Background: Retroviral infection has been implicated in the pathogenesis of primary Sjögren's syndrome.
Objective: To examine the efficacy of the reverse transcriptase inhibitor lamivudine in patients with this syndrome.
Methods: 16 patients with primary Sjögren's syndrome were randomised to receive either lamivudine 150 mg twice daily or placebo for three months. Measures of lacrimal and salivary function, including minor salivary gland biopsies, were obtained before and after treatment.
Results: Treatment with lamivudine did not result in significant improvement in the primary outcome measure of unstimulated whole salivary flow or other secondary measures, including minor salivary gland biopsy focus scores.
Conclusion: Lamivudine is not effective in patients with primary Sjögren's syndrome, suggesting either that a retroviral aetiology is not present or that it may be important only in early disease.