Injections subcutaneous Pro 140, a monoclonal antibody that blocks the entry of HIV into cells has been well tolerated and maintained an undetectable viral load for more than one year after cessation of anti-retroviral therapy (HAART) in people with viral suppression of according to a study presented at ASM Microbe 2016 last week in Boston.
HIV coreceptor uses two - CCR5 and CXCR4 receptors - CD4 with the cell surface receptor to enter If the cells. PRO 140 is a humanized monoclonal antibody that works by blocking the CCR5, thereby preventing HIV enter cells and begin replicating. About 70% of people with HIV in the US and to 90% of newly diagnosed people have HIV with tropism (attraction) by CCR5 receiver.
Previous studies have shown that a single intravenous injection of PRO 140 dramatically reduced levels of HIV and a weekly subcutaneous injection resulted in a reduction of viral load significantly greater than that of placebo. The results suggest that pro 140 not adversely affect the normal immune functions mediated CCR5.
The PRO 140 antibody was initially developed by Progenics but was acquired by CytoDyn in 2012. Clinical trial data with Pro 140 have not been presented at scientific conferences or medical journals for several years, but CytoDyn has issued numerouspress releasesdemarcating their progress.
Paul Maddon, a scientific adviser at CytoDyn, presented findings from a phase 2B Pro 140 the study as a maintenance therapy for people who had achieved viral suppression on ART pattern combination.
The CD01 study included 39 adult patients HIV positive exclusively with HIV tropistic to CCR5 (according to the tropism analysis of DNA coreceptor), viral load below 40 copies / ml on a stable surface and a T cell HAART scheme CD4 count above 350 cells / mm3. More than 90% were male with a median age of 55 years.
All participants in this open label study switched with a week of overlap, from their regimen of antiretroviral therapy for the weekly application of subcutaneous injections of PRO 350 140mg alone scheme for up to twelve weeks. Those who had viral rebound restarted HAART.
Among patients 28 evaluation cohort long-term treatment, 15 people who maintained viral suppression by twelve weeks were trained to self-administer their injections (Translator's note: It's easy to do, I do it with another medication twice daily)and allowed to continue with maintenance therapy at PRO 140 to an additional increase of 108 weeks in an extension phase. In 87% group were men, 20% were nonwhite, average age was 55, the median average score of CD4 was 586 cells / mm3e they had been diagnosed with HIV for a median of 13 years.
15 these participants are still PRO 10 140 without HAART for more than one year - and in some cases approaching two years. Among those tested with a single test RNA copies of HIV, the viral load was 0,4 media copies / ml.
Of the remaining participants, four had virologic failure (two consecutive measurements> 400 copies / ml) and restarted HAART, while aHe left the study with undetectable viral load in 47 weeks.
Participants had no drug resistance evidence, those with virologic failure did not experience a change in tropism HIV in patients - allowed the virus entry using CXCR4 receptors instead of CCR5 coreceptor - and no one has developed antibodies against the antibody PRO 140. All participants who restarted HAART recovered full viral suppression.
PRO 140 was generally safe and well tolerated. While overall adverse events were common (more than 90% in the extension phase) were not drug-related or serious adverse events or abandonment of treatment for this reason. All adverse events related to medication were local reactions at injection, usually mild or moderate.
"For [more than] one year subcutaneous weekly application of PRO 140 350mg from full viral suppression, was well tolerated and allowed the potential for evasion toxicity of ART, preserving drug options," the researchers concluded. "These results support further development of Pro 140 SC as a simple, single agent terápico maintenance, with long term "one of a kind" after the first antiretroviral therapy in HIV-1 selected patients. "
They noted that the extension phase of the study in progress, with a plan to further extend the monotherapy PRO 140 beyond 120 weeks for patients with continued viral suppression.
Published: 28 2016 June
28 / 06 - Published not yet reviewed given the importance of the fact
Is news that follows, gives us greatest hopes about the PRO Antibodies - 140
Lalezari J et al (Maddon P present).PRO 140 SC alone provides long-term and complete virological suppression in patients with HIV. ASM microbe, 2016.
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