Once-daily regimen of saquinavir, ritonavir, didanosine, and lamivudine in HIV-infected patients with standard tuberculosis therapy (TBQD study)

Journal of Acquired Immune Deficiency Syndromes

Volumn 40, Issue 3, 2005, Pages 317-323

  Ribera, Esteban ^a   Azuaje, Carlos ^a   Lopez, Rosa M ^a   Domingo, Pere ^b   Soriano, Alex ^c   Pou, Leonor ^a   Sánchez, Paquita ^d   Mallolas, Josep ^c   Sambea, Maria Antonia ^b   Falco, Vicenç ^a   Ocaña, Imma ^a   Lopez Colomes, Josep Lluis ^d   Gatell, Josep M ^c   Pahissa, Albert ^a  

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^b HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^c HOSPITAL CLÍNIC   (Spain)

^d HOSPITAL DEL MAR   (Spain)

Author keywords

Antiretroviral therapy; HIV infection; Pharmacokinetic interaction; Rifampin; Saquinavir; Tuberculosis

Indexed keywords

ABACAVIR; CD4 ANTIGEN; DIDANOSINE; EFAVIRENZ; ETHAMBUTOL; ISONIAZID; ISONIAZID PLUS RIFAMPICIN; LAMIVUDINE; LOPINAVIR; PROTEINASE INHIBITOR; PYRAZINAMIDE; RIFAMPICIN; RITONAVIR; SAQUINAVIR; TENOFOVIR; TUBERCULOSTATIC AGENT; VIRUS RNA;

ACUTE HEPATITIS; ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERCHOLESTEROLEMIA; HYPERTRIGLYCERIDEMIA; LIVER TOXICITY; LOW DRUG DOSE; LYMPHOCYTE COUNT; MALE; MULTICENTER STUDY; PILOT STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; SINGLE BLIND PROCEDURE; TREATMENT FAILURE; TUBERCULOSIS;

ADULT; ANTI-HIV AGENTS; ANTITUBERCULAR AGENTS; DIDANOSINE; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; LAMIVUDINE; LIVER DISEASES; MALE; PILOT PROJECTS; RITONAVIR; SAQUINAVIR; SPAIN; TREATMENT OUTCOME; TUBERCULOSIS;

EID: 27444435253     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.qai.0000182629.74336.4d     Document Type: Article

References (44)

1. Corbett EL, Watt CJ, Walker N, et al. The growing burden of tuberculosis: global trends and interactions with the HIV epidemic. Arch Intern Med. 2003;163:1009-1021.
2. Dufour V, Cadranel J, Wislez M, et al. Changes in the pattern of respiratory diseases necessitating hospitalization of HIV-infected patients since the advent of highly active antiretroviral therapy. Lung. 2004;182:331-341.
3. Jindani A, Nunn AJ, Enarson DA. Two 8-month regimens of chemotherapy for treatment of newly diagnosed pulmonary tuberculosis: international multicentre randomised trial. Lancet. 2004;364:1244-1251.
4. Pozniak AL, Miller R, Ormerod LP. The treatment of tuberculosis in HIV-infected persons. AIDS. 1999;13:435-445.
5. Barnes PF, Lakey DL, Burman WJ. Tuberculosis in patients with HIV infection. Infect Dis Clin North Am. 2002;16:107-126.
6. Yew WW. Clinically significant interactions with drugs used in the treatment of tuberculosis. Drug Saf. 2002;25:111-133.
7. Niemi M, Backman JT, Fromm MF, et al. Pharmacokinetic interactions with rifampin: clinical relevance. Clin Pharmacokinet. 2003;42:819-850.
8. de Jong BC, Israelski DM, Corbett EL, et al. Clinical management of tuberculosis in the context of HIV infection. Annu Rev Med. 2004;55:283-301.
9. Moreno S, Podzamczer D, Blazquez R, et al. Treatment of tuberculosis in HIV-infected patients: safety and antiretroviral efficacy of the concomitant use of ritonavir and rifampin. AIDS. 2001;15:1185-1187.
10. Plosker GL, Scott LJ. Saquinavir: a review of its use in boosted regimens for treating HIV infection. Drugs. 2003;63:1299-1324.
11. Veldkamp AI, Hoetelmans RM, Beijnen JH, et al. Ritonavir enables combined therapy with rifampin and saquinavir. Clin Infect Dis. 1999;29:1586.
12. van Heeswijk RP, Veldkamp AI, Mulder JW, et al. Once daily dosing of saquinavir and low-dose ritonavir in HIV-1-infected individuals: a pharmacokinetic pilot study. AIDS. 2000;14:F103-F110.
13. Cardiello PG, van Heeswijk RP, Hassink EA, et al. Simplifying protease inhibitor therapy with once-daily dosing of saquinavir soft-gelatin capsules/ritonavir (1600/100 mg): HIVNAT 001.3 study. J Acquir Immune Defic Syndr. 2002;29:464-470.
14. Lopez-Cortes LF, Ruiz-Valderas R, Pascual R, et al. Once-daily saquinavir-hgc plus low-dose ritonavir (1200/100 mg) in HIV-infected pregnant women: pharmacokinetics and efficacy. HIV Clin Trials. 2003;4:227-229.
15. Lamotte C, Landman R, Peytavin G, et al. Once-daily dosing of saquinavir soft-gel capsules and ritonavir combination in HIV-1-infected patients (IMEA015 study). Antivir Ther. 2004;9:247-256.
16. Lopez-Cortes LF, Ruiz-Valderas R, Viciana P, et al. Once-daily saquinavir-sgc plus low-dose ritonavir (1200/100 mg) in combination with efavirenz; pharmacokinetics and efficacy in HIV-infected patients with prior antiretroviral therapy. J Acquir Immune Defic Syndr. 2003;32:240-242.
17. World Health Organization Toxicity Criteria by Grade. Available at: http://www.accessdata.fda.gov/scripts/cder/onctools/toxicity.cfm. Accessed September 1, 2005.
18. Ribera E, Lopez RM, Diaz M, et al. Steady-state pharmacokinetics of a double-boosting regimen of saquinavir soft gel plus lopinavir plus minidose ritonavir in Human Immunodeficiency Virus-infected adults. Antimicrob Agents Chemother. 2004;48:4256-4262.
19. Ananworanich J, Sirivichayakul S, Ubolyam S, et al. Different incidence of protease resistance in patients failing treatment on an initial ritonavir-boosted saquinavir (saquinavir/r) regimen vs. those with prior exposure to dual nucleosides and unboosted saquinavir. Paper presented at: XIV International HIV Drug Resistance Workshop; June 7-11, 2005; Quebec, Canada.
20. Walmsley S, Bernstein B, King M, et al. Lopinavir-ritonavir versus nelfinavir for the initial treatment of HIV infection. N Engl J Med. 2002;346:2039-2046.
21. MacManus S, Yates PJ, Elston RC, et al. GW433908/ritonavir once daily in antiretroviral therapy-naive HIV-infected patients: absence of protease resistance at 48 weeks. AIDS. 2004;18:651-655.
22. Narita M, Stambaugh JJ, Hollender ES, et al. Use of rifabutin with protease inhibitors for human immunodeficiency virus-infected patients with tuberculosis. Clin Infect Dis. 2000;30:779-783.
23. Jack C, Lalloo U, Karim QA, et al. A pilot study of once-daily antiretroviral therapy integrated with tuberculosis directly observed therapy in a resource-limited setting. J Acquir Immune Defic Syndr. 2004;36:929-934.
24. Oliva J, Moreno S, Sanz J, et al. Co-administration of rifampin and nevirapine in HIV-infected patients with tuberculosis. AIDS. 2003;17:637-638.
25. Hung CC, Chen MY, Hsiao CF, et al. Improved outcomes of HIV-1-infected adults with tuberculosis in the era of highly active antiretroviral therapy. AIDS. 2003;17:2615-2622.
26. Patel A, Patel K, Patel J, et al. Safety and antiretroviral effectiveness of concomitant use of rifampin and efavirenz for antiretroviral-naive patients in India who are coinfected with tuberculosis and HIV-1. J Acquir Immune Defic Syndr. 2004;37:1166-1169.
27. Dean GL, Edwards SG, Ives NJ, et al. Treatment of tuberculosis in HIV-infected persons in the era of highly active antiretroviral therapy. AIDS. 2002;16:75-83.
28. Dheda K, Lampe FC, Johnson MA, et al. Outcome of HIV-associated tuberculosis in the era of highly active antiretroviral therapy. J Infect Dis. 2004;190:1670-1676.
29. Grupo de Trabajo de los Talleres de 2001 y 2002 de la Unidad de Investigación en Tuberculosis de Barcelona. Prevención y control de las tuberculosis importadas. Med Clin (Barc). 2003;121:549-562.
30. Losso MH, Lourtau LD, Toibaro JJ, et al. The use of saquinavir/ritonavir 1000/100 mg twice daily in patients with tuberculosis receiving rifampin. Antivir Ther. 2004;9:1031-1033.
31. Roche and FDA warning. Drug-induced hepatitis with marked transaminase elevations has been observed in healthy volunteers receiving rifampin 600 mg once daily in combination with ritonavir 100 mg/saquinavir 1000 mg twice daily (ritonavir boosted saquinavir), 2005. Available at: http://www.fda.gov/medwatch. Accessed September 1, 2005.
32. Gordin FM, Cohn DL, Matts JP, et al. Terry Beirn Community Programs for Clinical Research on AIDS; Adult AIDS Clinical Trials Group; Centers for Disease Control and Prevention. Hepatotoxicity of rifampin and pyrazinamide in the treatment of latent tuberculosis infection in HIV-infected persons: is it different than in HIV-uninfected persons? Clin Infect Dis. 2004;39:561-565.
33. Patel SM, Johnson S, Belknap SM, et al. Serious adverse cutaneous and hepatic toxicities associated with nevirapine use by non-HIV-infected individuals. J Acquir Immune Defic Syndr. 2004;35:120-125.
34. Aarnoutse RE, Schapiro JM, Boucher CA, et al. Therapeutic drug monitoring: an aid to optimising response to antiretroviral drugs? Drugs. 2003;63:741-753.
35. Kappelhoff BS, Crommentuyn KM, de Maat MM, et al. Practical guidelines to interpret plasma concentrations of antiretroviral drugs. Clin Pharmacokinet. 2004;43:845-853.
36. Ford J, Boffito M, Wildfire A, et al. Intracellular and plasma pharmacokinetics of saquinavir-ritonavir, administered at 1600/100 milligrams once daily in human immunodeficiency virus-infected patients. Antimicrob Agents Chemother. 2004;48:2388-2393.
37. Autar RS, Ananworanich J, Apateerapong W, et al. Pharmacokinetic study of saquinavir hard gel caps/ritonavir in HIV-1-infected patients: 1600/100 mg once-daily compared with 2000/100 mg once-daily and 1000/100 mg twice-daily. J Antimicrob Chemother. 2004;54:785-790.
38. Boffito M, Dickinson L, Hill A, et al. Pharmacokinetics of once-daily saquinavir/ritonavir in HIV-infected subjects: comparison with the standard twice-daily regimen. Antivir Ther. 2004;9:423-429.
39. van Heeswijk RP, Veldkamp A, Mulder JW, et al. Combination of protease inhibitors for the treatment of HIV-1-infected patients: a review of pharmacokinetics and clinical experience. Antivir Ther. 2001;6:201-229.
40. Justesen US, Andersen AB, Klitgaard NA, et al. Pharmacokinetic interaction between rifampin and the combination of indinavir and low-dose ritonavir in HIV-infected patients. Clin Infect Dis. 2004;38:426-429.
41. la Porte CJ, Colbers EP, Bertz R, et al. Pharmacokinetics of adjusted-dose lopinavir-ritonavir combined with rifampin in healthy volunteers. Antimicrob Agents Chemother. 2004;48:1553-1560.
42. Korenromp EL, Scano F, Williams BG, et al. Effects of human immunodeficiency virus infection on recurrence of tuberculosis after rifampin-based treatment: an analytical review. Clin Infect Dis. 2003;37:101-112.
43. American Thoracic Society, Centers for Disease Control, Infectious Diseases Society of America. Treatment of tuberculosis. MMWR Recomm Rep. 2003;52:1-77.
44. Pulido F, Ribera E, Moreno S, et al. Once-daily antiretroviral therapy: Spanish Consensus Statement. J Antimicrob Chemother. (In press).