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HIV Treatment Bulletin Volume 7 Number 4 April 2006

ISSN 1472-4683. Published by i-Base.

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CROI: PHARMACOLOGY & DRUG INTERACTIONS

Pharmacology and drug interaction studies in adults: summary table from CROI, ICAAC and EACS conferences

Simon Collins, HIV i-Base

The following table includes summaries of non-pregnant adult PK and drug-drug interaction studies from the three most recent major HIV conferences: 13th CROI, 45th ICAAC and 10th EACS.

Studies relating to pharmacology during pregnancy are covered in separate reports in this issue of HTB and the paediatric studies will be included in the May edition of HTB.

All abstracts are available online at the respective conference websites. Abstracts from EACS and CROI are also archived on the AEGiS.org conference database. ICAAC abstracts are usually removed from any public online access several months after the conference.

Please consult abstracts for full study for details.

The 13th Conference on Retroviruses and Opportunistic Infections Open link in new window
http://www.retroconference.org

46th Annual International Conference on Antimicrobial Agents and Chemotherapy (ICAAC)Open link in new window
http://www.icaac.org/

The 10th European AIDS Conference/EACS Open link in new window
http://www.eacs-conference2005.com/

HIV / AIDS Information on the Internet, provided by AEGISOpen link in new window
http://www.aegis.org/

Table 1 – PK and drug interaction studies at CROI, ICAAC and EACS

Table 1: PSS (phenotypic sensitivity score) View table | View in new window

comment

The food interaction study with TMC114 was well designed with a specific range of different options. Although it is likely that TMC114 will be recommended to ‘take with food’ it is useful to know that ‘coffee and croissant’ is sufficient.

The interaction between the Meltrex formulation of lopinavir/r (Kaletra) and efavirenz is the first time that NNRTIs have been shown to increase levels of a PI. This is interesting, although patient variability may make this positive interaction less reliable in an individual patient, hence the recommendation to increase the Meltrex dose in treatment experienced patients.

The interaction between lopinavir/r (Kaletra) which increased rosuvastatin by 150-200% was unexpected as rosuvastatin is not mediated by CYP 3A4 pathway. This highlights the importance of real in vivo interaction studies, and the limitations of recommendations based only on a theoretical likelihood of an interaction.

Links to HIV pharmacology websites:

HIV PharmacologyOpen link in new window
http://www.HIVpharmacology.com

References

1. Sekar V et al. The effects of different meal types on the PK of TMC114 tablet formulation dosed with ritonavir in healthy volunteers. 10th European AIDS Conference. November 17-20, 2005. Dublin. Abstract PE4.1/1.
2. Sekar V et al. Pharmacokinetc interraction between TMC114/ritonavir and atazanavir in healthy volunteers. 10th European AIDS Conference. November 17-20, 2005. Dublin. PE 4.3/4.
3. Boffito M, Winston A, Fletcher C et al. Pharmacokinetics and ART response to TMC114/r and TMC125 combination in patients with high-level viral resistance. Abstract 575c.
4. Scholler et al. Significant decrease in TMC125 exposures when co-administered with tipranavir boosted with ritonavir in healthy subjects. 13th CROI. Abstract 583.
5. Hoetelmans R et al. Pharmacokinetic interaction between TMC278, and investigational NNRTI and lopinavir/r in healthy volunteers. 10th EACS. Abstract PE4.3/1.
6. Klein C, Zhu T, Chiu YL, et al. Effect of efavirenz on lopinavir/ritonavir pharmacokinetics from a new tablet formulation. 10th European AIDS Conference. November 17-20, 2005. Dublin. Abstract PE4.3/2.
7. Winston A, Back D, Fletcher C, et al. Effect of omeprazole on the pharmacokinetics of saquinavir 500 mg formulation with ritonavir in healthy male and female volunteers. 10th European AIDS Conference. November 17-20, 2005. Dublin. Abstract LBPE4.3/16.
8. Klein C et al. Lack of effect of acid-reducing agents on the pharmacokinetics of lopinavir/ritonavir tablet. 13th CROI. Abstract 578.
9. Tomilo et al. The effect of lansoprazole acid suppression on the pharmacokinetics of atazanavir in healthy volunteers. 45th ICAAC. Abstract A-1192.
10. Mallolas J et al. Pharmacokinetic interaction between rifampin and the combination of atazanavir and low dose ritonavir in HIV-infected patients. 45th ICAAC. Abstract A-1202.
11. Chen Y et al. Pharmacokinetic interaction between rifabutin (RFB) and fosamprenavir (FPV)/ritonavir (RTV) in healthy subjects. 45th ICAAC. Abstract A-1199.
12. Pujari S et al. Effect of rifampin hepatic induction on nevirapine levels in Indian volunteers. 13th CROI. Abstract574.
13. Van Der Lee M et al Pharmacokinetics and pharmacodynamics of combined use of lopinavir/ritonavir and rosuvastatin in HIV-infected patients. 13th CROI. Abstract 588
14. Judith A. Aberg, Susan L. Rosenkranz, Carl J. Fichtenbaum, Beverly L. Alston, Susan W. Brobst, Yoninah Segal, John G. Gerber, for the ACTG A5108 team. Pharmacokinetic interaction between nelfinavir and pravastatin in HIV-seronegative volunteers: ACTG Study A5108. AIDS 2006;20:725-729.
15. Kaul S et al A 2-way pharmacokinetic interaction between efavirenz and carbamazepine. 13th CROI. Abstract 575a.
16. Wyen C, Jetter A, Frank D, et al. CYP2D6 is inhibited by lopinavir/ritonavir in HIV-infected patients. European AIDS Conference. November 17-20, 2005. Dublin. Abstract PE4.1/6.

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