Efficacy and safety of 2-drug regime dolutegravir/lamivudine in pregnancy and breastfeeding – clinical implications and perspectives

Irena Rohr; Maria Hoeltzenbein; Katharina Weizsäcker; Christoph Weber; Cornelia Feiterna-Sperling; Charlotte K. Metz

doi:10.1515/jpm-2024-0304

Article

Efficacy and safety of 2-drug regime dolutegravir/lamivudine in pregnancy and breastfeeding – clinical implications and perspectives

Irena Rohr , Maria Hoeltzenbein , Katharina Weizsäcker , Christoph Weber , Cornelia Feiterna-Sperling and Charlotte K. Metz

Published/Copyright: September 19, 2024

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From the journal Journal of Perinatal Medicine Volume 52 Issue 9

Abstract

Objectives

To assess the efficacy and safety of a two-drug regimen (2DR) with dolutegravir (DTG) and lamivudine (3TC) in maintaining viral suppression during pregnancy and breastfeeding, and to evaluate its potential as an alternative to the recommended three-drug regimen (3DR) in preventing mother-to-child transmission (MTCT) of HIV.

Methods

We present a case of a 34-year-old pregnant woman who, after discontinuing 3DR due to side effects and poor adherence, was switched to DTG/3TC at gestational week 23. Maternal viral load (VL) and infant HIV status were monitored throughout pregnancy and a ten-month breastfeeding period. Data on pharmacokinetic changes in pregnancy and the risks associated with 2DR were reviewed.

Results

The patient’s VL remained suppressed (<20 copies/mL) from gestational week 23 until the end of the breastfeeding period. A healthy HIV-negative baby was born at 39 weeks, and the child remained HIV-negative after ten months of breastfeeding. The 2DR was well-tolerated, improved adherence, and reduced fetal drug exposure. Despite limited experience with 2DR in pregnancy, no viral rebound occurred, and no adverse effects were observed.

Conclusions

Although 3DR remains the preferred therapy during pregnancy and breastfeeding, this case indicates that DTG/3TC may be an effective alternative for patients experiencing intolerance or poor adherence to 3DR. Further studies are needed to explore the impact of pharmacokinetic changes in pregnancy on 2DR efficacy and to confirm its safety and role in preventing MTCT.

Keywords: HIV; pregnancy; dual therapy; antiretroviral therapy (ART); breastfeeding

Corresponding author: Dr. Irena Rohr, Dr. med., Department for Obstetrics, Corporate Member of Freie Universität Berlin and Humboldt – Universität zu Berlin, Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany, E-mail: irena.rohr@charite.de

Acknowledgments

We sincerely thank the patient for her participation and willingness to share her case for this study. Her cooperation and trust made this work possible.

Research ethics: Ethical approval was not required for this study, as it involved a single patient case report and a literature review. All efforts were made to maintain patient confidentiality and privacy in accordance with the Helsinki Declaration.
Informed consent: Informed consent was obtained from the patient for participation in the study and for the publication of relevant anonymized clinical data.
Author contributions: Irena Rohr conceived and designed the study. Irena Rohr, Charlotte Metz, Katharina Weizsäcker, Christoph Weber and Cornelia Feiterna-Sperling collected the data and performed the analysis. Charlotte Metz drafted the manuscript. All authors contributed to the interpretation of data and critically revised the manuscript for intellectual content. All authors approved the final version of the manuscript for submission.
Use of Large Language Models, AI and Machine Learning Tools: No AI or machine learning tools were used in the analysis of data or drawing conclusions for the study.
Conflict of interest: The authors state no conflicts of interest.
Research funding: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Data availability: The data supporting the findings of this study are available upon reasonable request from the corresponding author. Data are not publicly available due to privacy.

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Received: 2024-07-10

Accepted: 2024-08-21

Published Online: 2024-09-19

Published in Print: 2024-11-26

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Keywords for this article

HIV; pregnancy; dual therapy; antiretroviral therapy (ART); breastfeeding