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Ottawa scientists explore the use of long-acting cabotegravir + rilpivirine in pregnancy
CATIE News
September 22, 2026
- Long-acting HIV treatment with cabotegravir + rilpivirine is an option for some people
- International guidelines do not recommend its use during pregnancy due to efficacy concerns
- Researchers found promising results in pregnancy when oral therapy alone was not an option
Long-acting formulations of cabotegravir + rilpivirine—a combination sold as Cabenuva in Canada and several other high-income countries—have proven effective in the treatment of people with HIV. These long-acting formulations are injected deep into the buttocks every two months. Cabenuva is generally well tolerated, though some people report temporary discomfort and pain at the injection site.
According to a team of scientists at the Ottawa Hospital, leading international guidelines generally recommend the use of Cabenuva but do not recommend its use during pregnancy or in people who are trying to become pregnant. This is because during the later stages of pregnancy, physiological changes may reduce the concentration of cabotegravir + rilpivirine in the blood. In theory, this could reduce the effectiveness of treatment for the parent and potentially increase the risk of HIV transmission to the fetus.
To avoid this potential issue, some doctors switch pregnant patients from Cabenuva to oral HIV treatment during pregnancy. After giving birth, they can switch back to Cabenuva. However, switching between treatments is not ideal.
In Ottawa
Scientists at the Ottawa Hospital noted that the use of Cabenuva could be helpful during pregnancy in people with HIV. For instance, pregnancy-related nausea can make it difficult to take medicines orally, which would make adherence challenging.
The scientists recently described their experience with the first seven women with HIV who received Cabenuva during pregnancy at their clinic.
The first woman was taking Cabenuva when she became pregnant. Her HIV had been well managed for 11 years with oral HIV treatment (antiretroviral therapy, ART). After extensive discussion with the woman and her partner, her medical care team decided to discontinue Cabenuva at week 16 of pregnancy. She was immediately switched to a daily pill sold as Biktarvy that contains bictegravir + TAF (tenofovir alafenamide) + FTC (emtricitabine). She subsequently had what her medical team described as “an uncomplicated delivery of a healthy infant.”
Two other women who started taking Cabenuva before they were known to be pregnant were treated in a similar way after finding out that they were pregnant.
However, the team of scientists noticed that there were challenges with “interrupting and reinitiating [Cabenuva].” As more information became available from other research centres about the levels of long-acting cabotegravir and rilpivirine during pregnancy, the Ottawa medical team decided to take a different approach.
In three other pregnant women, Cabenuva continued to be administered every two months (as normal) throughout pregnancy and after they gave birth. However, during the final four to six weeks of pregnancy, doctors also prescribed a pill of daily Biktarvy to ensure that HIV would be kept under control.
In another woman who was taking Cabenuva when she became pregnant, doctors could not prescribe Biktarvy because of her intolerance to taking pills. Instead, to maintain high levels of cabotegravir and rilpivirine in her blood, they started injecting Cabenuva every month in the sixth month of pregnancy.
The team noted that all women had an undetectable level of HIV at the time they gave birth. In two of these women (who were taking Cabenuva every two months plus daily oral Biktarvy), drug concentrations were measured during the third trimester. One woman had lower-than-ideal levels of cabotegravir and rilpivirine in her blood, while the other had levels within the desirable range.
Safety of cabotegravir and rilpivirine
According to the report from the Ottawa team, there were no reported cases of HIV transmission and no birth defects. Larger studies have not found birth defects to be linked to the use of cabotegravir, rilpivirine or Biktarvy. However, continued monitoring is needed for people who take Cabenuva during pregnancy to find strategies to ensure that they can continue to suppress their viral load and give birth to healthy babies.
In the absence of large studies of Cabenuva in pregnant people, the Ottawa team suggests the following approach for Cabenuva during pregnancy:
“In the exceptional circumstance when a woman is unwilling or unable to take oral therapy, [Cabenuva] can be administered monthly starting before the 28th [week of pregnancy] as a means of improving [the concentration of drugs in Cabenuva], or if oral therapy is an option, [Cabenuva] can be continued every two months through pregnancy and oral therapy [supplementary use of a once-daily pill containing a complete regimen] can be prescribed beginning at weeks [34 to 36 of pregnancy].”
This approach, while helpful for clinicians caring for pregnant people with HIV, underscores the need to fund studies of Cabenuva and other long-acting formulations of ART in this population.
—Sean R. Hosein
Resources
Canadian HIV Pregnancy Planning Guidelines
CATIE statement on the use of antiretroviral treatment (ART) to maintain an undetectable viral load as a highly effective strategy to prevent perinatal transmission of HIV
Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States - DHHS
Reassuring findings from Canadian study on bictegravir safety during pregnancy – CATIE News
REFERENCES:
- McGuinty M, Giguère P, Angel JB. Cabotegravir/rilpivirine in pregnancy: early insights from clinical practice. AIDS. 2026; in press.
- Atoyebi S, Bunglawala F, Cottura N, et al. Physiologically based pharmacokinetic modelling of long-acting injectable cabotegravir and rilpivirine in pregnancy. British Journal of Clinical Pharmacology. 2025 Apr;91(4):989-1002.
- Feiterna-Sperling C, Albers E, Rohr I, et al. A case of delayed detection of vertical transmission of HIV-1 due to maternal therapy with long-acting injectable cabotegravir plus rilpivirine. Clinical Infectious Diseases. 2026 Apr 28: ciag290.
- Jasper A, Fourie W, Chetty S. The safety of cabotegravir in pregnancy: a systematic review and meta-analysis. BMC Infectious Diseases. 2025 Nov 12;25(1):1550.
- Sunagawa SW, Floyd CC, Bares SH, et al. Long-acting cabotegravir/rilpivirine for treatment of HIV during pregnancy: A case series. Open Forum Infectious Diseases. 2025 Oct 22;12(11): ofaf649.
- Geretti AM, Boffito M, Bonora S, et al. Optimizing the use of cabotegravir plus rilpivirine long-acting therapy in HIV care: Evidence, implementation, and unanswered questions. Open Forum Infectious Diseases. 2025 Jul 3;12(7):ofaf368.
- Patel P, Ford SL, Baker M, et al. Pregnancy outcomes and pharmacokinetics in pregnant women living with HIV exposed to long-acting cabotegravir and rilpivirine in clinical trials. HIV Medicine. 2023 May;24(5):568-579.
- Short WR, Willame C, Nguyen H, et al. Evaluating birth outcomes following oral rilpivirine use in pregnancy in the United States: Findings from the Antiretroviral Pregnancy Registry. HIV Medicine. 2026 Jan;27(1):33-41.
From Canadian AIDS Treatment Information Exchange (CATIE).
This content was originally published by CATIE, Canada’s source for HIV and hepatitis C information.
Source: CATIE:
https://www.catie.ca/catie-news/ottawa-scientists-explore-the-use-of-long-acting-cabotegravir-rilpivirine-in-pregnancy
For more information visit CATIE's Information Network at www.catie.ca
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