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  • ViiV Healthcare announces the marketing authorisat...

ViiV Healthcare announces the marketing authorisation of the first complete long-acting injectable HIV treatment, Vocabria + Rekambys + Edurant in Europe.

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Published:22nd Dec 2020
ViiV Healthcare, announced the authorisation of Vocabria (cabotegravir injection and tablets) in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union, for the treatment of HIV-1 infection in adults who are virologically suppressed. Cabotegravir injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the nnrti and ini class. this authorisation represents the first time people living with hiv in europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase. outlining the need for a less frequent dosing regimen, the largest global hiv patient-reported outcomes study to date conducted by viiv healthcare, positive perspectives wave 2, found that when participants were asked about their treatment aspirations and attitudes towards innovative medications, 55% (n="1306/2389)" would prefer not having to take medication every day, as long as their hiv stays suppressed. in addition, 58% (n="1394/2389)" noted that taking daily hiv medication acts as a constant reminder of hiv in their lives, while up to 38% (n="906/2389)" of participants reported anxiety around the fact that taking daily treatment could increase the chances of revealing their hiv status to others. marketing authorisation is based on the pivotal phase iii atlas (antiretroviral therapy as long-acting suppression), flair (first long-acting injectable regimen) and atlas-2m studies, which included more than 1,200 participants from 16 countries. cabotegravir and rilpivirine are co-administered as two intramuscular (im) injections in the buttocks by a healthcare professional at the same appointment..>
Condition: HIV/AIDS
Type: drug

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