New Attachment Inhibitor Showing Promise for Treatment-Experienced Patients
April 5, 2016
At the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, 96-week results were reported from a Phase II study of BMS-663068 -- a new class of drugs called attachment inhibitors. This type of drug works by attaching itself onto HIV's receptor called gp120, which helps to prevent HIV from attaching to an immune cell to complete its life cycle. BMS-663068 is being studied in people who are treatment experienced and who often have few to no treatment options.
The study enrolled 254 treatment experienced people, defined as having used one or more HIV drugs for at least one or more weeks, with a viral load >1,000 copies. After a 48-week dose-ranging period (the results from which were reported separately), four-fifths of the study participants then took 1,200mg BMS-663068 while the other one-fifth took atazanavir (Reyataz) boosted with ritonavir. Everyone also took tenofovir (Viread) and raltegravir (Isentress), making for a regimen with three drugs from three different classes.
Average CD4 count at study entry was 230 and average viral load was around 65,000 (with 43% of them >100,000 copies). About half had one or more major resistance mutation against protease inhibitors, NRTIs and NNRTIs. Average age was 39, three out of five were male and 62% were non-white.
Just over two-thirds completed 96 weeks of treatment for this analysis. The average CD4 count change was +219 for those on BMS-663068 and +250 for those on atazanavir. As for viral loads, 90% in each group achieved undetectable levels <50 copies. When looking at the viral load threshold of 100,000 copies, 87% of those taking BMS-663068 and 95% on atazanavir reached <50 copies at 96 weeks. For those with starting viral loads >100,000, 94% on BMS-663068 and 80% on atazanavir reached <50 copies.
Clinical-related events occurred less often in the BMS-663068 group (8.5%) compared to the atazanavir group (37%). Jaundice, abdominal pain, headache and nausea occurred more often in the atazanavir group. However, no one stopped the study due to side effects.
Moderate to serious lab abnormalities occurred in <7% of participants which included neutropenia and changes in ALT and AST, creatinine, glucose and uric acid. Abnormal bilirubin levels occurred in 62% of those on atazanavir, a common side effect of this drug.
E Dejesus, et al, "Attachment Inhibitor Prodrug BMS-663068 in ARV-Experienced Subjects: Week 96 Analysis". 2016 CROI, Boston, MA.
This article was provided by Project Inform. It is a part of the publication The 23rd Conference on Retroviruses and Opportunistic Infections. Visit Project Inform's website to find out more about their activities, publications and services.
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