People with multidrug resistant HIV reach UD with Trogarzo antibody + ART

[Jim Allen]

Study was aimed at people with multidrug-resistant HIV who during the study were given the antibody treatment Trogarzo (ibalizumab) + ART and they reached viral suppression for a year.

Cool.

In Full: https://www.poz.com/article/trogarzo-can-keep-viral-load-suppressed-least-year

In Short:

The participants had HIV that was resistant to at least one medication in three or more classes of antiretrovirals (ARVs). On day seven of the study they received a 2,000 milligram infusion of Trogarzo. On day 14, they were started on a standard ARV regimen optimized based on drug resistance testing. Starting on day 21, they received an 800 mg infusion of Trogarzo every 14 days.

Seventeen participants (43 percent) achieved a fully suppressed viral load 24 weeks into the study. Of the 31 participants who finished the 24-week study, 27 entered the expanded access phase. Twenty-four of them completed the additional 24 weeks of follow-up; of these, 16 (67 percent) had a fully suppressed viral load at the end of that period.

Of those still on treatment by the end of the expanded access phase, the median reduction in viral load was 2.5log10, or a 99.68 percent reduction.

All 15 of those who entered the expanded access phase with a fully suppressed viral load maintained that status 24 weeks later.

[Jim Allen]

Update & continued good news.

Trogarzo Again Shown Effective Against Highly Resistant HIV

Expanded access study confirms the long-acting monoclonal antibody works well in people with extensive prior treatment. https://www.poz.com/article/trogarzo-shown-effective-highly-resistant-hiv

At this year’s IDWeek, Brinda Emu, MD, of Yale University, and colleagues reported findings from a larger group of 38 people enrolled in the expanded access study, known as TMB-311. Most (87%) were men, and the median age was 53. The median CD4 count was 26, and more than half had levels below 50, indicating advanced immune suppression. Again, they were resistant to antiretrovirals from at least three classes, but their virus remained fully sensitive to at least one drug.

These participants started on Trogarzo plus an optimized background regimen from the outset and did not initially take the antibody alone, unlike those in the previous trial. Here, too, they first received a 2,000 mg infusion followed by 800 mg doses every two weeks.

In this group, 57% experienced a viral load decrease of at least 1.0 log by day 7. Among the 24 participants who completed six months of treatment, 46% had viral loads below 50. The median CD4 count rose by about 30 at week 24.

Among the 17 people who continued treatment through 48 weeks, 47% maintained an undetectable viral load. However, this figure does not include seven people who withdrew from the expanded access program and started taking commercially available Trogarzo after its approval.

In both the Phase III trial and the expanded access cohort, Trogarzo was generally safe and well tolerated. The most common adverse events were diarrhea, headache, nausea, cough, skin rash and fatigue, mostly mild or moderate. No participants reported injection site reactions.

Results from the expanded access program “demonstrate durable viral suppression in this difficult-to-treat patient population,” the researchers concluded.