IPF is a lung disease that primarily affects middle-aged and older men. Its hallmark is lung fibrosis — or tissue hardening and scarring — that leads to breathing difficulties. There is no cure for it.
“Patients with IPF often become progressively more disabled by their lung disease, and on average, they have worse survival than patients with metastatic breast or colon cancer,” Dr. Jonathan Kropski, a Vanderbilt medical professor who is the study’s lead investigator, said in a press release.
Researchers have discovered that almost all IPF patients have a herpes virus known as cytomegalovirus that can cause mononucleosis.
Healthy people are frequently exposed to the virus, then carry it throughout their life, with only mild symptoms. But in IPF patients it can aggravate lung injury, Kropski said.
In previous studies, the team discovered that the lung fibrosis of mice can worsen after a herpes infection.
That prompted them to hypothesize that either the virus, or the immune response to it, contributes to lung injury.
The team decided to use Genentech’s antiviral medication Valcyte (valganciclovir) to see if their supposition is correct. Valyte targets human herpes viruses like cytomegalovirus. In fact, doctors commonly treat transplant recipients with it to prevent the reactivation of cytomegalovirus.
“What’s exciting about this is it’s a completely different area from where other IPF trials have focused,” Kropski said. “Most of the current studies and many of the medications previously investigated for treating IPF target the end stage of the disease.”
The Vanderbilt team hopes that focusing on an earlier point in the disease process will lead to treatments that enable the lung to repair itself. “Nothing has been shown to do that so far,” Kropski said.
The pilot study’s first phase will involve whether patients can tolerate the treatment over 12 weeks. The team will compare patients taking Valcyte with those on a placebo.
Researchers said the 30 patients will continue taking the medications they are currently on. The team will check patients’ immune response to the virus, lung function, exercise capacity, and oxygen levels.
If the results are encouraging, they plan to conduct a larger, multicenter Phase 2 trial.