Impact of switching to injectables cabotegravir and rilpivirine on sleep disturbances in a cohort of people living with HIV

Abstract

Background

Recently, injectable cabotegravir/rilpivirine (ICAB/RPV) became available for HIV treatment. However, there are no real-life data on the impact of switching to ICAB/RPV on sleep disturbances (SD). Therefore, we aimed at assessing and investigating this aspect in our cohort.

Methods

A SD multidimensional assessment (Epworth Sleepiness scale, Insomnia severity Index, Berlin Questionnaire, and Pittsburg Sleep Quality Index, PSQI) was performed to all people who consented before starting ICAB/RPV and 12 wk after the switch. Demographics, life-style habits, laboratory, and clinical data were collected from medical health records.

Results

To June 2023, 46 people were included, 76.1% males, with a median age of 48.5 (IQR: 41–57), 50% had multimorbidity, 13% was on polypharmacy. Median age with HIV and CD4 + T cell count nadir were 10 (5–19.5) years and 360 (205–500) cell/mm³, respectively. The reason to start a long-acting strategy was person’s choice in all cases. Baseline antiretroviral regimens were mostly: tenofovir alafenamide/emtricitabine/rilpivirine (39.1%) and dolutegravir/lamivudine (32.6%). No significant changes were observed in any of the scores for each questionnaire, but for a worsening PSQI. 37% people reported a subjectively improved sleep quality, even if statistically significant changes were not observed in almost all the sleep parameters.

Conclusions

To the best of our knowledge, this is the first study exploring impact of switching to ICAB/RPV on SD. Despite integrase inhibitor have been associated with SD, we did not observed a negative impact on sleep quality after the switch to ICAB/RPV. More studies and with larger number of people are necessary to confirm our results.

Keywords:

• PLWH
• sleep disturbances
• insomnia
• long acting
• cabotegravir/rilpivirine
• injectables

Acknowledgments

We want to thank all the staff (doctors and nurses) working in the Padua HIV clinic. This study was presented at EACS 2023 as poster presentation (n.290)

Disclosure statement

MM received research grant from Gilead, fees for advisory board from ViiV Healthcare, speaker’s honoraria from Gilead, ViiV Healthcare, MSD; AC, LS, DL received speaker’s honoraria from Gilead, ViiV Healthcare, MSD; all the other authors declare no conflict of interests.

Ethical approval

Participants signed a written informed consent for participation. Local Ethics Committee approved the study protocol (n.2763, 21.10.2021).

Additional information

Funding

This study did not receive any funding and was conducted during routine clinical practice.