Merck Wins Approval for Two HIV Drugs
Merck won FDA approval for two oral drugs designed to treat the most common strain of HIV.
Delstrigo is a once-a-day combination tablet. The FDA approved the drug with a black box warning, because of concerns that it may aggravate hepatitis B infections. Pifeltro is an oral medicine designed to be used in tandem with other anti-retrovirals.
In Delstrigo’s trial, researchers recruited 728 HIV-positive patients who had never taken anti-retrovirals and randomly gave them either Delstrigo or another combination therapy every day. At 48 weeks, Delstrigo had suppressed viral loads in 84 percent of the patients, compared to 81 percent of patients taking the other combination.
For the Pifeltro trial, researchers recruited another 766 HIV-positive patients who had never taken any other anti-retroviral. They, too, were randomly given daily doses of Pifeltro or another anti-retroviral. After 48 weeks, nearly 84 percent of Pifeltro patients were testing negative for HIV, compared to about 80 percent of the patients taking the other treatment.