In recent years, HIV has become a treatable, albeit chronic, disease that was once considered an imminent death sentence. Patients with well-treated HIV can now lead long and largely normal lives if they have perseverance. The effort it took to keep the virus in a daily cocktail of pills was significant. That could change, however: two new treatments show promise in the fight against HIV: one that will replace these pills and one that may ultimately prevent disease.
A shot in the arm for HIV patients
The FDA recently approved Cabenuva, the first injectable, extended-release HIV treatment. Cabenuva was developed by ViiV Healthcare and is given once a month. It is intended as a long-acting replacement for the current regimen for patients whose HIV is already well controlled.
Before starting treatment with Cabenuva, the patients tested the effects of the components in pill form. One of the main components of Cabenuva, cabotegravir, was also approved under the name Vocabria. The other, rilpivirine, is already available under the brand name Edurant. After a month of taking the pills, doctors evaluate how well the patients tolerate them and then decide whether to continue with the prolonged-release tablets.
John Farley, MD, MPH, director of the Infectious Disease Office at the FDA Center for Drug Evaluation and Research, discussed the potential of this drug in a press release. “Currently, the standard of care for HIV patients includes patients taking pills daily to adequately manage their condition. This approval will allow some patients to receive injections once a month instead of daily oral treatment. “
Cabenuva is approved after two clinical studies targeting virologically suppressed HIV patients. The study was tested on more than 1,100 people in 16 countries and lasted 48 weeks. At the end of the study, the patients still showed virological suppression. The most commonly reported reactions included “Injection site reactions, fever (pyrexia), tiredness, headache, musculoskeletal pain, nausea, trouble sleeping, dizziness and rash”. Serious reactions were reported by less than 1% of recipients. These included abdominal cramps and oral numbness changes that occurred within minutes of the injection.
Using antibodies to ward off infection
The NIH recently released the results of the AMP (Antibody-Mediated Prevention) studies, a program run by the National Institute for Allergies and Infectious Diseases (NIAID) that examines the use of antibodies in HIV prevention. The LMP studies included two studies in Brazil, Peru, Switzerland and the USA. These lasted 80 weeks and comprised a total of 4,623 participants. No safety concerns were raised.
The treatment, an injection given every eight weeks, “safely and effectively prevented the acquisition of strains of HIV sensitive to this antibody.” They found that the vaccine was 75% effective in preventing these strains. Long-term overall infection rates were unaffected, but NIAID was confident that this represents progress toward broader results.
Anthony S. Fauci, director of NIAID, said the results of the AMP studies demonstrated that an administered antibody can protect people from acquiring susceptible strains of HIV. The findings from the studies, he said in the press release, “lay the foundation for the future development of long-acting antibody-based HIV prevention tools and ultimately a vaccine”.
Take them home
Cabenuva could transform the lives of 1.2 million Americans living with HIV and offer much less stressful treatment plans than existing options. The NIH antibody study could pave the way for vaccination and potentially prevent that number from growing from 1.2 million.
Sean Marsala is a Philadelphia, Pennsylvania-based health journalist. He loves technology, usually reads, surfs the internet, and explores virtual worlds.