Abstract
Objectives: Our objective was to evaluate the pharmacokinetics of nelfinavir (NFV) (625 mg tablets) 1250 mg twice daily during pregnancy and postpartum. Methods: The participants were HIV-1-infected pregnant women enrolled in P1026s and receiving NFV (625 mg tablets) 1250 mg twice daily as part of routine clinical care. Intensive steady-state 12-h NFV pharmacokinetic profiles were performed during pregnancy and postpartum. The target NFV area under the plasma concentration-time curve (AUC0-12) was ≥ 10th percentile NFV AUC0-12 in non-pregnant historical controls (18.5 μgh/mL). Results: Of 27 patients receiving NFV, pharmacokinetic data were available for four (second trimester), 27 (third trimester) and 22 (postpartum) patients. The NFV maximum concentration (Cmax), 12-h post-dose concentration (C12) and AUC0-12 were significantly lower during the third trimester compared to postpartum (P ≤ 0.03). The metabolite hydroxyl-tert-butylamide (M8) AUC0-12 and the M8/NFV AUC ratio were lower during the third trimester compared to postpartum (P < 0.01). The NFV AUC0-12 exceeded the AUC0-12 target for 15/27 (56%) and 21/22 (95%) of third trimester and postpartum patients, respectively. The minimum concentration (Cmin) was above the suggested minimum trough concentration (0.8 μg/mL) in 15% (third trimester) and 18% (postpartum). The plasma viral load was < 400HIV-1 RNAcopies/mL in 81% of patients at delivery. Conclusions: These results suggest that higher doses of NFV should be considered during pregnancy.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 875-882 |
| Number of pages | 8 |
| Journal | HIV Medicine |
| Volume | 9 |
| Issue number | 10 |
| DOIs | |
| State | Published - Nov 2008 |
| Externally published | Yes |
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Keywords
- HIV
- Nelfinavir
- Pharmacokinetics
- Pregnancy
ASJC Scopus subject areas
- Infectious Diseases
- Pharmacology (medical)
- Health Policy
Cite this
Pharmacokinetics of new 625mg nelfinavir formulation during pregnancy and postpartum. / Read, Jennifer S.; Best, B. M.; Stek, A. M.; Hu, Chengcheng; Capparelli, E. V.; Holland, D. T.; Burchett, S. K.; Smith, M. E.; Sheeran, E. C.; Shearer, W. T.; Febo, I.; Mirochnick, M.
In: HIV Medicine, Vol. 9, No. 10, 11.2008, p. 875-882.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Pharmacokinetics of new 625mg nelfinavir formulation during pregnancy and postpartum
AU - Read, Jennifer S.
AU - Best, B. M.
AU - Stek, A. M.
AU - Hu, Chengcheng
AU - Capparelli, E. V.
AU - Holland, D. T.
AU - Burchett, S. K.
AU - Smith, M. E.
AU - Sheeran, E. C.
AU - Shearer, W. T.
AU - Febo, I.
AU - Mirochnick, M.
PY - 2008/11
Y1 - 2008/11
N2 - Objectives: Our objective was to evaluate the pharmacokinetics of nelfinavir (NFV) (625 mg tablets) 1250 mg twice daily during pregnancy and postpartum. Methods: The participants were HIV-1-infected pregnant women enrolled in P1026s and receiving NFV (625 mg tablets) 1250 mg twice daily as part of routine clinical care. Intensive steady-state 12-h NFV pharmacokinetic profiles were performed during pregnancy and postpartum. The target NFV area under the plasma concentration-time curve (AUC0-12) was ≥ 10th percentile NFV AUC0-12 in non-pregnant historical controls (18.5 μgh/mL). Results: Of 27 patients receiving NFV, pharmacokinetic data were available for four (second trimester), 27 (third trimester) and 22 (postpartum) patients. The NFV maximum concentration (Cmax), 12-h post-dose concentration (C12) and AUC0-12 were significantly lower during the third trimester compared to postpartum (P ≤ 0.03). The metabolite hydroxyl-tert-butylamide (M8) AUC0-12 and the M8/NFV AUC ratio were lower during the third trimester compared to postpartum (P < 0.01). The NFV AUC0-12 exceeded the AUC0-12 target for 15/27 (56%) and 21/22 (95%) of third trimester and postpartum patients, respectively. The minimum concentration (Cmin) was above the suggested minimum trough concentration (0.8 μg/mL) in 15% (third trimester) and 18% (postpartum). The plasma viral load was < 400HIV-1 RNAcopies/mL in 81% of patients at delivery. Conclusions: These results suggest that higher doses of NFV should be considered during pregnancy.
AB - Objectives: Our objective was to evaluate the pharmacokinetics of nelfinavir (NFV) (625 mg tablets) 1250 mg twice daily during pregnancy and postpartum. Methods: The participants were HIV-1-infected pregnant women enrolled in P1026s and receiving NFV (625 mg tablets) 1250 mg twice daily as part of routine clinical care. Intensive steady-state 12-h NFV pharmacokinetic profiles were performed during pregnancy and postpartum. The target NFV area under the plasma concentration-time curve (AUC0-12) was ≥ 10th percentile NFV AUC0-12 in non-pregnant historical controls (18.5 μgh/mL). Results: Of 27 patients receiving NFV, pharmacokinetic data were available for four (second trimester), 27 (third trimester) and 22 (postpartum) patients. The NFV maximum concentration (Cmax), 12-h post-dose concentration (C12) and AUC0-12 were significantly lower during the third trimester compared to postpartum (P ≤ 0.03). The metabolite hydroxyl-tert-butylamide (M8) AUC0-12 and the M8/NFV AUC ratio were lower during the third trimester compared to postpartum (P < 0.01). The NFV AUC0-12 exceeded the AUC0-12 target for 15/27 (56%) and 21/22 (95%) of third trimester and postpartum patients, respectively. The minimum concentration (Cmin) was above the suggested minimum trough concentration (0.8 μg/mL) in 15% (third trimester) and 18% (postpartum). The plasma viral load was < 400HIV-1 RNAcopies/mL in 81% of patients at delivery. Conclusions: These results suggest that higher doses of NFV should be considered during pregnancy.
KW - HIV
KW - Nelfinavir
KW - Pharmacokinetics
KW - Pregnancy
UR - http://www.scopus.com/inward/record.url?scp=55649098604&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=55649098604&partnerID=8YFLogxK
U2 - 10.1111/j.1468-1293.2008.00640.x
DO - 10.1111/j.1468-1293.2008.00640.x
M3 - Article
VL - 9
SP - 875
EP - 882
JO - HIV Medicine
JF - HIV Medicine
SN - 1464-2662
IS - 10
ER -