RESEARCH TRIANGLE PARK – With all our attention focused on the COVID-19 coronavirus, it’s easy to forget that other viral outbreaks have wreaked havoc on the health of many Americans.
The release of positive results around ViiV Healthcare’s new injectable HIV drug, cabotegravir (CAB), serves as a friendly reminder. AIDS is still out there. And medical science continues to make progress in shutting it down, almost four decades after the first cases of the disease appeared in the U.S.
ViiV Healthcare is a global HIV specialty company with U.S. headquarters in Research Triangle Park. It announced that preliminary clinical trial results show cabotegravir to be more effective than the current standard-of-care, emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), in preventing HIV.
The study group included men who have sex with men and transgender women who have sex with men, two groups considered at risk for HIV. Two-thirds of study participants were under 30 years old.
CAB, injected once every two months, proved to be 69% more effective than FTC/TDF tablets administered daily. Safety was similar with the two medications.
Cabotegravir is an investigational therapy to both treat and prevent HIV. It belongs to a group of HIV drugs called integrase inhibitors that block the HIV enzyme integrase. This blocking mechanism prevents the disease from multiplying and can reduce the amount of HIV in the body.
The clinical study was funded by the U.S. National Institute of Allergy and Infectious Diseases – a unit of the National Institutes of Health – and ViiV. It was conducted by the HIV Prevention Trials Network (HPTN), a global clinical trials organization that tests the safety and effectiveness of HIV therapies.
The study, HPTN 083, enrolled approximately 4,600 men and transgender women at research centers in the United States, Argentina, Brazil, Peru, South Africa, Thailand and Vietnam.
Following an initial review, the independent Data Safety Monitoring Board recommended that the trial be stopped early and the data released.
“We are thrilled with the results,” said Kimberly Smith, M.D., ViiV’s head of research and development. “If approved, this long-acting injectable has the potential to be a game-changer for HIV prevention by reducing the frequency of dosing from 365 days to six times per year.”
Myron S. Cohen, M.D. – Yeargan-Bate distinguished professor of medicine, microbiology, immunology and epidemiology at the University of North Carolina at Chapel Hill, was co-principal investigator. “Each year, an estimated 1.7 million people are newly diagnosed with HIV,” he said. “We believe more prevention options are needed, in addition to currently available oral tablets for daily use. If approved, a new injectable agent such as long-acting cabotegravir…could play an important role in reducing HIV transmission and helping to end the HIV epidemic.”
ViiV Healthcare, globally headquartered in Brentford, England, is majority owned by GlaxoSmithKline. Pfizer and Shionogi Limited, a Japanese pharmaceutical company, are shareholders. The company has about 700 employees in 15 countries who work exclusively on HIV medicines and research.
(C) N.C. Biotech Center