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ViiV Healthcare gets Japanese marketing approval for Vocabria used in combo with Rekambys to treat HIV

London, UK
Wednesday, June 1, 2022, 11:00 Hrs  [IST]

ViiV Healthcare, the global specialist HIV company majority-owned by GSK with Pfizer and Shionogi as shareholders, announced it obtained approval for Vocabria (cabotegravir injection and tablets) used in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine long-acting injectable suspension) and Edurant (rilpivirine tablets), the first and only complete long-acting treatment for HIV, from the Ministry of Health, Labour and Welfare (MHLW) in Japan. Cabotegravir injection used in combination with rilpivirine long-acting is indicated to treat human immunodeficiency virus type 1  (HIV-1) infection in adults who are virologically suppressed, on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Data from one of the most extensive global HIV patient-reported outcomes studies, Positive Perspectives 2 sponsored by ViiV Healthcare, reinforces the need for less frequent dosing for HIV treatments. When participants were asked about their treatment aspirations and attitudes towards innovative medications, 55% (n = 1,306/2,389) said they would prefer not having to take medication every day, if their HIV stays suppressed. In addition, 58% (n = 1,394/2,389) noted that taking daily HIV medication acts as a constant reminder of HIV in their lives. In comparison, up to 38% (n = 906/2,389) of participants reported anxiety around the fact that taking daily treatment could increase the chances of revealing their HIV status to others.

An estimated 30,000 people are living with HIV in Japan, and the prevalence continues to rise, with more than 1,000 new cases per year. In Japan, HIV prevalence remains an issue that must be addressed. While the prognosis for people living with HIV has improved due to advances in treatment, adherence to long-term medication and the challenges of ageing have become issues for the community.  

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.”

ViiV Healthcare’s mission is to leave no person living with HIV behind. As the only pharmaceutical company solely focused on HIV and AIDS, ViiV Healthcare is working to deliver a broad range of treatments that meet the needs of a wide variety of people living with HIV. ViiV Healthcare’s cabotegravir, in combination with Janssen’s rilpivirine was co-developed as part of a collaboration with Janssen and builds on ViiV Healthcare’s industry-leading portfolio centred on delivering innovative medicines for the HIV community.

Cabotegravir is an integrase strand transfer inhibitor (INSTI) developed by ViiV Healthcare for the treatment of HIV-1 in virologically suppressed adults. It is approved as a long-acting formulation in combination with injectable rilpivirine.

INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

The oral formulation of rilpivirine is also authorised for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35kg with a viral load =100,000 HIV RNA copies/mL.

Rilpivirine long-acting is a prolonged-release suspension for intramuscular injection developed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.

Cabotegravir injection used in combination with rilpivirine injection is a complete long-acting regimen dosed once-monthly or once every 2-months for virologically suppressed people living with HIV-1. Cabotegravir and rilpivirine injections are administered as two intramuscular (IM) injections in the buttocks by a healthcare professional at the same appointment. Prior to the initiation of the injections, cabotegravir and rilpivirine oral tablets are taken for approximately one month (at least 28 days) to assess tolerability to the medicines.

For monthly dosing, the usual adult dosage is 600 mg of cabotegravir administered intramuscularly in the gluteal site with rilpivirine long-acting. Thereafter, 400 mg should be intramuscularly administered in the gluteal site monthly. For every two-month dosing, the usual adult dosage is 600 mg of cabotegravir administered intramuscularly in the gluteal site with rilpivirine long-acting. One month after the initial dosing of cabotegravir injection, 600 mg should be intramuscularly administered in the gluteal site. Thereafter, 600 mg should be intramuscularly administered in the gluteal site every two months.

 

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