Post-weaning gastroenteritis and mortality in HIV-uninfected infants receiving antiretroviral prophylaxis

Polly Clayden, HIV I-Base

G Kafulafula and coworkers assessed gastroenteritis frequency and mortality pre- and post-weaning in infants enrolled in the PEPI trial, an ongoing ART prophylaxis trial in Malawi. [4]

PEPI randomises infants who are HIV-negative at birth to one of three ART regimens. Mothers exclusively breastfeed and then stop all breastfeeding at 6 months. Infants are seen at 1, 3, 6, 9, and 14 weeks and 6, 9, 12, 15, 18, and 24 months. Information on breastfeeding, gastroenteritis, hospitalisation, and mortality was collected at all visits. Infants are tested for HIV. This analysis evaluated age-specific gastroenteritis frequency to age 12 months among infants HIV-negative at the visit in which gastroenteritis was reported and compared these data to these from an earlier study conducted at the same site (NVAZ) in which early weaning was not recommended (median duration of breastfeeding 782 days).

The investigators found that the median duration of overall breastfeeding in PEPI was 183 days. Among HIV-negative infants, the probability of gastroenteritis was 1.7% (27 of 1571) at 6 to 9 weeks, 2.6% (29 of 1096) at 3 months, 7.1% (63 of 893) at 6 months, 13.1% (77 of 590) at 9 months, and 9.0% (34 of 379) at 12 months (all ART arms and breastfeeding modes combined).

The frequency of at least 1 hospitalisation with gastroenteritis was 2.4% (21/ 893) between ages 3 and 6 months and 3.1% (18/590) between 6 and 9 months. The cumulative overall and gastroenteritis-related mortality among the HIV-negative infants in the PEPI and NVAZ studies is shown in the table. Log-rank test significance for overall mortality was p=0.04 and for gastroenteritis-related mortality was p=0.0003.

The investigators found that gastroenteritis frequency in PEPI was highest immediately following weaning. Gastroenteritis-related mortality was higher in PEPI than in NVAZ. They wrote: “Counseling strategies to assist mothers in safe preparation of nutritional weaning foods in resource-limited settings are urgently needed.”

Table 1: Post-weaning gastroenteritis and mortality in HIV-uninfected infants receiving antiretroviral prophylaxis

1 week 8 weeks 3 months 6 months 9 months 12 months
Overall 4/1000 19/1000 22/1000 37/1000 64/1000 81/1000
Gastroenteritis related 0/1000 3/1000 4/1000 6/1000 23/1000 28/1000
Overall 5/1000 17/1000 26/1000 40/1000 54/1000 66/1000
Gastroenteritis related 0/1000 1/1000 1/1000 3/1000 7/1000 12/1000


  1. Kafulafula G, Thigpen M, Hoover D et al. Post-weaning gastroenteritis and mortality in HIV-uninfected African infants receiving antiretroviral prophylaxis to prevent MTCT of HIV-1. 14th CROI, 25-28 February 2007, Los Angeles. Abstract 773.

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