Maraviroc offers bos results and viral suppression for more than 96 weeks
Treatment with Maraviroc (Celsentri) is associated with Viral suppression of durable HIV and a favorable lipid profile, according to researchers in the medical treatment of HIV. The randomized study of 96 weeks comparing the safety and efficacy of Maraviroc-based antiretroviral regimens to those containing a ritonavir-driven protease inhibitor.
Two years after randomization, 90% of people in both treatment arms had an undetectable viral load (viral suppression) and increases in CD4 cell count were also comparable. People treated with Maraviroc had significant reductions in total cholesterol and triglycerides.
Excellent viral suppression and optimum lipid profile are achieved by maraviroc
"Suppression of plasma viremia (viral suppression) to below the quantification level, ie <50 copies / ml, the current limit for most guidelines in high-income settings (note that in Brazil the limit is <40), was similar between both arms of the study, demonstrating the durability of virologic response to MVC [Maraviroc ] in more than 96 weeks, "the authors note." The shift to MVC has been associated with significant lipid benefits that may be important in reducing long-term cardiovascular risk. "
Maraviroc belong to a class of antiretrovirals known as inhibitors of CCR5. It only works for people with R5-tropic virusand individuals should be tested for their presence prior to initiating drug therapy. Forty-eight weeks of the March international study demonstrated that Maraviroc was a safe and effective replacement for a ritonavir-boosted protease inhibitor when used in combination with two nucleoside / nucleotide reverse transcriptase (N [t] ir) inhibitors in people with a virus R5-Tropic.
In the current study, the researchers extended their analysis on the effects of maraviroc for 96 weeks.
The primary endpoint was the proportion of people with a viral load below 50 copies / ml; the non-inferiority of Maraviroc was defined as a difference of 1-2% for the protease inhibitor driven. Secondary outcomes were changes in CD4 cell count, renal function, lipid profile and also quality of life, adherence and adverse events.
To be eligible for recruitment, subjects were required to take a steady-state protease inhibitor-based regimen with viral suppression for at least 24 weeks. Recruitment for the study took place between January of 2012 and February of 2014. The last person completed 96-weeks of follow-up in January of 2016.
The study population consisted of 238 individuals - 82 randomized to the protease inhibitor group boosted and 156 to the Maraviroc treatment arm.
Intention-to-treat analysis, including randomized individuals, showed that 89% of the protease inhibitor group boosted and 90,4% of the Maraviroc group had a viral load below 50 copies / ml at week 96, showing the non-inferiority of Maraviroc.
Similar proportions of people - 13% and 17% in the protease inhibitor boosted and in the Maraviroc group, respectively - changed the therapy during follow-up.
Adherence was measured by patient recall for 7 days and was equally high in both treatment groups at week 96, with 91% of people in the protease inhibitor group boosted and 93% of the persons in the Maraviroc arm reporting to take all doses .
"Although there was a unit for once-daily dosing of antiretroviral therapy, the dosage of twice-daily MVC done does not appear to be associated with a cost of adherence," note the researchers.
Increases in CD4 cell counts were comparable for the two groups, with an average gain in the 96 week of 40 cells / mm3.
Renal function - measured by glomerular filtration rate - decreased 4,31 ml / min and 6,53 m / min, the protease inhibitor boosted and Maraviroc groups, respectively, the difference was not significant.
There was no difference in quality of life between regimens.
Therapy with Maraviroc was associated with a significantly better lipid profile over 96 weeks compared to a protease inhibitor boosted in terms of total cholesterol (p = 0.0229) and triglycerides (p <0,001).
At least one adverse event was reported by 87% of people taking Maraviroc and 79% of people taking a protease inhibitor-driven regimen. Most of these events were mild and about 90% for each treatment group were not related to the study drug.
Drug-resistant virus was detected in five people at the end of follow-up, three of whom were taking Maraviroc.
The researchers conclude that the results show that switching from a protease inhibitor boosted to Maraviroc therapy is associated with "durable virologic suppression, favorable metabolic changes and good tolerability during 96 weeks."
Translated by Claudio Souza's originalMaraviroc matches boosted protease inhibitor treatment over 96 weeks, written by Michael Carter and revised Mara T de Macedo
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