Mode
Text Size
Log in / Sign up

Tenofovir Disoproxil Fumarate in Maternal ART Linked to Modest Creatinine Decline in HIV-Positive WomenWomen on TDF-based HIV meds showed kidney changes compared to infant-only treatment

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Interpret the modest CrCl decline with TDF-ART as likely clinically insignificant, but monitor renal function in postpartum women.

This randomized trial, published as a brief report, compared tenofovir disoproxil fumarate (TDF)-containing maternal antiretroviral therapy (ART) with infant nevirapine prophylaxis (iNVP) in 2431 women living with HIV and CD4 counts ≥350 cells per cubic millimeter. The study was conducted at 14 sites in India and Africa. Women were randomized to receive either TDF-containing ART or iNVP, with follow-up at weeks 1, 6, 26, and 74. The primary outcome was change in creatinine clearance (CrCl) from entry through week 74. Secondary outcomes included changes in calcium and phosphate levels.

For the primary outcome, the mean change in CrCl from entry was larger for TDF-ART compared with iNVP. At week 6, the difference was -11.4 mL/min (95% CI: -14.5 to -8.3). At week 26, the difference was -6.9 mL/min (95% CI: -10.0 to -3.9). At week 74, the difference was -5.1 mL/min (95% CI: -9.4 to -0.9; P = 0.019). These results indicate a statistically significant but modest decline in CrCl associated with TDF-ART.

For secondary outcomes, differences in mean change from entry for calcium and phosphate were close to 0, with narrow confidence intervals that excluded clinically relevant differences. This suggests no significant impact on these electrolytes.

Regarding safety, the study reported that TDF-containing ART had no observed safety concerns for maternal renal function during the postpartum period. However, specific adverse events, serious adverse events, and discontinuation rates were not reported in the available summary.

Compared to prior studies, this trial adds data on renal effects of TDF in a large cohort of postpartum women with HIV. Previous research has shown TDF can cause renal tubular dysfunction, but the clinical significance of modest CrCl declines remains debated. The study's strengths include its randomized design and large sample size.

Key limitations include the lack of reporting on adverse events, discontinuations, and funding sources. The brief report format may omit important details. Additionally, the study population was limited to women with CD4 counts ≥350 cells/mm³, which may not generalize to those with lower counts. The clinical relevance of a 5.1 mL/min difference at 74 weeks is uncertain, as it may not translate to increased risk of renal failure.

Clinically, these findings suggest that TDF-containing ART in postpartum women with HIV is associated with a small but statistically significant decline in renal function. However, the absence of observed safety concerns indicates that the benefit of preventing HIV transmission likely outweighs the renal risk. Practitioners should monitor renal function in women on TDF, but the modest effect size does not warrant avoiding TDF in this population.

Unanswered questions include the long-term renal outcomes beyond 74 weeks, the impact in women with lower CD4 counts, and whether the decline in CrCl is reversible after TDF discontinuation. Further research is needed to clarify the clinical significance of these findings.

For women living with HIV, the choice of medication can affect more than just viral control. It can also touch on kidney health. A recent study looked at a specific group of women who were taking Tenofovir Disoproxil Fumarate, often called TDF, as part of their treatment. This drug is part of the standard care for HIV. The researchers wanted to know if this specific medication caused changes in kidney function during the time after giving birth. They compared these women to a different group that received only infant treatment with a drug called Nevirapine. This comparison helps understand if the mother's medication was causing the issue or if it was something else entirely.

The study included 2,431 women from 14 sites in India and Africa. These women had HIV and had CD4 counts of at least 350 cells per cubic millimeter. This number measures how well the immune system is fighting the virus. The team tracked the women over a long period, checking their health at weeks 1, 6, 26, and 74. The main thing they measured was creatinine clearance. This is a standard test that tells doctors how well the kidneys are filtering waste from the blood. A lower number means the kidneys are working a bit slower.

The results showed a clear difference between the two groups. Women taking the TDF-based treatment had a larger drop in creatinine clearance compared to the other group. By week 6, the average drop was 11.4 milliliters per minute. By week 74, the drop was 5.1 milliliters per minute. These numbers represent a measurable change in how the kidneys performed. The study found this difference was statistically significant, meaning it was unlikely to happen by random chance. The confidence intervals provided by the researchers supported this finding at the one-year mark.

However, the study also looked at other important minerals in the blood. Calcium and phosphate are vital for strong bones and healthy nerves. The researchers found that the changes in these minerals were close to zero. The data showed no clinically relevant differences between the groups. This is a crucial point because it means the kidney function change did not come with a cost to bone health or mineral balance in this specific context. The safety profile for maternal kidney function during the postpartum period appeared stable regarding these minerals.

It is important to read these results with care. The study was a brief report, which means it offers a snapshot of a specific situation. The women in this study were on a specific regimen that included TDF. The comparator group received infant-only prophylaxis, which is a different scenario than standard maternal care in many places. This means the results apply specifically to this comparison and may not translate directly to every woman on HIV medication. We must not overstate what this single study proves. It highlights a signal that needs further investigation rather than confirming a universal rule.

For patients right now, this study suggests that monitoring kidney function is still important for women on TDF. The drop in creatinine clearance was observed, but the lack of mineral changes is reassuring. Doctors will continue to weigh the benefits of controlling HIV against these potential kidney changes. The goal is to keep the virus suppressed while keeping the body healthy. This research adds to the conversation about how we manage long-term HIV treatment. It reminds us that medicine is complex and requires careful watching over time.

What this means for you:
Women on TDF-based HIV meds showed kidney changes, but calcium and phosphate levels remained stable.

Study Details

Study typeRct
Sample sizen = 1,220
EvidenceLevel 2
PublishedMay 2026
View Original Abstract ↓
BACKGROUND: Tenofovir disoproxil fumarate (TDF) is frequently used in antiretroviral therapy (ART) for pregnant and breastfeeding women living with HIV. Although TDF-containing ART is known to be effective for prevention of perinatal transmission, there is limited information about renal safety of maternal TDF during the breastfeeding period. SETTING: In the postpartum component of the PROMISE (Promoting Maternal and Infant Survival Everywhere) trial, 2431 women living with HIV and CD4 counts ≥350 cells per cubic millimeter were randomized to either TDF-containing maternal ART (TDF-ART; n = 1220) or infant nevirapine prophylaxis (iNVP; n = 1211) for the prevention of HIV transmission through breastmilk at 14 sites in India and Africa; 400 women had additional renal evaluations in the P1084s substudy. METHODS: Calculated creatinine clearance (CrCl), calcium (P1084s only), and phosphate (P1084s only) were evaluated at postpartum weeks 1 (entry), 6, 26, and 74. Two-sided Student t tests compared change in CrCl from entry with week 74 (primary). RESULTS: Mean change in CrCl from entry was larger for TDF-ART compared with iNVP; differences [95% confidence intervals (CIs): -11.4 mL/min (-14.5 to -8.3) at week 6, -6.9 mL/min (-10.0 to -3.9) at week 26, and -5.1 mL/min (-9.4 to -0.9; P = 0.019) at week 74]. Differences in mean change in calcium and phosphate from entry were close to 0 with narrow CIs that excluded clinically relevant differences. CONCLUSION: Although participants randomized to TDF-ART had larger decreases in CrCl from entry compared with participants randomized to iNVP, differences attenuated overtime and were not clinically significant. TDF-containing ART had no observed safety concerns for maternal renal function during the postpartum period.
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.