Introduction: Long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) represents a novel antiretroviral strategy that bypasses gastrointestinal absorption, potentially advantageous in pregnant individuals unable to tolerate oral therapy. However, its use in pregnancy remains off-label due to limited pharmacokinetic (PK), safety and clinical outcome data. Case presentation: We report the case of a 26-year-old woman from Ghana living with HIV-1 (subtype CRF02_AG), with a longstanding history of social vulnerability, poor adherence and multiple treatment interruptions. She presented at gestational week (GW) 20 with an ongoing oral regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), initiated weeks earlier. Despite an initial viral load decline, virological rebound to 57,950 copies/mL was documented at GW 28, attributed to severe hyperemesis gravidarum (HEG) impairing drug intake and absorption. No resistanceassociated mutations were detected. Given the inability to tolerate oral therapy, CAB/RPV LA (600/900 mg) was initiated intramuscularly at GW 29, with a second injection 4 weeks later. Virological suppression (<20 copies/mL) was achieved within 4 weeks of the first injection. At GW 36, an elective caesarean section was performed with intravenous zidovudine prophylaxis and neonatal zidovudine syrup, resulting in the delivery of a neonate who has tested HIV-negative on all assessments to date. No adverse maternal or neonatal outcomes were observed. Discussion: This case highlights HEG as an underrecognised cause of antiretroviral treatment failure mediated by impaired absorption rather than virological resistance, and supports CAB/RPV LA as a viable rescue strategy in this setting. Conclusion: It also underscores the urgent need for prospective pharmacokinetic and safety data in pregnancy.

Long-acting injectable cabotegravir/rilpivirine in a pregnant woman living with HIV with hyperemesis gravidarum:a case report and review of literature / Lattuada, E., Delama, A., Castelli, A., Mori, G., Piacentini, D., Lanzafame, M.. - In: INTERNATIONAL JOURNAL OF STD & AIDS. - ISSN 0956-4624. - 2026:(2026). [10.1177/09564624261461198]

Long-acting injectable cabotegravir/rilpivirine in a pregnant woman living with HIV with hyperemesis gravidarum:a case report and review of literature

Lanzafame, Massimiliano
2026-01-01

Abstract

Introduction: Long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) represents a novel antiretroviral strategy that bypasses gastrointestinal absorption, potentially advantageous in pregnant individuals unable to tolerate oral therapy. However, its use in pregnancy remains off-label due to limited pharmacokinetic (PK), safety and clinical outcome data. Case presentation: We report the case of a 26-year-old woman from Ghana living with HIV-1 (subtype CRF02_AG), with a longstanding history of social vulnerability, poor adherence and multiple treatment interruptions. She presented at gestational week (GW) 20 with an ongoing oral regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), initiated weeks earlier. Despite an initial viral load decline, virological rebound to 57,950 copies/mL was documented at GW 28, attributed to severe hyperemesis gravidarum (HEG) impairing drug intake and absorption. No resistanceassociated mutations were detected. Given the inability to tolerate oral therapy, CAB/RPV LA (600/900 mg) was initiated intramuscularly at GW 29, with a second injection 4 weeks later. Virological suppression (<20 copies/mL) was achieved within 4 weeks of the first injection. At GW 36, an elective caesarean section was performed with intravenous zidovudine prophylaxis and neonatal zidovudine syrup, resulting in the delivery of a neonate who has tested HIV-negative on all assessments to date. No adverse maternal or neonatal outcomes were observed. Discussion: This case highlights HEG as an underrecognised cause of antiretroviral treatment failure mediated by impaired absorption rather than virological resistance, and supports CAB/RPV LA as a viable rescue strategy in this setting. Conclusion: It also underscores the urgent need for prospective pharmacokinetic and safety data in pregnancy.
2026
Lattuada, Emanuela; Delama, Andrea; Castelli, Alessandro; Mori, Giovanni; Piacentini, Daniela; Lanzafame, Massimiliano
Long-acting injectable cabotegravir/rilpivirine in a pregnant woman living with HIV with hyperemesis gravidarum:a case report and review of literature / Lattuada, E., Delama, A., Castelli, A., Mori, G., Piacentini, D., Lanzafame, M.. - In: INTERNATIONAL JOURNAL OF STD & AIDS. - ISSN 0956-4624. - 2026:(2026). [10.1177/09564624261461198]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11572/493793
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