ViiV Healthcare announced that the European Commission approved Vocabria (cabotegravir injection and tablets) in combination with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets) for HIV treatment. The drug is approved for the treatment of HIV-1 infection in adults who are virologically suppressed.
The approval is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) ATLAS-2M studies.
Among the trials, 55% of patients preferred not to take medication every day, 58% of patients said that taking medication every day reminds them of being HIV infected, 38% of patients reported anxiety while taking medicine every day.
Vocabria reduces the days on which the drug is administered from 365 days to 12 or 6 times per year. Vocabria is the first long-acting injection, avoiding taking daily oral tablets following the initiation phase.
Cabotegravir is an integrase strand transfer inhibitor, prevents the integration of viral DNA with the host genetic material. This step is essential for the replication of the virus.