A Phase I Randomized, Controlled Trial of Valganciclovir in Idiopathic Pulmonary Fibrosis

Link to article at PubMed

Ann Am Thorac Soc. 2021 Mar 19. doi: 10.1513/AnnalsATS.202102-108OC. Online ahead of print.


RATIONALE: Human herpesviruses Epstein-Barr Virus (EBV) and cytomegalovirus (CMV) are frequently detectable in the lungs of idiopathic pulmonary fibrosis (IPF) patients and could contribute to disease pathogenesis.

OBJECTIVES: With the goal of inhibiting herpesvirus replication, we tested the safety and tolerability of adding valganciclovir to standard IPF therapy (pirfenidone).

METHODS: We performed a single-center, phase I, double-blind, randomized placebo-controlled trial comparing valganciclovir 900 mg daily to placebo in IPF patients with serologic evidence of prior EBV and/or CMV infection who were tolerating full-dose pirfenidone (2403 mg/day). Subjects were randomized to valganciclovir or placebo 2:1 for 12 weeks of active treatment with off-treatment follow-up for up to 12 months. The primary safety endpoint was the number of subjects discontinuing study drug before completing 12 weeks of treatment.

MEASUREMENTS AND MAIN RESULTS: Thirty-one subjects with IPF were randomized to valganciclovir (n=20) or placebo (n=11). All subjects completed assigned therapy except one subject in the valganciclovir group who discontinued the study drug after developing a rash. Total adverse events were similar between study groups. In prespecified analyses of secondary physiologic endpoints, we observed a trend towards improved forced vital capacity (FVC) from randomization to week 12 in valganciclovir-treated subjects (-10 ml [interquartile range -65, 70 ml]) versus placebo-treated subjects (40 ml [IQR -130, 60 ml]), which persisted through 12 months of follow-up.

CONCLUSION: Valganciclovir is safe and well-tolerated as add-on therapy to pirfenidone in IPF patients. Clinical trial registered with ClinicalTrials.gov (NCT02871401).

PMID:33740394 | DOI:10.1513/AnnalsATS.202102-108OC

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