Background: Haematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients are at high risk for severe influenza and its complications, and may not be adequately protected by vaccination.
Methods: Liver, kidney, or liver-kidney transplant or allogeneic HSCT recipients aged ≥1 year were randomized to oseltamivir (75 mg once daily for those ≥13 years or weight-based dosing for children 1-12 years) or placebo for 12 weeks during periods of local influenza circulation. Patients were assessed for influenza infection via daily diary, every-other-week culture and PCR, and baseline and end-of-treatment serology.
Results: A total of 477 subjects were enrolled (239 oseltamivir and 238 placebo); most were adults (96%) and SOT recipients (81%). In the intent-to-treat population, the frequency of laboratory-confirmed clinical influenza (culture positive and/or >4-fold increase in haemagglutinin antibody inhibition [primary end point]) was similar in the oseltamivir and placebo groups (2.1% [5/237] and 2.9% [7/238]). Incidence of laboratory-confirmed influenza was significantly reduced in the oseltamivir group versus placebo when determined by reverse transcriptase-PCR (1.7% [4/237] versus 8.4% [20/238]; 95% CI 2.8, 11.1) or viral culture (<1% [1/237] versus 3.8% [9/238]; 95% CI 0.7, 6.6), giving protective efficacies of 79.9 and 88.8%, respectively. Serious adverse events (oseltamivir 8% and placebo 10%) and adverse events (oseltamivir 55% and placebo 58%) were reported in both arms with a similar frequency. One illness due to oseltamivir-resistant A/H1N1 virus was detected in each group.
Conclusions: Oseltamivir prophylaxis is generally well-tolerated and may reduce culture- or PCR-confirmed influenza incidence in transplant recipients.
Trial registration: ClinicalTrials.gov NCT00412737.