Review of tipranavir in the treatment of drug-resistant HIV

Therapeutics and Clinical Risk Management

Volumn 3, Issue 4, 2007, Pages 641-651

  Streeck, Hendrick ^a   Rockstroch, Jürgen Kurt ^a,b  

^a UNIVERSITY OF BONN   (Germany)

^b Department of Medicine I ^*  (Germany)

Author keywords

AIDS; Resistance; Salvage; Tipravanir

Indexed keywords

AMPRENAVIR; AMPRENAVIR PHOSPHATE; AMPRENAVIR PLUS RITONAVIR; ANTACID AGENT; ANTIRETROVIRUS AGENT; ATAZANAVIR; ATORVASTATIN; DELAVIRDINE; DIDANOSINE; EFAVIRENZ; ENFUVIRTIDE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; HYPERICUM PERFORATUM EXTRACT; INDINAVIR; LAMIVUDINE; LOPINAVIR; LOPINAVIR PLUS RITONAVIR; NEVIRAPINE; PRAVASTATIN; PROTEINASE INHIBITOR; RIFAMPICIN; RITONAVIR; RITONAVIR PLUS SAQUINAVIR; RITONAVIR PLUS TIPRANAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR; STAVUDINE; TIPRANAVIR; UNCLASSIFIED DRUG; UNINDEXED DRUG; WARFARIN;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ANOREXIA; ANTIVIRAL ACTIVITY; ARTHRALGIA; ASTHENIA; BRAIN HEMORRHAGE; BRONCHITIS; CD4 LYMPHOCYTE COUNT; CLINICAL TRIAL; DEPRESSION; DIARRHEA; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG INHIBITION; DRUG METABOLISM; DRUG MONITORING; DRUG POTENTIATION; DRUG SUBSTITUTION; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSPEPSIA; EVIDENCE BASED MEDICINE; FATIGUE; FATTY LIVER; FLATULENCE; GASTROINTESTINAL TOXICITY; GENOTYPE PHENOTYPE CORRELATION; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERLIPIDEMIA; HYPERTRIGLYCERIDEMIA; JOINT STIFFNESS; LACTIC ACIDOSIS; LEUKOCYTE COUNT; LIVER INJURY; LIVER TOXICITY; LONG TERM CARE; LOOSE FECES; MACULOPAPULAR RASH; METABOLIC DISORDER; MITOCHONDRIAL TOXICITY; MONOTHERAPY; MULTIDRUG RESISTANCE; NAUSEA; NEUROLOGIC DISEASE; NONHUMAN; NUTRITIONAL DISORDER; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PHOTOSENSITIVITY; PROGNOSIS; PRURITUS; RECOMMENDED DRUG DOSE; REVIEW; SIDE EFFECT; SKIN TOXICITY; THROAT TIGHTNESS; TOXIC HEPATITIS; UNSPECIFIED SIDE EFFECT; VIRUS LOAD; VIRUS MUTATION; VIRUS RESISTANCE; VOMITING;

EID: 34848887694     PISSN: 11766336     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (50)

1. Back NK, van Wijk A, Remmerswaal D, et al. 2000. In vitro tipranavir susceptibility of HIV-1 isolates with reduced susceptibility to other protease inhibitors. Aids, 14:101-2.
2. Bartlett JA, DeMasi R, Quinn J, et al. 2001. Overview of the effectiveness of triple combination therapy in antiretroviral-naive HIV-1 infected adults. Aids, 15:1369-77.
3. Boden D, Hurley A, Zhang L, et al. 1999. HIV-1 drug resistance in newly infected individuals. JAMA, 282:1135-41.
4. Boehringer Ingelheim. 2004. Unpublished data. Boehringer Ingelheim GmbH Investigator's Brochure.
5. Boehringer Ingelheim GmbH International. 2005. Aptivus (tipranavir) Capsules-SPC.
6. Boehringer Ingelheim GmbH International. 2005. Product Monograph, Aptivus (tipranavir).
7. Boehringer Ingelheim Pharmaceuticals Inc. 2005. Aptivus (tipranavir) Capsules-Prescribing Information.
8. Boffito M, Maitland D, Pozniak A. 2006. Practical perspectives on the use of tipranavir in combinations with other medications: Lessons learned from pharmacokinetic studies. J Clin Pharmacol, 46:130-9.
9. Cahn P, Hicks C, and Teams, f.t.R.-a.R.-S. 2005. RESIST-I (R-I) and RESIST-2 (R-2) 48 week meta-analyses demonstrate superiority of protease inhibitor (PI) tipranavir+ritonavir (TPV/r) over an optimized comparator PI (CPI/r) regimen in antiretroviral (ARV) experienced patients. 10th European AIDS Conference (EACS), Dublin, Ireland, 17-20 November 2005, Abs. # PS3/8.
10. Carpenter CC, Cooper DA, Fischl MA, et al. 2000. Antiretroviral therapy in adults: Updated recommendations of the international AIDS society-U S A Panel. JAMA, 283:381-90.
11. Chen RY, Westfall AO, Mugavero MJ, et al. 2003. Duration of highly active antiretroviral therapy regimens. Clin Infect Dis, 37:714-22.
12. Clavel F, Hance AJ. 2004. HIV drug resistance. N Engl J Med, 350:1023-35.
13. Clotet B, Raffi F, Cooper D, et al. 2004. Clinical management of treatment-experienced, HIV-infected patients with the fusion inhibitor enfuvirtide: consensus recommendations. Aids, 18:1137-46.
14. Cooper D, Hicks C, Cahn P, et al. 2005. 24-week RESIST study analyses: The efficacy of tipranavir/ritonavir is superior to lopinavir/ritonavir, and the TPV/r treatment response is enhanced by inclusion of geno-typically active antiretrovirals in the optimized background regimen. Conference on Retroviral and Opportunistic Infections (CROI), Boston, MA, 2005, Abs # 560.
15. Doyon L, Tremblay S, Bourgon L, et al. 2005. Selection and characterization of HIV-1 showing reduced susceptibility to the non-peptidic protease inhibitor tipranavir. Antiviral Res, 68:27-35.
16. Gathe J, Kohlbrenner VM, Pierone G, et al. 2003. Tipranavir/ritonavir demonstrates potent efficacy in multiple protease inhibitor experienced patients: BI 1182.52. 10th Conference on Retroviral an Opportunistic Infections (CROI), Boston, Abs. # 179.
17. GmbH BI. 2004. Investigator's Brochure.
18. Gong YF, Robinson BS, Rose RE, et al. 2000. In vitro resistance profile of the human immunodeficiency virus type 1 ptotease inhibitor BMS-232632. Antimicrob Agents Chemother, 44:2319-26.
19. Hicks C. 2004. RESIST-1: A phase 3, randomized, controlled, open-label, multicenter trial comparing tipranavir/ritonavir (TPV/r) to an optimized comparator protease inhibitor/r (CPI/r) regimen in antiretroviral (ARV) experienced patients: 24-week trial. 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, October 30 - November 2, Washington, DC; 2004, Abstract H-1137a.
20. Hicks C, Cahn CP, Cooper DA, et al; for the RESIST Investigator Group. 2006. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet, 368:466-75.
21. Jacobsen H, Yasargil K, Winslow DL, et al. 1995. Characterization of human immunodeficiency virus type 1 mutants with decreased sensitivity to proteinase inhibitor Ro 31-8959. Virology, 206:527-34.
22. Johnson VA, Brun-Vezinet F, Clotet B, et al. 2005. Update of the drug resistance mutations in HIV-1: 2005. Top HIV Med, 13:51-7.
23. Jones JL, Hanson DL, Dworkin MS, et al. 1999. Surveillance for AIDS-defining opportunistic illnesses, 1992-1997. MMWR CDC Surveill Summ, 48:1-22.
24. Katlama C, Berger D, Bellos N, et al. 2005. Efficacy of TMC114/r in 3-class experienced patients with limited treatment options: 24-week planned interim analysis of 2 96-week multinational dose-finding Trials. Conference on Retroviral and Opportunistic Injections (CROI), Boston, MA, 2005, 164LB.
25. Kemp SD, Salim M, Field N, et al. 2000. Site-directed mutagenesis and in vitro drug selection studies have failed to reveal a consistent genotypic resistance pattern for tipranavir. Interscience Conference on Antimicrobial Agents and chemotherapy, Abstract # 2113.
26. King NM, Prabu-Jeyabalan M, Nalivaika EA, et al. 2004. Structural and thermodynamic basis for the binding of TMC114, a next-generation human immunodeficiency virus type 1 protease inhibitor. J Virol, 78:12012-21.
27. Koh Y, Nakata H, Maeda K, et al. 2003. Novel bis-tetrahydrofurany-lurethane-containing nonpeptidic protease inhibitor (PI) UIC-94017 (TMC114) with potent activity against multi-PI-resistant human immunodeficiency virus in vitro. Antimicrob Agents Chemother, 47:3123-9.
28. Lampe F, Gatell J, Staszewski S, et al. 2005. Trends over time in initial virological failure of first HAART: 1996 to 2002. A joint cohort Analysis of 4143 subjects conference on retroviral and opportunistic infections (CROI), Boston, MA, 2005, Abstr. # 593.
29. Larder BA, Hertogs K, Bloor S, et al. 2000. Tipranavir inhibits broadly protease inhibitor-resistant HIV-1 clinical samples. Aids, 14:1943-8.
30. Leith J, Walmsley S, Katlama C, et al. 2004. Pharmacokinetics and safety of Tipranavir/Ritonavir (TPV/r) Alone or in Combination with Saquinavir (SQV), Amprenavir (APV), or Lopinavir (LPV): Interim analysis of BI1182.51. 5th International Workshop on Clinical Pharmacology of HIV Therapy, Rome. Italy, session 5 Abs. 5.1.
31. Little SJ, Holte S, Routy JP, et al. 2002. Antiretroviral-drug resistance among patients recently infected with HIV. N Engl J Med, 347:385-94.
32. Markowitz M, Mo H, Kempf DJ, et al. 1995. Selection and analysis of human immunodeficiency virus type 1 variants with increased resistance to ABT-538, a novel protease inhibitor. J Virol, 69:701-6.
33. Markowitz M, Mohri H, Mehandru S, et al. 2005. Infection with multidrug resistant, dual-tropic HIV-1 and rapid progression to AIDS: a case report. Lancet, 365:1031-8.
34. McCallister S, Valdez H, Curry K, et al. 2004. A 14-day dose-response study of the efficacy, safety, and pharmacokinetics of the nonpeptidic protease inhibitor tipranavir in treatment-naive HIV-1-infected patients. J Acquir Immune Defic Syndr, 35:376-82.
35. Montaner JS. 2003. Challenges of the unmet needs in the treatment-experienced patient. AIDS Read, 13:S5-9.
36. Palella FJ Jr, Delaney KM, Moorman AC, et al. 1998. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med, 338:853-60.
37. Pierone G, Drulak M, Arasteh K, et al. 2005. A long-term open-label rollover trial assessing the safety and tolerability of combination tipranavir and ritonavir (TPV/r) Use in HIV-1-infected patients. The 3rd IAS Conference on HIV Pathogenesis and Treatment (IAS 2005) July 24-27, 2005; Rio de Janeiro, Brazil Poster WePe6.2C05.
38. Polis MA, Sidorov IA, Yoder C, et al. 2001. Correlation between reduction in plasma HIV-1 RNA concentration 1 week after start of antiretroviral treatment and longer-term efficacy. Lancet, 358:1760-5.
39. Poppe SM, Slade DE, Chong KT, et al. 1997. Antiviral activity of the dihydropyrone PNU-140690, anew nonpeptidic human immunodeficiency virus protease inhibitor. Antimicrob Agents Chemother, 41:1058-63.
40. Richman DD, Morton SC, Wrin T, et al. 2004. The prevalence of antiretroviral drug resistance in the United States. Aids, 18:1393-1401.
41. Rockstroh J, Sulkowski M, Neubacher D, et al. 2005. 24-Week Efficacy of tipranavir boosted with ritonavir (TPV/r) in Hepatitis B (HBV) or Hepatitis C (HCV) Co-Infected Patients. 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington D.C., December 16-19th, 2005, H-525.
42. Rockstroh J, Villacian J, Quinson A, et al. 2005. 24-week analysis of the efficacy of tipranavir boosted with ritonavir (TPV/r) in HIV patients stratified by previous protease inhibitor (PI) Use. 10th European AIDS Conference (EACS). November 17-20, 2005, Dublin, Ireland, PE7.9/11.
43. Rusconi S, La Seta Catamancio S, Citterio P, et al. 2000. Susceptibility to PNU-140690 (Tipranavir) of human immunodeficiency virus type 1 isolates derived from patients with multidrug resistance to other protease inhibitors. Antimicrob Agents Chemother, 44:1328-32.
44. Schwartz R, Kazanjian P, Slater L, et al. 2002. Resistance to tipranavir is uncommon in a randomized trial of tipranavir/ritonavir (TPV/RTV) in Multiple PI-Failure Patients (BI 1182.2). 9th Conference on Retroviruses and Opportunistic Infections, 2002, Seattle, WA Session 75, Poster Session 562-T.
45. Thaisrivongs S, Strohbach JW. 1999. Structure-based discovery of Tipranavir disodium (PNU-140690E): a potent, orally bioavailable, nonpeptidic HIV protease inhibitor. Biopolymers, 51:51-8.
46. Van Heeswijk R, Sabo J, Cooper C, et al. 2004. The pharmacokinetic interaction between tipranavir/ritonavir 500/200 mg bid (TPV/r) and atorvastatin, antacid, and CYP3A4 in healthy adult volunteers. 5th International Workshop on Clinical Pharmacology of HIV Therapy, Rome, Italy, Abstract #35.
47. van Leth F, Phanuphak P, Ruxrungtham K, et al. 2004. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet, 363:1253-63.
48. Wilkirt T, Haubrich R, Steinhart C, et al. 2005. TMC114/r Superior to Standard of Care in 3-Class-Experienced Patients: 24-Wks Primary Analysis of the Power 2 Study (C202). 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington D.C., December 16-19th, 2005, H-413.
49. Wu A, Huang I, Lobo F, et al. 2005. Health-related quality of life with tipranavir in combination with an optimized background regimen in 2 randomized clinical trials. 12th Conference on Retroviruses and Opportunistic Infections February 22-25, 2005, Boston, Massachusetts, Poster #654.
50. Yeni PG, Hammer SM, Hirsch MS, et al. 2004. Treatment for adult HIV infection: 2004 recommendations of the International AIDS Society-USA Panel. JAMA, 292:251-65.