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A filter-based cross-sectional analysis of an HIV-positive, HAART-treated cohort in rural Burundi: pharmacokinetics, pharmacogenetics and viral load

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Journal of the International AIDS Society201013 (Suppl 4) :P179

https://doi.org/10.1186/1758-2652-13-S4-P179

  • Published:

Keywords

  • Viral Load
  • Efavirenz
  • Nevirapine
  • Undetectable Viral Load
  • Detectable Viral Load

Background

In Burundi Triomune® is the first-line HIV treatment and it is estimated to reach 30% of those in need, but efficacy monitoring does not rely on viral load (VL) quantification, due to cost and technical limitations. Furthermore nevirapine (NVP) is known to have a highly variable pharmacokinetics (PK) and pharmacogenetics (PG), but no data are currently available in this population.

Purpose of the study

To study virological outcome, PK and PG of nevirapine-based HAART in Burundi, by relying on previously validated alternative tools for samples collection.

Materials and methods

A cross-sectional analysis was performed at the rural hospital of Kiremba, northern Burundi. All patients on HAART (>6 months) presenting for care and willing to participate were enrolled. After sample collection, whole blood (50 µL) was spotted on Whatman 903 Cards (Dried Blood Spot, DBS); afterwards plasma (100 µL, after centrifugation) was spotted on glass paper filter (dried plasma spots, DPS). DBS were used for VL testing (NucliSENS EasyQ HIV-1 v2.0) and PG analysis (516G>T and 983C>T SNPs in CYP2B6, 3435C>T and 1236 C>T in MDR1). A validated HPLC method was used to measure NNRTIs concentrations on DPS.

Results

239 patients (68.2% female) were enrolled; mean (±SD) age and BMI were respectively 37.9 years (±10) and 20.7 Kg/m2 (±2.8). The majority of them (90.8%) were in WHO stage 3 and last CD4+ cell count was 543 cell/mm3 (±345). 237 were on first line treatment (220 on NVP and 17 on EFV) and 2 (0.8%) on second line (LPV/r). Mean time on treatment was 25.7 months (±13.7) and it correlated to the last CD4+ count (Pearson 0.23, p=0.001). 43 (18%) had a detectable viral load with 14 patients (5.8%) having more than 800 copies/ml. Nevirapine and efavirenz Ctrough were 7727 ng/ml (± 3796) and 4027 ng/ml (± 3041). CYP2B6 mutated SNPs were common (48,5% in 516G>T, 13,6% in 983C>T) and associated to increasing exposure (p=0.01 and p=0.02). A higher proportion of patients (95.6% vs. 88.5%, p>0.05) had viral loads below 800 copies/ml in the higher range of NVP concentration (Ctrough >4300 ng/ml).

Conclusions

DPS and DBS showed to be useful tools to collect and transport samples from a rural area of Burundi. Even with the limit of a cross-sectional analysis a high effectiveness was noted, showing 82% of patients with undetectable VL at a mean of 2 years since start of treatment. High NVP plasma concentrations along with favorable genetic profile could partially explain these results.

Authors’ Affiliations

(1)
Department of Infectious Diseases, University of Torino, Torino, Italy
(2)
Ospedale Amedeo di Savoia, ASLTO2, Microbiology and Virology Laboratory, Torino, Italy
(3)
University of Torino, Pharmacokinetics and Pharmacogenetics Laboratory, Torino, Italy
(4)
Hopital de Kiremba, Kiremba, Ngozi, Burundi

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