In bid to improve patient adherence, the U.S. National Institutes of Health is funding and helping run two clinical trials of long-acting injectable HIV candidates being developed by Johnson & Johnson's ($JNJ) Janssen and GlaxoSmithKline ($GSK).
Some people have difficulty complying to a daily pill regimen for HIV prevention and treatment such as that offered by Gilead Sciences' ($GILD) Truvada, the NIH says.
More evidence of the lack of compliance has arrived via a clinical study funded by the Bill & Melinda Gates Foundation and others, which found that a vaginal gel containing Gilead's anti-HIV drug Viread did not protect women in South Africa from the disease because they did not apply the medication consistently.
"A product that is applied around the time of sex may be suitable for some women, but it did not meet the needs of the majority in our study, most of whom were young, single and lived with their parents," said Helen Rees, the lead author of the study, in a statement, according to Bloomberg. "Methods that are easier for women to incorporate into their lives are likely to be more effective."
The findings add urgency to the NIH's effort to promote long-acting injectable HIV treatments.Anthony Fauci
"A safe, long-acting, injectable antiretroviral capable of protecting against HIV acquisition may serve as an attractive and feasible alternative to a daily pill for some individuals at highest risk for HIV infection and could, therefore, be a powerful HIV prevention tool," said Dr. Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases (NIAID), in a statement.
Janssen's candidate is an injectable formulation of its FDA-approved, once-a-day oral medication marketed as Edurant (rilpivirine) for the treatment of HIV. The NIH says the 132-woman, Phase II trial will consist of 88 patients who will receive the long-acting injectable candidate, dubbed rilpivirine LA, and 44 patients who will receive a placebo version of the injection.
Both the treatment and control group will receive oral rilpivirine for four weeks followed by two gluteal intramuscular injections of rilpivirine LA or placebo at 8-week intervals for 10 months. The patients will be followed for 8 months after the final injections.
The trial will be conducted in South Africa, the U.S. and Zimbabwe. It is being sponsored by the Seattle-based nonprofit organization PATH, who will run the trial in collaboration with NIAID and the Bill and Melinda Gates Foundation, according to ClinicalTrials.gov. The global health focused organization signed a deal with Janssen to develop rilpivirine LA in 2013.
NIAID is sponsoring the Phase II trial of GSK's injectable GSK1265744 (cabotegravir) which is being developed to treat and prevent HIV in both oral and injectable forms. The injectable version of the candidate showed promising results on monkeys in a recent study, NIH says.
The Phase II trial of injectable GSK1265744 will be conducted on 176 HIV-free men and women in Brazil, Malawi, South Africa and the United States in collaboration with GSK and HIV medicine specialist ViiV Healthcare. Patients will receive daily oral tablets of the candidate or an oral placebo for four weeks, followed by 6 gluteal intramuscular injections of the candidate (or placebo for those in the control arm) over 6 months.
The participants will be followed for a year following the last injection, NIH says.
NIH expects both trials to conclude in 2017. Neither trial is ready for participant recruitment.
The trials' principal investigator, Dr. Myron Cohen, said in a statement that "in the absence of an effective HIV vaccine, these studies mark an important step in our quest to find the best HIV prevention strategies that have the potential to bring the HIV epidemic to a halt."
Editor's Note: This article has been updated to contain information about the study of Viread.