ViiV files patient-friendly monthly HIV injection in US

ViiV Healthcare has submitted its once-monthly two-drug injected treatment for HIV to the US Food and Drug Administration (FDA).

The specialist HIV company, which is majority owned by GlaxoSmithKline, hopes its New Drug Application (NDA) will be approved, which would mean greater convenience for patients who routinely take tablets daily for the disease.

The treatment is an investigational injectable combination of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.

The NDA follows two phase 3 studies, which demonstrated the combination of cabotegravir and rilpivirine, injected monthly, was as effective as a standard of care, daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period. These results were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “The long-acting, once-monthly, injectable regimen of cabotegravir and rilpivirine has the potential to give people living with HIV one month between doses with similar safety and efficacy as today’s standard of care – an oral three-drug regimen that has to be taken every day.

“ViiV Healthcare is proud to be at the forefront of this innovation in HIV treatment and we look forward to working with the FDA to provide people living with HIV in the US this novel option.”

Cabotegravir is an investigational integrase inhibitor (INI) that is being developed by ViiV to treat and prevent HIV. It is not currently approved by any regulatory bodies.

Johnson & Johnson’s pharmaceutical arm, Janssen Sciences, developed Edurant (rilpivirine), a daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used to treat HIV-1 infection in combination with other antiretroviral agents in certain patients. It is unapproved to date.

Earlier this month, Viiv Healthcare’s Dovato, a once-a-day, single-tablet combination of dolutegravir (DTG) and lamivudine (3TC) for adults with HIV-1 who had not received treatment before, was approved by the FDA.

Meanwhile, a phase 2 trial by Taiwan’s United BioPharma and one of the US government-funded National Institutes of Health, showed that a new antibody UB-421 was safe and did not induce production of antibody resistant HIV. It suppressed the virus for up to four months after patients stopped taking antiretroviral medicines.

It works by blocking the HIV binding sites on an unchanging human protein that HIV uses to infect T-cells. Further studies of UB-421 are underway.