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  • Oral presentation
  • Open Access

Maraviroc (MVC) increases CD4+ and CD8+ cells: long-term data from the MVC clinical development program

  • 1,
  • 2,
  • 3,
  • 4,
  • 5,
  • 6,
  • 5,
  • 6,
  • 6,
  • 6 and
  • 7
Journal of the International AIDS Society201013 (Suppl 4) :O45

https://doi.org/10.1186/1758-2652-13-S4-O45

  • Published:

Keywords

  • Great Increase
  • Load Change
  • Maraviroc
  • Background Therapy
  • Clinical Development Program

Background

Across the MVC development program, patients who received MVC-containing regimens experienced greater increases in CD4+ cell counts than those observed in comparator arms in primary analyses. Here we present longer term immunological data from this program.

Material and methods

Long-term (96 week) data from subjects with CCR5-tropic HIV infection in the following ongoing MVC studies were included in the analysis: (1) MOTIVATE study (MVC QD and BID vs placebo (PBO), each combined with optimized background therapy in treatment-experienced [TE] subjects); and (2) MERIT study (MVC BID vs EFV, each combined with ZDV/3TC in treatment-naïve [TN] subjects). Additionally, interim week 24 data from the ongoing 96-week 1078 study (MVC QD vs TDF/FTC, each combined with ATV/r in TN subjects) were summarized. Descriptive statistics are presented for data at baseline and at week 96 (MERIT/MOTIVATE) or week 24 (1078) pertaining to change in CD4+ and CD8+ cells.

Results

Greater increases in CD4+ cells in MVC-containing groups persisted through 96 weeks in the MOTIVATE and MERIT studies, and through 24 weeks in the 1078 study (Table 1). Similarly, changes in CD8+ cells from baseline to weeks 96 or 24 favored MVC-containing regimens in all three studies. In a combined LOCF analysis of patients from all three studies at week 24, CD4+ counts increased by a median 100.5 cells/µL in 1260 recipients of MVC-containing regimens, compared with 84.5 cells/µL in 631 recipients of comparator regimens; CD8+ counts increased by a median 153 cells/µL in the MVC group, compared with a decrease of 61 cells/µL in the comparator group. At week 96, a combined analysis of patients from the MOTIVATE and MERIT studies showed median CD4+ increases from baseline of 129.5 and 100.3 cells/µL in the MVC (N=1177) and comparator (N=554) groups, respectively; CD8+ changes were 96 and -72 cells/µL, respectively. In all studies, differences in CD4+ and CD8+ counts between treatment groups were independent of differences in viral load changes (data not shown).

Table 1

Population

Treatment-experienced

Treatment-naive

Study

MOTIVATE – 96 Weeks

MERIT – 96 Weeks

1078 – 24 Weeks

Arm

MVC QD

MVC BID

PBO

MVC BID

EFV

MVC QD

TDF/FTC

N

414

426

209

360

361

60

61

BL HIV RNA (median log10 cp/mL)

4.86

4.85

4.86

4.88

4.85

4.59

4.66

Baseline CD4 count (median cells/µL)

171

167

171

244.3

258.5

344.5

358.0

Baseline CD8 count (median cells/µL)

867.5

836.5

820.8

791.5

860.0

859.8

890.0

CD4 change from BL (median cells/µL)

89.0

112.5

21.0

224.3

195.0

195.3

173.0

CD8 change from BL (medican cells/µL)

138.0

157.0

31.5

-3.00

-94.5

4.5

-78.5

Conclusions

Greater increases in CD4+ and CD8+ counts were consistently achieved with MVC-containing regimens, compared to regimens without MVC, and persisted through at least 2 years of therapy in both TN and TE patients. These differences were independent of changes in HIV-1 RNA and are evident with multiple different MVC-containing regimens.

Authors’ Affiliations

(1)
San Raffaele Scientific Institute, Milano, Italy
(2)
Dept. of Immunology & Infectious Diseases INNSZ, Mexico City, Mexico
(3)
Univ. Hosp, Basel, Switzerland
(4)
Pfizer Inc, New York, USA
(5)
Pfizer Global Research, New London, USA
(6)
Pfizer Inc, New York, USA
(7)
Pfizer, 50 Pequot Ave, New London, USA

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