A combination of two injectable antiretroviral long-acting cabotegravir and rilpivirine, given once every 4 or 8 weeks, maintained viral suppression and a standard oral antiretroviral therapy regimen Antiretroviral and appears safe and well tolerated, according to results study LATTE two studies presented inConference on retroviruses and opportunistic infections (just 2016)Taking place this week in Boston, USA.
Medications long action could offer an attractive option for people with HIV who face an antiretroviral treatment of life. These agents have the advantage of being more convenient and potentially increase adhesion, but the disadvantage is that a long-term drug can not be easily removed from the body, and it is particularly important to ensure security in advance.
To this end, the study LATTE (acronym for antiretroviral treatment of long-acting) assessed by ViiV Healthcare and the experimental integrase inhibitor cabotegravir (formerly GSK1265744) andEdurant, rilpivirine, the Janssen, the class of NNRTIs as a simplified process of maintenance schedule with two drug oral dosage for people who had already achieved an undetectable viral load using the standard three Antiretroviral drugs.
Last year, David Margolis justPresenting the findings of a study of 96 weeksAt ViiV, Showing that in 76% of participants who switched to dual oral therapy more rilpivirine cabotegravir viral suppression was also maintained, compared to 63% of people who have joined a three-drug regimen containing efavirenz (Sustiva).
Oral combination was safe and well tolerated, and that's what has laid the foundation to test the injectable version of long-acting drugs with cabotegravir formulation and raltegravir in the study LATTE 2.
Dr Margolis presented the results of thirty-two weeks of the study LATTE in conference 2ª this year.
This phase of analysis (2b) included 309 people with HIV who had not been treated previously (virgins ART). More than 90% were men, about 80% were white and the average age was 35 years. At baseline, the mean cell count was CD4 489 cells / mm3 and almost one fifth had a high viral load> 100.000 copies / ml.
The participants in this open study begins, first, a three-drug induction regimen consisting of a daily application of 30mg cabotegravir more abacavir / lamivudine (drugKivexaorEpzicom).
Those who achieved viral suppression (<50 copies / ml) during the induction period were randomized to receive intramuscular injections of cabotegravir rilpivirine and each 4 weeks (Q4W) or each 8 weeks (Q8W), or stay at the same oral regimen. Previous studies demonstrated that injection cabotegravirRemains at therapeutic levelswith monthly or quarterly dosing regimen with a therapy consisting of intravenous add 2 the 3ml more cabotegravir rilpivirine injections in the buttocks. Dr Margolis suggested that injections in the thigh can make it possible for self-administration. He said that there is some flexibility in dose, so that people can apply injections in a period of a week before or after their scheduled date.
309 of the original participants, 286 achieved viral suppression and were randomized to maintenance therapy. During the maintenance period, 94% of people who received the injection every 4 weeks and 95% of treated every 8 weeks maintained HIV RNA <50 copies / ml in the thirty-second week, the same as 91% of those who they were the oral regimen.
There was a small number of participants - an arm cabotegravir Q4W five Q8W arm and two in the oral therapy arm - not exibiru virologic response. Two of these (one in Q8W and the oral arm) had been defined by the protocol as virological failure, but showed no evidence of resistance to the integrase inhibitor or NNRTI.
Injectable Cabotegravir and rilpivirine were generally safe and well tolerated
Serious adverse events occurred in 6% of people who have changed over injectable study course and 5% of those who were on oral scheme; however, these cases were not considered as they related to the drug.
The most common reactions related to side effects of the drug were at the site of injection, occurring in more than 90% of patients treated with the injection. A universe of 4286 injections, 2282 had reactions such as pain and swelling. These reactions were generally mild or moderate, they usually resolved within a period of one week (average three days) and became less common over time, but they took two people to withdraw from the study.
The most common types of adverse events related to the drug than other injection reactions were fever, fatigue and flu-like illness, experienced by 19 participants in use of injectable drugs and a person in oral scheme. Laboratory abnormalities 3 degree or higher were seen in 16% and 14%, respectively.
The pharmacokinetic analysis showed that the long acting injections maintained the concentrations of cabotegravir levels similar to those observed with oral therapy in the original study LATTE. Concentrations started low and then began to rise, and Dr. Margolis said they are working on strategies to increase the initial concentration levels. Rilpivirine concentrations rose over time, but he said they were well below the level that can present a risk dierto the production of heart problems.
Study participants reported a high level of satisfaction with the treatment - more than 90% of those receiving long-acting injections reported that they were satisfied, compared with about 70% of those on the oral regimen.
Neither the four regime or the eight-week regimen was clearly better. The follow-up study LATTE 2 continue for another ninety-six weeks and researchers have a plan to evaluate dosages of even longer duration in a phase injection schemes with longer durations in three trials.
The long-acting formulations of rilpivirine cabotegravir are also being studied for pre-exposure prophylaxis (PrEP) - the data are also to be presented later this week.
Translated by Cláudio Santos de Souza from the originalCROI 2016: Long-Acting Injectable Cabotegravir + rilpivirine Works Well HIV Maintenance Therapyon February 24 2016
THE Margolis et al.Cabotegravir + rilpivirine the long-acting maintenance therapy: LATTE-week 2 32 result. 2016 Conference on Retroviruses and Opportunistic Infections (CROI), Boston, abstract 31LB, 2016.
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