As HIV has become a chronic disease, and people now are living for a long time with the disease, we know that new medicines will always be needed.
The U.S. Food and Drug Administration approved Viiv Healthcare’s HIV-1 integrase inhibitor, dolutegravir, the first once-daily pill that does not need to be taken in combination with a boosting drug. The hope is that the drug regimen will improve patient compliance, especially among pediatric patients, over drugs that must be taken twice a day, such as Merck’s Isentress.
“HIV treatment should not be a ‘one-size fits all’ paradigm,” says John Pottage, chief medical officer, Viiv Healthcare.
The new drug is the first product to be commercialized by the company, a joint venture of GlaxoSmithKline, Pfizer, and Shionogi dedicated to the development of HIV therapies. It works by preventing the HIV virus from inserting its own genetic material into the DNA of a patient’s infected cell.
Marketed as Tivicay, the FDA approval covers the integrase inhibitor’s use in a combination therapy with reverse transcriptase inhibitors in adults and children over 12 years of age. The drug is expected to hit shelves in the next few weeks.
Regulatory approval was based on four, late-stage clinical trials that treated 2,557 HIV-infected adults and one pediatric safety trial, with main comparators either Atripla, a pill that combines Gilead Sciences’ and Merck’s three different reverse transcriptase inhibitors, or Merck’s Isentress, the first integrase inhibitor to receive FDA approval in 2007.
Two adult trials were conducted in patients that had not previously been treated with any HIV therapies. In each case, Tivicay was given in combination with two additional reverse transcriptase inhibitor drugs. The results of those trials either met established non-inferiority criteria with similar tolerability and adverse side effects, or showed statistically significant improvements in HIV viral suppression with reduced adverse events when compared to their comparators.
A second set of adult trials were conducted in patients previously receiving therapies but either never treated with or resistant to integrase inhibitors. In patients new to integrase inhibitor treatment, 79 percent of patients on the regimen containing Tivicay were virologically suppressed versus 70 percent of patients on the regimen containing Merck’s twice-daily Isentress, a statistically significant difference.
In the most difficult-to-treat patient population, those currently on medication but with resistance to multiple classes of HIV medicines including the integrase inhibitors Isentress and elvitegravir (a component of Stribald), Tivicay had mixed results.
“As HIV has become a chronic disease, and people now are living for a long time with the disease, we know that new medicines will always be needed,” says Pottage.
August 13, 2013