Merck & Co. announced that the Food and Drug Administration has approved not one, but two, medicines for the HIV-1 disease that contain the company’s investigational medicine, doravirine.
The two drugs, named Delstrigo and Pifeltro, were approved to treat adult patients that have not undergone any antiretroviral treatment.
According to Merck, Delstrigo is a once-daily fixed-dose combination tablet of doravirine, lamivudine and tenofovir disoproxil fumarate, while Pifeltro is a new non-nucleoside reverse transcriptase inhibitor which is to be administered in combination with other antiretroviral medicines.
Dr. George Hanna, vice president and therapeutic area head of infectious diseases, Global Clinical Development at Merck Research Laboratories, stated, “As part of Merck’s 30-year commitment to the care of people with HIV, we are pleased to now bring forward these two new antiretroviral treatment options, Delstrigo and Pifeltro, which we believe offer a compelling clinical profile for clinicians and people living with HIV.”
He added, “We are thankful to the researchers as well as those living with HIV and their communities for the collaboration that made today’s approval possible.”
According to a company spokesperson, Delstrigo treatments will cost $70 a day while Pifeltro treatments will cost $46 a day.
“As a result of the remarkable strides made in the fight against HIV, clinicians and their patients have the opportunity to work together to identify treatment regimens that may be best for each individual, taking into account other aspects of that person’s health, including other medicines they may be taking,” said Dr. David Wohl, professor, Division of Infectious Diseases, University of North Carolina (UNC) Chapel Hill School of Medicine.
The “approvals of DELSTRIGO and PIFELTRO provide two new options for the treatment of HIV-1 in appropriate treatment-naïve adult patients,” Wohl further stated.
“Today, with the right access and care, people living with HIV are better able to manage this chronic condition,” said Kathie Hiers, the chief executive officer, AIDS Alabama. “We are thankful for Merck’s unwavering commitment to help address unmet needs through the development of new treatment options, and the provision of community support and educational resources for people living with HIV.”
Merck’s website reads, “In the mid-1980s, Merck began its clinical HIV research in response to what the company perceived as a potential epidemic – our scientists were among the first to discover and develop medicines for the treatment of HIV. Today, a future where HIV/AIDS can be a manageable illness is closer, in part, because of Merck’s response to the crisis.”
“Since the first HIV products became available nearly two decades ago, Merck has worked to expand access to our medicines, build healthcare infrastructure, and address health and development challenges around the world. Merck maintains longstanding efforts to deliver its medicines to those who need it most, including differential pricing, voluntary licensing, public-private partnerships, philanthropic programs, and continued research and development efforts in HIV.”