Biktarvy found effective in treating people whose injectable HIV regimens failed

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CATIE
CATIE News 06192024
  • Long-acting injectable HIV treatment is highly effective, but may not work for everyone
  • Ottawa researchers explored alternatives for five patients whose long-acting treatment failed
  • In all five cases, a switch to an oral Biktarvy regimen effectively suppressed HIV

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HIV treatment (antiretroviral therapy; ART) is highly effective when used as directed. A key goal of ART is to suppress HIV and keep it suppressed. This allows the immune system to largely repair itself. The power of ART is so transformative that researchers increasingly project that many ART users will live well into their senior years.

The following combinations formulated into one pill that can be taken once daily are recommended by U.S. treatment guidelines for the initial treatment for people with HIV: 

  • Biktarvy (bictegravir + TAF + FTC)
  • Dovato (dolutegravir + 3TC)
  • Delstrigo (Dovato + TDF + FTC)

These regimens are highly effective and generally safe.

Another regimen, consisting of two pills once daily, that is also highly effective and recommended is the following:

  • dolutegravir + tenofovir + either 3TC or FTC

Several years ago, the first long-acting injectable formulation consisting of two HIV drugs (cabotegavir + rilpivirine) was approved as a complete treatment for use in people with HIV. This treatment is sold under the brand name Cabenuva in North America and Australia.

In studies and in practice, Cabenuva is highly effective. However, about 1% of people who have used this regimen can develop virological failure (persistently detectable viral load) despite excellent adherence to injections. The reasons for these rare cases of virological failure are not clear.

In Ottawa

A team of researchers and doctors in Ottawa, Ontario, have become leaders in the deployment of injectable long-acting ART. Over the course of two years, in 250 people who used Cabenuva, they found only five cases where virological failure occurred.

A major question in such cases of virological failure is: What subsequent regimen should doctors prescribe?

The Ottawa team reports their findings from five people who developed virological failure while on injectable long-acting ART. They all subsequently switched to Biktarvy (one pill, once daily) and successfully resuppressed their viral load.

Details of cases

The five people were between 24 and 50 years of age. Three were assigned female at birth and two were assigned male at birth. Body mass index (BMI) of the five people ranged between 25 and 37 kg/m2.

Initially participants had asked to use Cabenuva because it was more convenient than daily pill-taking. Prior to initiating injectable ART, none of the participants had HIV that was resistant to cabotegravir or rilpivirine. 

According to the researchers, four of the participants were adherent to their scheduled injections of Cabenuva. 

In the case of the remaining participant, the researchers noted that at one point, after receiving their dose of injectable ART, this person travelled overseas for an extended period where injectable ART was not readily available. To maintain viral suppression, this person took oral cabotegravir + rilpivirine. Upon their return to the Ottawa clinic, injectable ART was reinitiated. However, a few months later, blood tests revealed that their viral load was more than 91,000 copies/mL. Viral loads in the remaining four participants (at the time virological failure was detected) were between 1,280 copies/mL and 9,340 copies/mL.

Blood samples from all five participants revealed that HIV had mutated and was resistant to cabotegravir and rilpivirine. 

Doctors prescribed oral Biktarvy (one pill taken once daily with no food requirements) and all the participants were quickly able to resuppress HIV. Furthermore, they have remained suppressed after being on Biktarvy for nearly one year.

Bear in mind

Biktarvy was highly effective in the treatment of five people whose injectable ART regimen had failed. The Ottawa report is promising, but larger and longer studies are needed so that researchers can be certain about the effectiveness of Biktarvy in people whose injectable ART regimens have failed.

—Sean R. Hosein

REFERENCES:

  1. Giguère P, Agtarap K, McGuinty M, et al. Bictegravir/emtricitabine/tenofovir alafenamide after virologic failure to cabotegravir/rilpivirine. AIDS. 2025; in press. 
  2. Trickey A, Sabin CA, Burkholder G, et al. Life expectancy after 2015 of adults with HIV on long-term antiretroviral therapy in Europe and North America: a collaborative analysis of cohort studies. Lancet HIV. 2023 May;10(5):e295-e307. 
  3. Ring K, Orkin C. Long-acting antiretroviral therapy in the context of viral suppression. Current Opinion in HIV/AIDS. 2025 Jan 1;20(1):4-10.  535.
  4. Serris A, Ferre VM, Le Hingrat Q, et al. Real-world data on long-acting intramuscular maintenance therapy with cabotegravir and rilpivirine mirror Phase 3 results. Journal of Antimicrobial Chemotherapy. 2024 Nov 4;79(11):2932-2938.    
  5. Gutiérrez F, Fernández-González M, Ledesma C, et al. Virological History Predicts Non-Sustained Viral Suppression with Long-Acting Cabotegravir and Rilpivirine Therapy, Independent of Pharmacokinetic Parameters. Clinical Infectious Diseases.  2025 Apr 30;80(4):842-853.