Edurant has finally got approval as the latest  non-nucleoside reverse transcriptase inhibitor for the treatment of HIV, Edurant helps in blocking reverse transcriptase an enzyme necessary for HIV replication

The drug, Edurant, , was approved for use in combination with other drugs in treating HIV patients who haven't been previously treated with other HIV drugs,

Edurant is made by Tibotec Therapeutics, which is part of Johnson & Johnson

Patients may respond differently to various HIV drugs or experience varied side effects, FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy. Edurant's approval is based on clinical studies that involved 1,368

adult patients with HIV infection. The studies compared Edurant to efavirenz, another HIV drug. Both Edurant and efavirenz were given in combination with other antiretroviral drugs.

The study showed Edurant was as effective as efavirenz in lowering viral load, FDA said. Among patients receiving Edurant, 83% of them had an undectable amount of HIV in their blood after 48 weeks of treatment compared to 80% of patients receiving efavirenz.

FDA said patients receiving Edurant who had a higher viral load at the start of therapy were more likely not to respond to the drug than were patients with a lower viral load at the start of therapy. The agency also said people who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.

The most commonly reported side effects in patients taking Edurant included depression and difficulty sleeping, headache and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.

The Warnings and Precautions for rilpivirine include fat redistribution, immune reconstitution syndrome and the following:

Depressive Disorder: The adverse reaction depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) has been reported. Most events were mild or moderate in severity.

Patients with severe depressive symptoms should seek immediate medical  assistance.

ADVERSE DRUG REACTIONS

The most common ADRs leading to discontinuation were psychiatric disorders: 10 (1%) subjects in the rilpivirine arm and 15 (2%) subjects in the efavirenz arm. Rash led to discontinuation in 1 (0.1%) subject in the rilpivirine arm and 10 (1.5%) subjects in the efavirenz arm

Rilpivirine is Pregnancy Category B (Animal reproduction studies have not shown a risk to the animal fetus but adequate and well-controlled trials in pregnant women have not been conducted). Rilpivirine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Safety and effectiveness in paediatric patients have not been established.

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