Efficacy and tolerance of combination of maraviroc with MK-0518, boosted TMC-114, TMC-125, in heavily pre-treated CCR5-positive patients

Background

An important problem in treatment-experienced HIV-positive patients is resistance. It could be difficult to find a suitable regimen for heavily pre-treated patients.

Methods

In heavily pre-treated patients in whom we found detectable viral load under adjusted antiretroviral treatment, according to result of resistance and tropism test, we tried a new therapeutic line as combination: MK-0518 + boosted TMC-114 + TMC-125 and maraviroc (all patients were naive to this combination). We measured viral load (Abbot Real time) (<40 copies/ml = undetectable) and CD4 count at day 1, week 3, week 8, week 12 and week 24.

Summary of results

Among six patients who received this combination there are three men and three women. Mean age is 48.7 years (r = 46–50). They have already received 8–19 therapeutic lines (mean = 11), as well as 11–18 (mean = 14) molecules. Mean viral load at day 1 was 35,638 copies/ml = 4.55 log(r = 80–87,100) which is reduced to 76 copies/ml = 1.88 log at week 3, 166 copies/ml = 2.22 log at week 8 and less than 40 copies/ml = 1.6 log = undetectable at week 12. At week 3, 3/6 patients found undetectable viral load and at week 8, 5/6 found undetectable viral load and at week 12 all six patients in therapeutic failure found undetectable viral load. CD4 count, which was 330 (r = 155–649) at day 1, increased to 390 at week 3 and 394 at week 8. We did not find any adverse events in this group of patients.

Conclusion

Combination of TMC-114/R, TMC-125, MK-0518 and maraviroc can be a safe, good option in heavily pre-treated CCR5-positive patients which can reduce viral load 3–4 logs in 3 weeks and reach to undetectable viral load in less than 12 weeks.