Hepatotoxicity and gastrointestinal intolerance when healthy volunteers taking rifampin add twice-daily atazanavir and ritonavir

Journal of Acquired Immune Deficiency Syndromes

Volumn 50, Issue 3, 2009, Pages 290-293

  Haas, David W ^a   Koletar, Susan L ^b   Laughlin, Laura ^b   Kendall, Michelle A ^c   Suckow, Carol ^d   Gerber, John G ^e   Zolopa, Andrew R ^f   Bertz, Richard ^g   Child, Michael J ^g   Hosey, Lara ^h   Alston Smith, Beverly ⁱ   Acosta, Edward P ^j  

^a VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b OHIO STATE UNIVERSITY   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^e UNIVERSITY OF COLORADO   (United States)

^f STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g BRISTOL MYERS SQUIBB   (United States)

^h SOCIAL AND SCIENTIFIC SYSTEMS INC   (United States)

ⁱ NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^j UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

more..

Author keywords

Atazanavir; Hepatotoxicity; Rifampin; Ritonavir; Tuberculosis

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; ATAZANAVIR; RIFAMPICIN; RITONAVIR; OLIGOPEPTIDE; PROTEINASE INHIBITOR; PYRIDINE DERIVATIVE; TUBERCULOSTATIC AGENT;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG DOSE INCREASE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; LIVER TOXICITY; MALE; NAUSEA; OPEN STUDY; PHARMACOKINETICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; VOMITING; DRUG EFFECT; GASTROINTESTINAL TRACT; LIVER;

ADULT; ANTITUBERCULAR AGENTS; FEMALE; GASTROINTESTINAL TRACT; HIV PROTEASE INHIBITORS; HUMANS; LIVER; MALE; OLIGOPEPTIDES; PYRIDINES; RIFAMPIN; RITONAVIR;

EID: 63149110236     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAI.0b013e318189a7df     Document Type: Article

References (24)

1. World Health Organization. Tuberculosis Fact Sheet no. 104. Geneva, Switzerland: World Health Organization; 2007. Available at: http://www.who.int/en/. Accessed October 2008.
2. Panel on Clinical Practices for Treatment of HIV Infection. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Washington, DC: U.S. Department of Health and Human Services; 2008. Available at: http://www.hivatis.org/. Accessed November 2008.
3. Bristol-Myers Squibb Company. Reyataz (atazanavir sulfate) prescribing information [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2008.
4. Johnson M, Grinsztejn B, Rodriguez C, et al. Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures. AIDS. 2005;19:685-694.
5. Acosta EP, Kendall MA, Gerber JG, et al. Effect of concomitantly administered rifampin on the pharmacokinetics and safety of atazanavir administered twice daily. Antimicrob Agents Chemother. 2007;51: 3104-3110.
6. Burger DM, Agarwala S, Child M, et al. Effect of rifampin on steady-state pharmacokinetics of atazanavir with ritonavir in healthy volunteers. Antimicrob Agents Chemother. 2006;50:3336-3342.
7. Division of AIDS Table for Grading Severity of Adult Adverse Experiences. National Institutes of Health; 1992. Available at: http://rcc.tech-res.com/tox-tables.htm. Accessed November 2008.
8. Grange S, Schutz M, Schmitt C, et al. Unexpected hepatotoxicity observed in a healthy volunteer study on the effects of multiple dose rifampicin on the steady-state pharmacokinetics of ritonavir-boosted saquinavir and vice versa. Presented at: Sixth International Workshop on Clinical Pharmacology of HIV Therapy; April 28-30, 2005; Montreal, Quebec, Canada. Abstract 35.
9. Nijland HM, L'homme RF, Rongen GA, et al. High incidence of adverse events in healthy volunteers receiving rifampicin and adjusted doses of lopinavir/ritonavir tablets. AIDS. 2008;22:931-935.
10. 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.
11. World Health Organization. Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach (2006 revision). Geneva, Switzerland: World Health Organization. Available at: http://www.who.int/hiv/pub/guidelines/adult/en/.
12. Ren Y, Nuttall JJ, Egbers C, et al. Effect of rifampicin on lopinavir pharmacokinetics in HIV-infected children with tuberculosis. J Acquir Immune Defic Syndr. 2008;47:566-569.
13. World Health Organization. Tuberculosis Fact Sheet no. 104. Geneva, Switzerland: World Health Organization; 2007. Available at: http://www.who.int/en/. Accessed October 2008.
14. Panel on Clinical Practices for Treatment of HIV Infection. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Washington, DC: U.S. Department of Health and Human Services; 2008. Available at: http://www.hivatis.org/. Accessed November 2008.
15. Bristol-Myers Squibb Company. Reyataz (atazanavir sulfate) prescribing information [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2008.
16. Johnson M, Grinsztejn B, Rodriguez C, et al. Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures. AIDS. 2005;19:685-694.
17. Acosta EP, Kendall MA, Gerber JG, et al. Effect of concomitantly administered rifampin on the pharmacokinetics and safety of atazanavir administered twice daily. Antimicrob Agents Chemother. 2007;51: 3104-3110.
18. Burger DM, Agarwala S, Child M, et al. Effect of rifampin on steady-state pharmacokinetics of atazanavir with ritonavir in healthy volunteers. Antimicrob Agents Chemother. 2006;50:3336-3342.
19. Division of AIDS Table for Grading Severity of Adult Adverse Experiences. National Institutes of Health; 1992. Available at: http://rcc.tech-res.com/tox-tables.htm. Accessed November 2008.
20. Grange S, Schutz M, Schmitt C, et al. Unexpected hepatotoxicity observed in a healthy volunteer study on the effects of multiple dose rifampicin on the steady-state pharmacokinetics of ritonavir-boosted saquinavir and vice versa. Presented at: Sixth International Workshop on Clinical Pharmacology of HIV Therapy; April 28-30, 2005; Montreal, Quebec, Canada. Abstract 35.
21. Nijland HM, L'homme RF, Rongen GA, et al. High incidence of adverse events in healthy volunteers receiving rifampicin and adjusted doses of lopinavir/ritonavir tablets. AIDS. 2008;22:931-935.
22. 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.
23. World Health Organization. Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach (2006 revision). Geneva, Switzerland: World Health Organization. Available at: http://www.who.int/hiv/pub/guidelines/adult/en/.
24. Ren Y, Nuttall JJ, Egbers C, et al. Effect of rifampicin on lopinavir pharmacokinetics in HIV-infected children with tuberculosis. J Acquir Immune Defic Syndr. 2008;47:566-569.