(RxWiki News) HIV positive patients take a daily 'cocktail' of antiretroviral drugs that help keep the virus at bay. If they don't take every pill strictly as prescribed, the effectiveness is reduced.
That's why pharmaceutical companies are developing pills that combine several drugs in one daily dose.
If approved by regulatory agencies, a pill nicknamed 'Quad' would be the first of these single-tablet pills to contain an HIV integrase inhibitor.
"Ask your doctor if a single-pill regimen fits your needs."
The study was conducted by Gilead Sciences in collaboration with Harvard Medical School and Katholieke Universiteit Leuven in Belgium. The results announced are part phase 3 clinical trials for an ongoing study to determine safety and efficacy of the pill.
Last month, an FDA panel recommended that Quad be approved for patients who have not taken HIV drugs before. The agency is expected to make a decision by the end of August.
Quad combines the new integrase inhibitor elvitegravir (EVG) with cobicistat (COBI) plus emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC/TDF is part of the recommended treatment for an adult beginning treatment, while EVG/COBI is a variable.
EVG and other integrase inhibitors block HIV from integrating fully into human cells, essentially stopping it from replicating. COBI is the part of the formulation that allows EVG to be integrated into the drug.
There are currently other one-pill-a-day HIV treatments on the market, such as Atripla. But, if approved, Quad would be the first to have an integrase inhibitor like EVG.
Quad's first clinical trial assigned 700 patients in North America to take one of two single pill regimens – either Quad or Atripla, which is currently considered the “gold standard” for single pills.
The group taking Quad had slightly better outcomes in suppressing viral loads – a measurement of how much HIV is in the body – to undetectable levels. Quad had 88 percent of patients at that level, compared to 84 percent for Atripla.
Side effects were similar for both groups. More had mild nausea with Quad, but less likely to have dizziness, abnormal dreams, insomnia or rash.
In the second trial, 708 patients who had not taken anti-HIV drugs before were assigned to either Quad or a two-pill treatment. Ninety percent of the Quad group ended with undetectable viral loads, versus 87 percent in the two pill group.
Almost four percent of the Quad group had to discontinue treatment, compared to over five percent in the two pill group. But more Quad patients had kidney complications compared to other HIV treatments.
The study was published in the June 2012 issue of The Lancet.