The Marketing Authorisation Application for Gilead Sciences Quad single-tablet regimen for the treatment of HIV-1 has been validated by the EMA.

The application is supported by results from two Phase III studies which demonstrated the tablet’s safety and efficacy data and by clinical data for the individual components of the Quad and Chemistry, Manufacturing and Controls (CMC) information.

Norbert Bischofberger, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences, says Gilead is working with the regulator “to bring this new single-tablet regimen to physicians and patients as quickly as possible”.

The regimen contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate and was submitted to the EMA in November 2011. The submission to the FDA was made in October 2011.

Gilead’s first single-table regimen, Atripla, was approved in the EU in 2007. Its second single-tablet regimen, Eviplera – which combines its Truvada and Tibotec Pharmaceutical’s rilpivirine – was approved in the EU in November 2011.

“Based on the safety and efficacy data from the Phase 3 pivotal studies, we believe the Quad single-tablet regimen has the potential to be a convenient treatment option for patients new to HIV therapy,” said Norbert Bischofberger.

Immediate antiretroviral therapy (ART) following diagnosis of HIV-1 infection is more effective than waiting until symptoms appear, according to a new US study published in the Journal of Infectious Diseases.

A multicentre clinical trial found that immediate ART slowed the rate of disease progression without leading to drug resistance.

The study suggests that immediate ART may reduce the patient’s overall need for drug therapy, reducing the long-term cost of treatment.

The AIDS Clinical Trials Group Setpoint Study, conducted at the Medical College of Wisconsin, divided 130 men and non-pregnant women who had contracted HIV within the previous six months into two groups: one receiving ART for 36 weeks and the other with ART deferred.

The investigators found that the immediate treatment group had a better outcome than the deferred group – half of whom required the start of HIV treatment before the study endpoint.

The report commented that “if immediate therapy is not begun, progression to meeting standard criteria for ART initiation may occur more rapidly than expected, especially with changing treatment paradigms.”

They also noted that immediate treatment conferred protection both during ART and for some time afterwards, and that it had little negative effect in terms of toxicity or drug resistance.

Harout Tossonian and Brian Conway of the University of British Columbia, Canada, concluded that “immune preservation and reduction in the latent pool of HIV-1-carrying CD4 T-cells seems to require intervention at the earliest possible time of acute infection.”

They also commented: “The initial course of 36 weeks of treatment may delay the need for re-starting it more than the 36 weeks spent on it from the time of initial presentation. Thus over the lifetime of the patient, there will be less cumulative drug exposure.”