A new once-a-day pill which combines four HIV drugs into a single treatment has been found safe and effective, a new study has claimed, raising hopes of millions affected by the deadly virus worldwide.
Clinical trials showed that the new “Quad” pill was fast in acting and has fewer side-effects compared to two widely- used drug regimens.
HIV sufferers have to rigidly adhere to their 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, the 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.
“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,” lead study author Paul Sax from Brigham and Women`s Hospital, Harvard Medical School, was quoted as saying by the Daily Mail.
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 the new 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 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 48th week, about 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.
In May, the FDA`s Antiviral Drugs Advisory Committee voted 13 to one to approve the Quad pill for the treatment of HIV-1 infection in US adults who have yet to receive treatment. They will make a final decision in August.
If approved by regulatory agencies, it would be the first once-daily single-tablet regimen containing an HIV integrase inhibitor.
PTI