Subcutaneous injections of Pro 140, a monoclonal antibody that blocks the entry of HIV into cells, was well tolerated and maintained viral load undetectable for more than one year after discontinuation of antiretroviral therapy (ART) in people with viral suppression According to a study presented in the ASM Microbe 2016 last week in Boston.
HIV uses two coreceptors - CCR5 and the CXCR4 receptors - along with the CD4 cell surface receptor to be inserted into cells. PRO 140 is a humanized monoclonal antibody that works by blocking CCR5, thereby preventing HIV from entering cells and starting to replicate. About 70% of people with HIV in the US and up to 90% of newly diagnosed people, have HIV with tropism (attraction) by the CCR5 receptor.
Previous studies have shown that a single intravenous injection of PRO 140 dramatically reduced HIV levels and a weekly subcutaneous injection resulted in a significantly higher viral load reduction than placebo. The results suggest that pro 140 does not negatively affect the normal immune functions mediated by CCR5.
PRO 140 antibody was first developed by Progenics but was acquired by CytoDyn in 2012. Data from clinical trials with Pro 140 have not been submitted to scientific conferences or medical journals for several years, but CytoDyn has issued numerous press releases demarcating your progress.
Paulo Maddon, a scientific advisor at CytoDyn, presented findings from an 2B phase of the 140 Pro study as maintenance therapy for people who had achieved viral suppression in standard combination ART.
The CD01 study included 39 HIV-positive adult patients exclusively with tropic HIV to CCR5 (according to Coreceptor DNA tropism analysis), viral load below 40 copies / ml on a stable surface and a T-cell ART regimen CD4 counts up 350 cells / mm3. Over 90% were men with a median age of 55 years.
All participants in this open study switched over a week of overlap from their ART regimen to the weekly application of subcutaneous injections of 350mg from PRO 140 in a monotherapy regimen for up to twelve weeks. Those who had viral rebound restarted ART.
Among the 28 patients in the long-term treatment cohort, 15 people who maintained viral suppression for 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 proceed with maintenance therapy by PRO 140 for an additional increment of 108 weeks in an extension phase. In this group 87% were men, 20% were non-white, the mean age was 55, the median CD4 count was 586 cells / mm3 and they had been diagnosed with HIV for an average of 13 years ago.
Of these 15 participants, 10 are still in PRO 140 without ART for more than one year - and in some cases approaching two years. Among those tested with a single copy of HIV RNA assay, the lowest viral load average was 0,4 copies / ml.
Of the remaining participants, four had virologic failure (two consecutive measurements of> 400 copies / ml) and restarted ART, while a left the study with undetectable viral load in 47 weeks.
Participants did not present evidence of drug resistance, those with virologic failure did not experience a change in HIV tropism in patients who - allowed entry of the virus using the CXCR4 receptors instead of the CCR5 coreceptors - and no one developed antibodies to the antibody PRO 140. All participants who resumed HAART regained full viral suppression.
PRO 140 was generally safe and well tolerated. Although overall adverse events were common (more than 90% in the extension phase), there were no drug related or serious adverse events or treatment withdrawal for this reason. All medication-related adverse events were local reactions to the injection, usually mild or moderate.
"For more than a year, the weekly subcutaneous application of PRO140 350mg since full viral suppression was well tolerated and allowed the evasion of potential toxicity from ART while preserving drug options," the researchers concluded. "These results support further development of Pro 140 SC as a single, single, long-term maintenance agent "one of a kind" after the first ART in selected HIV-1 patients. "
They noted that the extension phase of the ongoing study with a plan to further extend monotherapy with the PRO 140 in addition to 120 weeks for patients with continued viral suppression.
Posted in: 28 June 2016
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 monotherapy provides long-term and complete virological suppression in HIV patients. ASM microbe, 2016.
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