May 2, 2011
The FDA announced April 28 that people living with HIV who take the entry inhibitor called Fuzeon (enfuvirtide) may be at higher risk for pneumonia. This news comes from a recently completed study that followed 740 people who took Fuzeon compared to 1,110 who didn't.
When Fuzeon was originally approved, data from the 301 and 302 studies showed that more people on Fuzeon suffered from bacterial and other forms of pneumonia almost 12 times as often as those who didn't take it (6.9% vs. 0.6%). More than half were admitted to the hospital, and three others had died.
However, the people in those studies were also in generally poorer health, which may have skewed the original risk for pneumonia. The FDA subsequently required the manufacturer to do follow-up study. The data from that study shows a 34% higher rate of pneumonia in those who took Fuzeon, although it's not clear that the drug is solely responsible for this higher risk.
The prescribing information has now been changed and suggests that people who take Fuzeon should be closely checked for pneumonia symptoms, especially if they have other conditions that may make pneumonia more likely, such as low CD4s, high baseline viral load, smoking, lung disease or injection drug use.
Roche. Observational cohort study on the incidence of pneumonia in HIV-1 patients treated with Fuzeon.