Antiretroviral therapy has to be taken lifelong by people living with HIV. Missing doses and stopping and re-starting treatment can lead to drug resistance, which can allow HIV to multiply and progress to AIDS disease.
That is why ongoing research and development of long-acting antiretroviral therapy is so vital because then people living with HIV may not have to take oral tablets daily at the same time. Instead, they have the option to go for long-acting antiretroviral medicines.
The most advanced HIV treatment available today is a two-drug long-acting injectable antiretroviral-based regimen consisting of Rilpivirine and Cabotegravir that reduces the burden of treatment to just six or twelve injections per year. Long-acting injectable Cabotegravir and Rilpivirine antiretroviral drugs are administered as separate injections once every month or every two months. This regimen can be used by adults living with HIV who have been on oral antiretroviral therapy and are virally suppressed for at least three months.
Two studies- ATLAS and FLAIR- compared if long-acting injectable antiretroviral medicines (Cabotegravir and Rilpivirine) have the same efficacy, safety and tolerability, as the oral daily antiretroviral medicines taken by people living with HIV. Both these studies found that whether a person takes daily oral medication or long-acting injectables, efficacy, safety and tolerability, are similar (non-inferior).
Data of ATLAS 2M study at 252 weeks, presented at CROI 2022, shows that efficacy, safety and tolerability were similar between monthly and two-monthly dosing of injectable Cabotegravir and Rilpivirine.
Viral load suppression is an important indicator if antiretroviral therapy is having the desired impact for people with HIV. Virological failure occurs when antiretroviral therapy fails to suppress and sustain a person's viral load to less than 200 copies/mL. Virological failure rate was 1-1.5% when long-acting injectable medicines were used, and 95% of drug-related adverse events were mild to moderate. Common side effects reported were headache, fever, and/or injection-site reactions. However, two per cent of the participants withdrew due to adverse events. 98% of the participants preferred long-acting injectable medicines over their earlier daily oral antiviral medicines. Also, 90% participants in the ATLAS 2M study preferred the two-monthly over the monthly injections.
In the FLAIR study, participants were given the option to either first start with oral formulations of the drugs Cabotegravir and Rilpivirine and then switch to their injectable form later, or start directly with the injectables. There was no difference found in the end result for both groups in terms of efficacy or pharmacokinetics (defined as the study of the time course of drug absorption, distribution, metabolism, and excretion).
Based on the positive results of the above-mentioned studies, the regimen of long-acting injectable antiretroviral medicines (Cabotegravir and Rilpivirine) has already been licensed for use in the European Union, USA and Canada as a four-weekly or eight-weekly treatment with or without the initial oral lead-in.
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