US FDA removes need for oral lead-in with long-acting cabotegravir/rilpivirine injections: indication expanded to adolescents

Simon Collins, HIV i-Base

On 24 March 2022, the US FDA announced that the need to use one month on oral formulations of cabotegravir and rilpivirine, before using the long-acting injectable formulations, is now optional. [1]

Until now, the oral lead-in has been a safety requirement to reduce the risk of a hypersensitivity reaction or other side effects from drugs that have an extremely long half-life and that are not otherwise removeable.

Oral formulations will still be available for people who want to use this additional safety option.

A few days later, the US FDA also extended the indication from adults to also include adolescents who are 12 years or older and weighing at least 35 kg. [2]

For more details please refer to the full prescribing information.


  1. ViiV Healthcare. ViiV Healthcare announces label update for its long-acting HIV treatment, Cabenuva (cabotegravir, rilpivirine), to be initiated with or without an oral lead-in period. (24 March 2022).
  2. ViiV Healthcare. ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for virologically suppressed adolescents living with HIV who are 12 years of age or older and weigh at least 35 kg. (29 March 2022).

This report was first published on 24 March 2022.

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