Efficacy of indinavir-ritonavir-based regimens in HIV-1-infected patients with prior protease inhibitor failures

AIDS

Volumn 17, Issue 13, 2003, Pages 1933-1939

  Campo, Rafael E ^a,c   Moreno, Jose N ^a   Suarez, German ^a   Miller, Nancimae ^a   Kolber, Michael A ^a   Holder, Daniel J ^b   Shivaprakash, Malathi ^b   DeAngelis, Dana M ^b   Wright, Jennifer L ^b   Schleif, William A ^b   Emini, Emilio A ^b   Condra, Jon H ^b  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^b Department of Biometrics Research ^*  (United States)

^c Division of Disease Prevention   (United States)

Author keywords

Adherence; Genotypic resistance; Increased drug exposure; Indinavir; Phenotypic resistance; Ritonavir; Salvage therapy

Indexed keywords

ABACAVIR; ANTIRETROVIRUS AGENT; DIDANOSINE; EFAVIRENZ; INDINAVIR; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; VIRUS RNA;

ADULT; ARTICLE; CLINICAL ARTICLE; DRUG EFFICACY; DRUG EXPOSURE; DRUG POTENCY; FEMALE; GENOTYPE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IC 50; MALE; NONHUMAN; PATIENT COMPLIANCE; PHENOTYPE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; TREATMENT FAILURE; VIRUS LOAD; VIRUS RESISTANCE;

DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; GENOTYPE; HIV INFECTIONS; HIV PROTEASE; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; INDINAVIR; MALE; PATIENT COMPLIANCE; PHENOTYPE; RETROSPECTIVE STUDIES; RITONAVIR; SALVAGE THERAPY; TREATMENT FAILURE; VIRAL LOAD;

EID: 0041327657     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002030-200309050-00012     Document Type: Article

References (43)

1. Palella FJ, Jr., Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1998, 338:853-860.
2. Hogg RS, Heath KV, Yip B, Craib K, O'Shaughnessy MV, Schechter MT, et al. Improved survival among HIV-infected individuals following initiation of antiretroviral therapy. JAMA 1998, 279:450-454.
3. Hogg RS, O'Shaughnessy MV, Gataric N, Yip B, Craib KJP, Schechter MT, et al. Decline in deaths from AIDS due to new antiretrovirals. Lancet 1997, 349:1294.
4. Lucas GM, Chaisson RE, Moore RD. Highly active antiretroviral therapy in a large urban clinic: risk factors for virologic failure and adverse drug reactions. Ann Intern Med 1999, 131:81-87.
5. Hirsch MS, Brun-Vezinet F, D'Aquila RT, Hammer SM, Johnson VA, Kuritzkes DR, et al. Antiretroviral drug resistance testing in adult HIV-1 infection: recommendations of an International AIDS Society-USA Panel. JAMA 2000, 282:2417-2426.
6. Descamps D, Flandre P, Calvez V, Peytavin G, Meiffredy V, Collin G, et al. Mechanisms of virological failure in previously untreated HIV-infected patients from a trial of induction-maintenance therapy. JAMA 2000, 283:205-211.
7. Havlir DV, Hellman NS, Petropoulos CJ, Whitcomb JM, Collier AC, Hirsch MS, et al. Drug susceptibility in HIV infection after viral rebound in patients receiving indinavir-containing regimens. JAMA 2000, 283:229-234.
8. Duval X, Lamotte C, Race E, Descamps D, Damond F, Clavel F, et al. Amprenavir inhibitory quotient and virological response in human immunodeficiency virus-infected patients on an amprenavir-containing salvage regimen without or with ritonavir. Antimicrob Agents Chemother 2002, 46:570-574.
9. Condra JH, Gabryelski LJ, Graham DJ, Quintero JC, Schlief WA, Blahy OM, et al. In vivo emergence of HIV-1 variants resistant to multiple protease inhibitors. Nature 1995, 375:569-571.
10. Molla A, Korneyeva M, Gao Q, Vasavanonda S, Schipper PJ, Mo HM, et al. Ordered accumulation of mutations in HIV protease confers resistance to ritonavir. Nature Med 1996, 2:760-766.
11. Boden D, Markowitz M. Resistance to human immunodeficiency virus type 1 protease inhibitors. Antimicrob Agents Chemother 1998, 42:2775-2783.
12. Cabana M, Clotet B, Martinez MA. Emergence and genetic evolution of HIV-1 variants with mutations conferring resistance to multiple reverse transcriptase and protease inhibitors. J Med Virol 1999, 59:480-490.
13. Casado JL, Dronda F, Hertogs K, Antela A, Moreno S. Failure of a ritonavir plus saquinavir-based rescue regimen precludes the use of protease inhibitors. AIDS 2000, 14:466-468.
14. Deeks SG, Grant RM, Beatty GW, Hortoan C, Detmer J, Eastman S. Activity of a ritonavir plus saquinavir-containing regimen in patients with virologic evidence of indinavir or ritonavir failure. AIDS 1998, 12:F97-102.
15. Deeks SG, Hellmann NS, Grant RM, Parkin NT, Petropoulos CJ, Becker M, et al. Novel four-drug salvage treatment regimens after failure of a human immunodeficiency virus type 1 protease inhibitor-containing regimen: antiviral activity and correlation of baseline phenotypic drug susceptibility with virologic outcome. J Infect Dis 1999, 179:1375-1381.
16. Fätkenheuer G, Hoetelmans RMW, Hunn N, Schwenk A, Franzen C, Reiser M, et al. Salvage therapy with regimens containing ritonavir and saquinavir in extensively pretreated HIV-infected patients. AIDS 1999, 13:1485-1489.
17. Piketty C, Race E, Castiel P, Belec L, Peytavin G, Si-Mohamed A, et al. Efficacy of a five-drug combination including ritonavir, saquinavir and efavirenz in patients who failed on a conventional triple-drug regimen: phenotypic resistance to protease inhibitors predicts outcome of therapy. AIDS 1999, 13:F71-F77.
18. Harrigan PR, Hertogs K, Verbiest W, Pauwels B, Larder S, Kemp S, et al. Baseline HIV drug resistance profile predicts response to ritonavir-saquinavir protease inhibitor therapy in a community setting. AIDS 1999, 13:1863-1871.
19. Condra JH, Holder DJ, Schleif WA, Blahy OM, Danovich RM, Gabryelski LJ, et al. Genetic correlates of in vivo viral resistance to indinavir, a human immunodeficiency virus type 1 protease inhibitor. J Virol 1996, 70:8270-8276.
20. Condra JH, Petropoulos CJ, Ziermann R, Schleif WA, Shivaprakash R, Emini EA. Drug resistance and predicted virologic responses to human immunodeficiency virus type 1 protease inhibitor therapy. J Infect Dis 2000, 182:758-765.
21. Kempf DJ, Isaacson JD, King MS, Brun SC, Xu Y, Real K, et al. Identification of genotypic changes in human immunodeficiency virus protease that correlate with reduced susceptibility to the protease inhibitor lopinavir among viral isolates from protease inhibitor-experienced patients. J Virol 2001, 75:7462-7469.
22. Buss N, Snell P, Bock J, Hsu A, Jorga K. Saquinavir and ritonavir pharmacokinetics following combined ritonavir and saquinavir (soft gelatin capsules) administration. Br J Clin Pharmacol 2001, 52:255-264.
23. Hsu A, Granneman GR, Cao G, Carothers L, Japour A, El-Shourbagy T, et al. Pharmacokinetic interaction between ritonavir and indinavir in healthy volunteers. Antimicrob Agents Chemother 1998, 42:2784-2791.
24. Merry C, Barry MG, Mulcahy F, Ryan M, Heavey J, Tija JF, et al. Saquinavir pharmacokinetics alone and in combination with ritonavir in HIV-infected patients. AIDS 1997, 11:F29-F33.
25. Piscitelli S, Bechtel C, Sadler B, Falloon J. The addition of a second protease inhibitor eliminates amprenavir-efavirenz drug interactions and increases plasma amprenavir concentrations. Seventh Conference on Retroviruses and Opportunistic Infections. San Francisco, January 2000 [abstract 78].
26. Saah AJ, Winchell GA, Nessly ML, Seniuk MA, Rhodes RR, Deutsch PJ. Pharmacokinetic profile and tolerability of indinavir-ritonavir combinations in healthy volunteers. Antimicrob Agents Chemother 2001, 45:2710-2715.
27. Sham HL, Kempf DJ, Molla A, Marsh KC, Kumar GN, Chen CM, et al. ABT-378, a highly potent inhibitor of the human immunodeficiency virus protease. Antimicrob Agents Chemother 1998, 42:3218-3224.
28. Parkin NT, Lie YS, Hellmann NS, et al. Phenotypic changes in drug susceptibility associated with failure of human immunodeficiency virus type 1 (HIV-1) triple combination therapy. J Infect Dis 1999, 180:865-870.
29. Petropoulos CJ, Parkin NT, Limoli KL, Lie YS, Wrin T, Huang W, et al. A novel phenotypic drug susceptibility assay for human immunodeficiency virus type 1. Antimicrob Agents Chemother 2000, 44:920-928.
30. Karmochkine M, Mohamed AS, Piketty C, Ginsburg C, Raguin G, Schneider-Fauveau V, et al. The cumulative occurrence of resistance mutations in the HIV-1 protease gene is associated with failure of salvage therapy with ritonavir and saquinavir in protease inhibitor-experienced patients. Antiviral Res 2000, 47:179-188.
31. Walter H, Schmidt B, Rascu A, Helm M, Moschik B, Paatz C, et al. Phenotypic HIV-1 resistance correlates with treatment outcome of nelfinavir salvage therapy. Antiviral Ther 2000, 5:249-256.
32. Perez-Flias MJ, Lanier R, Munoz V, Garcia-Arata I, Cassado JL, Marti-Belda P, et al. Phenotypic testing predicts virological response in successive protease inhibitor-based regimens. AIDS 2000, 14:F95-F101.
33. Casado JL, Dronda F, Hertogs K, Sabido R, Antela A, Marti-Belda P, et al. Efficacy, tolerance, and pharmacokinetics of the combination of stavudine, nevirapine, nelfinavir, and saquinavir as salvage regimen after ritonavir or indinavir failure. AIDS Res Human Retroviruses 2001, 17:93-98.
34. Zolopa AR, Shafer RW, Warford A, Montoya JG, Hsu P, Katzenstein DA, et al. HIV-1 genotypic resistance patterns predict response to saquinavir-ritonavir therapy in patients in whom previous protease inhibitor therapy had failed. Ann Intern Med 1999, 131:813-821.
35. Lawrence J, Schapiro J, Winters M, Montoya J, Zolopa A, Pesano R, et al. Clinical resistance patterns and response to two sequential protease inhibitor regimens in saquinavir and reverse transcriptase inhibitor-experienced patients. J Infect Dis 1999, 179:1356-1364.
36. Para MF, Glidden DV, Coombs RW, Collier AC, Condra JH, Craig C, et al. Baseline human immunodeficiency virus type 1 phenotype, genotype, and RNA response after switching from long-term hard-capsule saquinavir to indinavir or soft-gel-capsule saquinavir in AIDS Clinical Trials Group protocol 333. J Infect Dis 2000, 182:733-743.
37. Durant J, Clevenbergh P, Halfon P, Delgiudice P, Porsin S, Simonet P, et al. Drug-resistance genotyping in HIV-1 therapy: the VIRADAPT randomised controlled trial. Lancet 1999, 353:2195-2199.
38. Baxter JD, Mayers DL, Wentworth DN, Neaton JD, Hoover ML, Winters MA, et al. A randomized study of antiretroviral management based on plasma genotypic antiretroviral resistance testing in patients failing therapy. CPCRA 046 Study Team for the Terry Beirn Community Programs for Clinical Research on AIDS. AIDS 2000, 14:F83-F93.
39. Clevenbergh P, Durant J, Halfon P, del Giudice P, Mondain V, Montagne N, et al. Persisting long-term benefit of genotype-guided treatment for HIV-infected patients failing HAART. The Viradapt Study: week 48 follow-up. Antiviral Ther 2000, 5:65-70.
40. Cohen CJ, Hunt S, Sension M, Farthing C, Conant M, Jacobson S, et al. A randomized trial assessing the impact of phenotypic resistance testing on antiretroviral therapy. AIDS 2002, 16:579-588.
41. Bangsberg DR, Hecht FM, Charlebois ED, Zolopa AR, Holodniy M, Sheiner L, et al. Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS 2000, 14:357-366.
42. Benson CA, Deeks SG, Brun SC, Gulick RM, Eron JJ, Kessler HA, et al. Safety and antiviral activity at 48 weeks of lopinavir/ritonavir plus nevirapine and 2 nucleoside reverse-transcriptase inhibitors in human immunodeficiency virus type 1-infected protease inhibitor-experienced patients. J Infect Dis 2002, 185:599-607.
43. Liechty C, Alexander C, Harrigan R, et al. Are random antiretroviral drug levels associated with objectively measured adherence behavior? Tenth Conference on Retroviruses and Opportunistic Infections. Boston, MA 2003. [abstract 529].