VIREAD (tenofovir disoproxil fumarate) is a nucleotide analog reverse transcriptase inhibitor used for the treatment of HIV-1 infection as well as chronic Hepatitis B virus (HBV) infection, always in combination with other antiretroviral drugs. VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. VIREAD disrupts viral replication via deoxyribonucleic acid (DNA) chain termination.
Dosing & Administration
VIREAD is indicated for the treatment of HIV-1 infection and the treatment of chronic HBV infection in adults and children age 2 and up and weighing at least 10kg. It is also used off-label for HIV post-exposure prophylaxis following occupational or non-occupational exposure. VIREAD comes in oral tablet and oral powder formulations.
No dosage adjustments are required in patients with liver dysfunction, but the drug should be used with caution due to risk of hepatotoxicity. VIREAD dosage adjustments are required for patients with renal impairment. Details can be found in the package insert.
VIREAD has no specific contraindications, other than as suggested in the product precautions.
In HIV-infected patients, reports of the most common adverse reactions included rash, diarrhea, nausea, headache, pain, depression, and asthenia.
In HBV-infected patients with compensated liver disease, the most common adverse reaction was nausea.
In HBV-infected patients with decompensated liver disease, the most common adverse reactions included abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia.
This product has shown new onset or worsening of renal impairment. VIREAD should not be administered with concurrent or recent use of nephrotoxic drugs. VIREAD has shown immune reconstitution syndrome which might require evaluation and treatment. Decreases in bone mineral density (BMD) have been reported. BMD assessments should be considered in patients with a relevant history or risk factors for osteoporosis or bone loss. Lactic acidosis/severe hepatomegaly with steatosis have been reported. Treatment should be stopped for those patients with symptoms or laboratory findings.
HIV testing should be done for all HBV-infected patients before starting therapy with VIREAD. Hepatic function should be monitored closely in HBV-infected patients who discontinue VIREAD.
VIREAD is associated with a number of drug-drug interactions and prescribers should familiarize themselves with the list provided in the package insert.
Pregnancy & Lactation
There is a pregnancy exposure registry that is in place to monitor pregnancy outcomes in women exposed to VIREAD during pregnancy.
Breastfeeding in HIV-1 infected mothers is not recommended due to the potential for HIV-1 transmission. This product has been shown to be present in human breast milk. It is not known if it affects milk production or has effects on the breastfed child.
VIREAD is efficiently removed by hemodialysis.
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