Well at least there is some progress in treating one of the world’s deadliest epidemics. This week the U.S. Food and Drug Administration (FDA) today approved Edurant, or rilpivirine, in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV treatments. These patients are also known as “treatment naive.”

Edurant works by blocking HIV viral replication.

AIDS was first reported in the United States in 1981 and has since become a major worldwide epidemic. AIDS is caused by the human immunodeficiency virus, or HIV. By killing or damaging cells of the body’s immune system, HIV progressively destroys the body’s ability to fight infections and certain cancers. People diagnosed with AIDS may get life-threatening diseases called opportunistic infections. These infections are caused by microbes such as viruses or bacteria that usually do not make healthy people sick.

Edurant, in combination with other medications, is designed to block the ability of the HIV virus to integrate into the genetic material of human cells which replicates the organisms’ own DNA in the steps listed below:

  1. Fusion of the HIV cell to the host cell surface.
  2. HIV RNA, reverse transcriptase, integrase, and other viral proteins enter the host cell.
  3. Viral DNA is formed by reverse transcription.
  4. Viral DNA is transported across the nucleus and integrates into the host DNA.
  5. New viral RNA is used as genomic RNA and to make viral proteins.
  6. New viral RNA and proteins move to cell surface and a new, immature, HIV virus forms.
  7. The virus matures by protease releasing individual HIV proteins.

Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research said:

“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 does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses. Edurant (rilpivirine) is taken once-daily as a 25 mg pill. The approval is based on clinical trial results showing that Edurant is as effective as Sustiva (efavirenz), which is also an NNRTI. The most commonly reported side effects of Edurant are depression, difficulty sleeping (insomnia), headache, and rash.

After 48 weeks of study, 83% of patients taking Edurant had undetectable viral levels, compared with 80% of patients taking Sustiva.

Source: The U.S. Food and Drug Administration

Written by Sy Kraft