7th International AIDS Society Conference, Kuala Lumpur, June 2013:
A new study combining a once-monthly dose of a nan-oparticle formulation of a new integrase inhibitor called GSK-744 with a once-monthly NNRTI called TMC-278 was largely well tolerated in healthy HIV-negative people over 134 days.
The study is looking at a new combination of antiretroviral (ARV) drugs that may be particularly useful in people who struggle with adherence, who don’t want to take a daily drug, or who want to use the medications for pre-exposure prophylaxis (PrEP). A separate study for those using either drug alone as PrEP is underway. The current study with the combination regimen was to judge safety for use as ARV treatment in people living with HIV.
Four dosing strategies were tested in the study, following a 14-day oral lead-in dose of GSK-744. After the lead-in dose, people received a lead-in sub-cutaneous (subQ) or intramuscular (IM) 800mg dose of GSK-744 followed by one of the following: 1] an IM 200mg dose alone, once monthly for 3 months; 2] a combo dose of 200mg GSK-744 + 900mg TMC-278 IM once monthly for 3 months; 3] a combo dose of 200mg GSK-744 + 900mg TMC-278 subQ for 3 months, or 4] the single large dose of 800mg GSK-744 IM every 3 months.
Levels of the drug in all arms remained above the cut-off of minimal interaction seen with people taking the drugs orally.
There were no serious side effects. The subQ dose resulted in longer-lasting (at least 30 days) nodules of up to 3 centimeters under the skin than the IM dose, but both strategies reported nodules. It is unclear yet what will be the case in terms of side effects and efficacy against HIV over time in those living with the virus.
In all, what this signifies is a potential therapy that might be ideal for people with adherence challenges who are able to keep appointments on a monthly basis.