Empirical treatment with valganciclovir in infants living with HIV and hospitalised with severe pneumonia in Africa: a multicentre, open-label, factorial, randomised, controlled, superiority trial.

Empirical valganciclovir in infants aged 28–365 days hospitalized with severe HIV-associated pneumonia is linked to lower day-15 mortality (rate ratio 0·81, 95% CI 0·61–1·08).

• Why it matters: Mortality remains high in severe HIV-associated pneumonia in African infants, and the trial addresses whether empiric treatment targeting cytomegalovirus improves survival beyond standard care.
• What they did: In 19 hospitals across six African countries, 558 infants were randomized in a 2×2 factorial design to standard of care with or without 15 days of oral valganciclovir (16 mg/kg per 12 h), with or without 6 months of tuberculosis treatment.
• The result: At 12 months, death was 43% vs 48% (0·88, 95% CI 0·74–1·05), and a time-varying model showed lower day-15 adjusted hazard (0·60, 95% CI 0·41–0·87); severe adverse events were not more common (odds ratio 0·64, 95% CI 0·35–1·16).

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