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ADAFOSBUVIR
Generic Name: ADAFOSBUVIR
ABSTRACT -
Adafosbuvir, also known as AL-335, JNJ-335, or uprifosbuvir, is an investigational orally administered antiviral medicine studied for the treatment of chronic hepatitis C virus (HCV) infection. It is a uridine-based nucleotide phosphoramidate prodrug designed to inhibit the HCV nonstructural protein 5B (NS5B) RNA-dependent RNA polymerase. After administration, adafosbuvir is converted to intracellular nucleotide metabolites, including the active triphosphate form, which interferes with viral RNA synthesis and acts as a chain terminator. It has shown pangenotypic antiviral activity in early clinical studies, but it is not an approved routine therapy and should be used only under clinical-trial or specialist medical supervision.
DOSAGE -
Adafosbuvir is investigational and does not have a universally established approved dosage regimen.
- It has been administered orally as tablets or oral suspension in clinical studies.
- In a first-in-human study, single oral doses of 100 mg, 200 mg, 400 mg, 800 mg, and 1,200 mg were evaluated in healthy volunteers.
- In HCV-infected subjects, multiple oral doses of 400 mg, 800 mg, or 1,200 mg once daily were evaluated for 7 consecutive days under study protocol conditions.
- In later combination studies for chronic HCV infection, AL-335 doses of 400 mg to 800 mg once daily were evaluated with other direct-acting antivirals such as odalasvir with or without simeprevir for protocol-defined treatment durations.
- Dose, duration, food instructions, eligibility criteria, and safety monitoring must follow the clinical trial protocol or specialist investigator direction.
- It should not be used for self-medication or substituted for approved HCV therapy unless specifically prescribed in a controlled research or specialist setting.
SIDE EFFECTS –
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Reported or potential side effects may include:
- Headache
- Nasopharyngitis or upper respiratory tract infection symptoms
- Fatigue
- Nausea
- Diarrhea
- Abdominal discomfort
- Dizziness
- Palpitations
- Rash
- Increased liver enzymes such as alanine transaminase (ALT) or aspartate transaminase (AST)
- Laboratory abnormalities, including changes in creatine phosphokinase, glucose, calcium, phosphate, or cholesterol levels
- Cardiac conduction abnormality reported rarely in combination-study settings
- Allergic or hypersensitivity reactions
ALLRGIC REACTIONS–
The full interaction profile of adafosbuvir has not been completely established because it remains investigational. Use caution with medicines or therapies that may affect antiviral exposure, liver function, or cardiac safety, including:
- Other direct-acting antivirals, including odalasvir, simeprevir, or similar HCV medicines
- Strong enzyme or transporter inhibitors or inducers, including rifampin-like antibiotics, certain anticonvulsants, and herbal products such as St. John's wort
- Medicines associated with liver toxicity or significant changes in liver enzymes
- Antiretroviral medicines or other antiviral combinations
- Amiodarone or other medicines that may affect heart rhythm, especially when used with HCV antiviral combinations
- Other investigational medicines
- Alcohol or supplements that may worsen liver disease or alter liver metabolism
Patients should inform healthcare providers about all prescription medicines, non-prescription medicines, herbal products, and supplements being used.
DRUG INTERACTIONS–
- Use only in a clinical-trial, hepatology, infectious-disease, or specialist-supervised setting where laboratory and clinical monitoring can be performed.
- Confirm HCV infection status, genotype when required, baseline viral load, liver function, and cirrhosis status before treatment as directed by protocol.
- Screen and monitor for viral coinfections, including hepatitis B, when clinically appropriate, because antiviral therapy for HCV may require careful liver monitoring.
- Monitor liver enzymes, bilirubin, renal function, hematology, and other laboratory values as required by the study protocol or physician judgment.
- Consider electrocardiogram or cardiac monitoring if used with antiviral combinations or in patients with cardiac disease, palpitations, syncope, or medicines affecting heart rhythm.
- Use caution in patients with significant hepatic disease, decompensated cirrhosis, renal impairment, severe infection, unstable cardiovascular disease, or multiple serious comorbidities.
- Use during pregnancy or breastfeeding only if the potential benefit justifies the potential risk and as directed by a physician; contraception requirements should follow the clinical protocol, especially if combined with ribavirin or other agents with fetal risk.
- Safety and effectiveness in pediatric patients have not been established.
PREAUTIONS–
- Use only in a clinical-trial, hepatology, infectious-disease, or specialist-supervised setting where laboratory and clinical monitoring can be performed.
- Confirm HCV infection status, genotype when required, baseline viral load, liver function, and cirrhosis status before treatment as directed by protocol.
- Screen and monitor for viral coinfections, including hepatitis B, when clinically appropriate, because antiviral therapy for HCV may require careful liver monitoring.
- Monitor liver enzymes, bilirubin, renal function, hematology, and other laboratory values as required by the study protocol or physician judgment.
- Consider electrocardiogram or cardiac monitoring if used with antiviral combinations or in patients with cardiac disease, palpitations, syncope, or medicines affecting heart rhythm.
- Use caution in patients with significant hepatic disease, decompensated cirrhosis, renal impairment, severe infection, unstable cardiovascular disease, or multiple serious comorbidities.
- Use during pregnancy or breastfeeding only if the potential benefit justifies the potential risk and as directed by a physician; contraception requirements should follow the clinical protocol, especially if combined with ribavirin or other agents with fetal risk.
- Safety and effectiveness in pediatric patients have not been established.
WARNINGS –
- Adafosbuvir is an investigational medicine; safety, efficacy, optimal dose, and routine clinical role have not been fully established.
- Chronic hepatitis C can cause serious liver disease and should be managed with approved antiviral regimens unless the patient is enrolled in an appropriate specialist-supervised study.
- Clinically significant liver enzyme elevation, worsening liver function, severe fatigue, jaundice, dark urine, abdominal swelling, or unexplained bleeding requires prompt medical evaluation.
- Chest pain, fainting, severe palpitations, or suspected heart rhythm disturbance requires urgent evaluation, especially during combination antiviral therapy.
- Hypersensitivity reactions, including anaphylaxis, may occur.
- Treatment should be discontinued and urgent medical care sought if severe allergic reaction, severe adverse reaction, or clinical deterioration is suspected.
- Use only under medical supervision in a clinical-trial, hepatology, infectious-disease, or specialist setting.
- Keep out of reach of children.
- In case of overdose or severe adverse reaction, seek immediate emergency medical attention.
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