HIV sufferers have been given hope of a more efficient treatment, after wide-scale tests on a breakthrough pill.
The new ‘Quad’ pill was found to be faster acting and have fewer side-effects compared to two widely-used drug regimens.
And an extra bonus for those who need to take it, the solitary once-a-day pill removes the need for an array of drugs on a daily basis. Sufferers must rigidly adhere to their HIV medication routine because missed doses can quickly lead to the virus becoming resistant to the medication, making them more vulnerable to a progression of their illness.
But now results from two large international trials, published in The Lancet, revealed that Quad was an ‘important new treatment option’ that could improve compliance with treatment.
The human immunodeficiency virus weakens the ability to fight infections and disease, such as cancer. AIDS marks the final stage when the body can no longer battle life-threatening illnesses.
Paul Sax from Brigham and Women’s Hospital, Harvard Medical School, lead author of the first study, said: ‘Our results provide an additional highly potent, well-tolerated treatment option and highlight the simplicity of treatment resulting from combining several antiretrovirals in a single pill.’
He added that studies have shown single pill treatments improve both adherence and patient satisfaction and help prevent prescription errors, helping reducing the likelihood of treatment failure and drug resistance.
The Quad pill, which is a combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, was created by Gilead Sciences.
In May the FDA’s Antiviral Drugs Advisory Committee voted 13 to 1 to approve it for the treatment of HIV-1 infection in U.S adults who have yet to receive treatment. They will make a final decision in August.
In the Lancet study, the first trial randomly assigned 700 patients from centres across North America to start treatment with two different single tablet regimens – either Quad, or a gold standard regimen approved by the FDA in 2006, known as Atripla.
After 48 weeks of treatment, 88 per cent of patients given Quad suppressed viral loads to undetectable levels compared with 84 per cent in the Atripla group.
Adverse events that led to patients discontinuing treatment were infrequent and similar in both groups. Mild nausea was more common with Quad, but patients were less likely to have dizziness, abnormal dreams and insomnia compared with Atripla.
The second trial included 708 adults who had never received treatment from centres across Australia, Europe, North America and Thailand.
Patients were randomly assigned to receive once-daily Quad or a popular and recommended twice-daily combination of protease inhibiotrsritonavir-boosted atazanavir (ATV/RTV) plus FTC/TDF.
By week 48, 90 per cent of people in Quad had undetectable viral loads compared to 87 per cent of people in the ATV/RTV/FTC/TDF group.
The safety of the two regimens was also similar.
If approved by regulatory agencies, the Quad would be the first once-daily single-tablet regimen containing an HIV integrase inhibitor.