Pharmaceutical company ViiV Healthcare has been granted Japanese approval for its treatment of HIV-1 as a combination therapy.
The approval comes from the Ministry of Health, Labour and Welfare (MHLW) in Japan and enables the company’s Vocabria (cabotegravir injection and tablets) to be used in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys and Edurant .
Cabotegravir is an integrase strand transfer inhibitor (INSTI) which has already been approved as long-acting formulation for HIV-1 in combination with the injectable Rekambys.
INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This is an essential step in the HIV replication cycle and is also responsible for establishing chronic infection.
The approval for Vocabria as a combination therapy means that it is now a long-acting treatment option for patients living with HIV in Japan. It will be used to treat patients with HIV-1who will be placed on a stable regimen and have no history of treatment failure and with no known or suspected resistance to either Vocabria or Rekambys.
ViiV Healthcare says that the long-acting treatment will enable HIV-1 patients to reduce the days they receive treatment from 365 days per to 12 or six.
Deborah Waterhouse, CEO of ViiV Healthcare said: “At ViiV Healthcare, we are committed to leading innovation in HIV treatment to offer solutions to match the needs of people living with HIV. By removing the need for daily oral treatment, the approval of cabotegravir injection and rilpivirine long-acting is an important development for the HIV community and reinforces our efforts to provide new treatment options so that no person living with HIV is left behind. We look forward to working closely with partners over the next few years to make this treatment available to people who could benefit from long-acting treatment in Japan.”