Safety and efficacy of HIV hyperimmune globulin for prevention of mother-to-child HIV transmission in HIV-1-infected pregnant women and their infants in Kampala, Uganda (HIVIGLOB/NVP STUDY)
Carolyne Onyango-Makumbi, Saad B Omer, Michael Mubiru, Lawrence H Moulton, Clemensia Nakabiito, Philippa Musoke, Francis Mmiro, Sheryl Zwerski, Hans Wigzell, Lars Falksveden, Britta Wahren, Gretchen Antelman, Mary Glenn Fowler, Laura Guay, J Brooks Jackson, Carolyne Onyango-Makumbi, Saad B Omer, Michael Mubiru, Lawrence H Moulton, Clemensia Nakabiito, Philippa Musoke, Francis Mmiro, Sheryl Zwerski, Hans Wigzell, Lars Falksveden, Britta Wahren, Gretchen Antelman, Mary Glenn Fowler, Laura Guay, J Brooks Jackson
Abstract
Background: This phase III, randomized, clinical trial compared single-dose nevirapine (sdNVP) plus HIV hyperimmune globulin (HIVIGLOB) with sdNVP alone for preventing maternal-to-child transmission of HIV. Primary objectives were to determine rates of HIV infection among infants and to assess the safety of HIVIGLOB in combination with sdNVP in HIV-infected Ugandan pregnant women and their infants.
Methods: Mother-infant pairs were randomized to receive 200 mg of nevirapine to women in labor and 2 mg/kg NVP to newborns within 72 hours after birth (sdNVP arm) or to receive sdNVP plus a single intravenous 240-mL dose of HIVIGLOB given to women at 36- to 38-week gestation and a single intravenous 24-mL dose to newborns within 18 hours of birth (HIVIGLOB/sdNVP arm). Risk of HIV infection was determined using Kaplan-Meier and risk ratio estimates at birth, 2, 6, 14 weeks, 6, and 12 months of age.
Results: Intent-to-treat analysis included 198 HIVIGLOB/sdNVP and 294 sdNVP mother-infant pairs. At 6 months of age, the primary endpoint, there was no statistically significant difference in HIV transmission in the HIVIGLOB/sdNVP arm vs. the sdNVP arm [18.7% vs. 15.0%; risk ratio = 1.240 (95% confidence interval: 0.833 to 1.846); P = 0.290]. Similarly, the proportion of serious adverse events in the HIVIGLOB/sdNVP and sdNVP arms, respectively, for mothers (18.9% vs. 19.3%; P = 0.91) and infants (62.6% vs. 59.5%; P = 0.51) was not significantly different.
Conclusions: Giving mother-infant pairs an infusion of peripartum HIV hyperimmune globulin in addition to sdNVP for preventing maternal-to-child transmission was as safe as sdNVP alone but was no more effective than sdNVP alone in preventing HIV transmission.
Trial registration: ClinicalTrials.gov NCT00639938.
Conflict of interest statement
CONFLICT OF INTEREST STATEMENT J. Brooks Jackson as Principal Investigator for the trial has full access to all the data and has final responsibility for the decision to submit for publication. None of the authors have any conflicts of interest related to the conduct or reporting of this study.
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Source: PubMed