TOPLINE:

Maternal antiretroviral therapy (ART) that contained tenofovir disoproxil fumarate yielded a statistically significant reduction in calculated creatinine clearance (CrCl) compared with infant nevirapine prophylaxis (iNVP); however, the reduction diminished by 74 weeks and was not clinically meaningful in women with HIV infection.

METHODOLOGY:

• Researchers conducted a randomized trial across seven countries between April 2011 and September 2016 to assess the effects of tenofovir disoproxil fumarate during breastfeeding on women’s renal health.
• A total of 2431 women (median age, 26.6 years; 97% Black African participants) living with HIV infection and CD4 counts ≥ 350 cells/mm³ were randomly assigned to receive either maternal ART containing tenofovir disoproxil fumarate/emtricitabine/lopinavir, boosted with ritonavir (n = 1220), or iNVP (n = 1211).
• CrCl levels were measured in all participants; 400 women were co-enrolled in a substudy in which renal calcium and phosphate levels were measured.
• The primary outcome was the change in calculated CrCl from week 1 (entry) to week 74 in the postpartum component analysis set.
• Secondary and additional outcomes included changes in CrCl from entry to postpartum weeks 6 and 26 as well as changes in CrCl, calcium levels, and phosphate levels from entry to postpartum weeks 6, 26, and 74 for the substudy.

TAKEAWAY:

• The mean change in CrCl from week 1 to week 74 was significantly lower in the maternal ART group than in the iNVP group (difference in mean change in CrCl, -5.1 mL/min; P = .019).
• Participants in the maternal ART group experienced a significantly greater decline in CrCl than those in the iNVP group, from week 1 to week 6 (difference in mean change, -11.4 mL/min; 95% CI, -14.5 to -8.3) and from week 1 to week 26 (difference in mean change, -6.9 mL/min; 95% CI, -10.0 to -3.9).
• In the substudy, participants in the maternal ART group vs the iNVP group experienced a marked decline in CrCl from week 1 to week 6 (difference in mean change, -11.8 mL/min; 95% CI, -18.7 to -4.8), week 26 (difference in mean change, -4.0 mL/min; 95% CI, -11.2 to 3.2), and week 74 (difference in mean change, -1.2 mL/min; 95% CI, -8.9 to 6.5).
• Mean changes in calcium and phosphate levels from entry differed minimally between the groups, with narrow CIs excluding clinically relevant differences.

IN PRACTICE:

“During breastfeeding, the TDF (tenofovir disoproxil fumarate)-containing ART regimen had no observed adverse impact on maternal renal function,” the authors wrote.

“However, continued monitoring to assess the safety of ART during the postpartum period is essential,” they added.

SOURCE:

This study was led by Kristin Baltrusaitis, PhD, Harvard T.H. Chan School of Public Health, Boston. It was published online on December 31, 2025, in the Journal of Acquired Immune Deficiency Syndromes.

LIMITATIONS:

This study enrolled mostly healthy women; therefore, its findings may not be applicable to participants at a higher risk for renal injury. It also omitted the measurement of the urine protein-to-creatinine ratio, a sensitive marker for tenofovir-related proximal tubulopathy. Finally, about 10% of participants were censored before week 74, reducing the availability of long-term follow-up data.

DISCLOSURES:

This study was supported by the National Institute of Allergy and Infectious Diseases, with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health — all components of the National Institutes of Health. One author reported receiving research support from ViiV Healthcare.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.