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Phase II trial proves new injectable antiretroviral treatment to be as effective as standard oral therapy.

M2 PHARMA-August 3, 2017-Phase II trial proves new injectable antiretroviral treatment to be as effective as standard oral therapy

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Results from a Phase II clinical trial conducted at 50 centres across the globe have found that an injectable antiretroviral therapy (ART) could be as effective as current oral treatments, the Belvitge Biomedical Research Institute (IDIBELL) said on Thursday.

Of the centres conducting the trial, nine were carried out in Spain, led by Dr Daniel Podzamczer, principal investigator of IDIBELL and chief of the HIV and STD unit of the Infectious Diseases Service of Bellvitge University Hospital (HUB).

The study involved 286 patients with previously suppressed viral loads and investigated the effectiveness of the combination of carbotegravir (a new inegrase inhibitor) and rilpivirine (a no nucleoside) which was injected intramuscularly every four or eight weeks in comparison with the standard maintenance therapy, including the orally-administered drugs carbotegravir and abacavir/lamivudine.

In the group treated every four weeks, 87% of patients maintained viral load suppression after 96 weeks, while 94% maintained it in the arm treated every eight weeks. This was better than those receiving standard oral treatment, which saw 84% maintaining viral load suppression.

The results have been published in the medical journal The Lancet. Centres and research teams participating in the study are already working on developing a new Phase III clinical trial with the aim of proving the results in terms of safety, efficacy and tolerability for both injectable treatments, every four and every eight weeks.

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Publication:M2 Pharma
Date:Aug 3, 2017
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