand for Glecaprevir-pibrentasvir?

Mavyret

What is the drug class for Glecaprevir-pibrentasvir?

NS3/4A protease inhibitor + NS5A inhibitor

What are the dosage forms for Glecaprevir-pibrentasvir?

- Tablet

- Oral Packet

What are the on-label uses for Glecaprevir-pibrentasvir?

Chronic hepatitis C infection with genotype 1-6

What are the off-label uses for Glecaprevir-pibrentasvir?

Uninfected solid organ transplant recipient receiving hepatitis C virus positive donor

What is the MOA for Glecaprevir-pibrentasvir?

- Pibrentasvir inhibits hepatitis C virus NS5B RNA-dependent RNA polymerase

- Glecaprevir inhibits NS3/4 protease

What are the box warnings for Glecaprevir-pibrentasvir?

HBV reactivation in coinfected patients

What are the contraindications for Glecaprevir-pibrentasvir?

Hepatic impairment or history of hepatic decompensation, atazanavir, rifampin

Is Glecaprevir-pibrentasvir safe for pregnancy/lactation?

Weigh risks and benefits

What are the adverse effects for Glecaprevir-pibrentasvir?

Fatigue, headache, nausea, diarrhea

What is the brand for Hepatitis A vaccine?

Havrix, Vaqta

What is the drug class for Hepatitis A vaccine?

Inactivated Viral Vaccine

What are the dosage forms for Hepatitis A vaccine?

Intramuscular Suspension

What are the on-label uses for Hepatitis A vaccine?

Hepatitis A prophylaxis

What are the off-label uses for Hepatitis A vaccine?

- Hepatitis A postexposure prophylaxis for individuals 1-40 years of age

- Outbreak control:

What are the box warnings for Hepatitis A vaccine?

None

What are the contraindications for Hepatitis A vaccine?

Is Hepatitis A vaccine safe for pregnancy/lactation?

Pregnancy: compatible

Lactation: compatible

What are the adverse effects for Hepatitis A vaccine?

Injection site reactions, including erythema, swelling and soreness, headache, irritability, somnolence

What is the brand for Hepatitis B vaccine?

Engerix-B, Recombivax HB, HEPLISAV-B

What is the drug class for Hepatitis B vaccine?

Inactivated Viral Vaccine

What are the dosage forms for Hepatitis B vaccine?

Suspension for Intramuscular Injection

What are the on-label uses for Hepatitis B vaccine?

Prevention of hepatitis B infection

What are the off-label uses for Hepatitis B vaccine?

Mass casualty events

What are the box warnings for Hepatitis B vaccine?

None

What are the contraindications for Hepatitis B vaccine?

Hypersensitivity to hepatitis B vaccine or a component of the vaccine (some formulations may contain yeast)

Is Hepatitis B vaccine safe for pregnancy/lactation?

Pregnancy: compatible

Lactation: compatible

What are the adverse effects for Hepatitis B vaccine?

Injection site reactions, including erythema and soreness, fatigue