Dual protease inhibitor therapy in the management of the HIV-1

Expert Opinion on Pharmacotherapy

Volumn 1, Issue 7, 2000, Pages 1331-1342

  Yu, Kalvin ^a   Daar, Eric S ^a  

^a CEDARS SINAI MEDICAL CENTER   (United States)

Author keywords

Amprenavir; Antiretroviral therapy; Dual protease inhibitor; HIV; Indinavir; Lopinavir; Nelfmavir; Phannacokinetics; Ritonavir; Saquinavir

Indexed keywords

PROTEINASE INHIBITOR;

BLOOD; DRUG COMBINATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; REVIEW; VIROLOGY;

DRUG COMBINATIONS; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS;

EID: 0034573192     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.1.7.1331     Document Type: Article

References (50)

1. EGGER M, HIRSCHEL B, FRANCIOLI P et al.: Impact of new antiretroviral combination therapies in HIV infected patients in Switzerland: prospective multicentre study. Br. Mcd.J. (1997) 315:1194-1199. Article describing the impact protease therapy has had on morbidity and mortality.
2. HARRIS M, DURAKOVIC C, RAE S et al.: Virologie response to indinavir/nevirapine/3TC correlates with indinavir trough concentrations. 37th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Canada (September 28 - October 1 1997). Abstract 1-173. Article describing the importance of PI trough levels in virologie response.
3. ACOSTA EP, HENRY K, WELLER D et al.: Indinavir pharmacokinetics and relationships between exposure and antiviral effect. 37th Interscience Conference on Antimicrobial Agents and Chemotherapy. Toronto, Canada (September 28 - October 1 1997). Abstract A-15.
4. CHIBA M, HENSLEIGH M, NISÉIME JA, BALAN1SK, LIN JH: Role of cytochrome P450 3A4 in human metabolism of MK-639, a potent human immunodeficiency virus protease inhibitor. Drug Metab. & Dispos. (1996) 24:307-314.
5. PISCITELLI SC, FLEXNER C, MINOR JR, POLIS MA, MASUR H: Drug interactions in patients infected with human immunodeficiency virus. Clin. Infect. Dis. (1996) 23:685-693. Article summarising drug-drug interactions in HIV-infected persons.
6. FITZSIMMONS ME, COLLINS JM: Selective biotransformation of the human immunodeficiency virus protease inhibitor saquinavir by human smallintestinal cytochrome P4503A4: potential contribution to high first-pass metabolism. Drug Metab. & Dispos. (1997) 25:256-266.
7. MERRILL DP, MANION DJ, CHOU TC, HIRSCH MS: Antagonism between human immunodeficiency virus type 1 protease inhibitors indinavir and saquinavir in vitro. ]. Infect. Dis. (1997) 176:265-268.
8. UNDER MV, PROUGH RA, VALDES R, Jr.: Pharmacogenetics: a laboratory tool for optimizing therapeutic efficiency. Clin. Chem. (1997) 43:254-266.
9. HSU A, GRANNEMAN GR, CAO G et al.: Pharmacokinetic interactions between two human immunodeficiency virus protease inhibitors, ritonavir and saquinavir. Clin. Pharmacol. Ther. (1998) 63:453-464.
10. CAMERON DV, JAPOUR AJ, XU Y et al: Ritonavir and saquinavir combination therapy for treatment of HIV infection. A1DS(1999) 13:213-224.
11. CAMERON DV, XU Y, RODE R et al.: Three-year follow-up and conditional outcome survival analysis of ritonavir (RTV) plus saquinavir (SQV) therapy in HIV Infection. 7th Conference on Retrovimses and Opportunistic Infections. San Francisco, CA, USA (January 30 - February 2 2000). Abstract 533. Abstract describing durable virologie response using dual PI therapy.
12. MOLLA A, CHERNYAVSKIY T, VASAVANONDA S et al.-. Synergistic anti-HIV activity of ritonavir and other protease inhibitors in the presence of human serum. XllInternational Conference on AIDS. Geneva, Switzerland 0une 28 -July 3 1998). Abstract 12315.
13. KIRK, O, KATZENSTEIN TL, GERSTOFT J et al: Combination therapy containing ritonavir plus saquinavir has superior short-term antiretroviral efficacy: a randomized trial. AIDS (1999) 13:F9-l6. One of few studies that compared efficacy of dual to mono PI therapy-containing regimens.
14. GISOLF EH, JURRIAANS S, PELGROM J et al.: The effect of treatment intensification in HIV-infection: a study comparing treatment with ritonavir/saquinavir and ritonavir/saquinavir/stavudine. Prometheus Study Group. AIDS(2QOQ) 14:40513. A study that demonstrates viral suppression in a substantial number of individuals treated with dual PI therapy alone, as well as the ability to intensify such a regimen with reverse transcriptase inhibitors.
15. GULICK RM, MELLORS JV, HAVLIR D et al: Treatment with indinavir, zidovudine and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. A'. Engl J. Med. (1997) 337:734-739. Article describing pivotal study that demonstrated the potency of Pi-containing antiretroviral therapy.
16. SAAG MS, KILBY M, EHRENSING E et al: Saquinavir systemic exposure and safety of once daily administration of Fortovase (Saquinavir) soft gel capsule (FTV) in combination with low-dose ritonavir (RTV). 39th Intersciencc Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA, USA (September 26 - 29 1999). Abstract 330.
17. VAN HEESWIJK RPG, VELDKAMP AI, MULDER JV et al.: Once-daily dosing of saquinavir and low-dose ritonavir in HIV-1-infected individuals: a pharmacokinetic pilot study. AIDS(2000) 14:F103-110.
18. LALLEMAND F, ADDA N, SCHNEIDER V, JACOMET C, SALHI Y, ROZENBAUM V: Prospective follow-up of 67 indinavir-experienced human immunodeficiency virus-infected and AIDS patients treated with ritonavir/saquinavir combination, din. Infect. Dis. (1999)28:1184-1185.
19. HALL CS, RAINES CP, BARNETT SH, MOORE RD, GALLANT JE: Efficacy of salvage therapy containing ritonavir and saquinavir after failure of single protease inhibitorcontaining regimens. /tffi>5(1999) 13:1207-1212.
20. TEBAS P, PATICK AK, KANE EM et al.: Virologie responses to a ritonavir-saquinavir-containing regimen in patients who had previously failed nelfinavir. ,4705(1999) 13:F23-F28.
21. ZOLOPA A, TEBAS P, GALLANT J et al.: The efficacy of ritonavir (RTV)/saquinavir (SQV) antiretroviral therapy (ART) in patients who failed nelfinavir (NFV): A multi
22. HSU A, GRANNEMAN R, HEATH-CHIOZZI M et ah. Indinavir can be taken with regular meals when administered with ritonavir. XII International Conference on AIDS. Geneva, Switzerland (June 28 -July 3 1998). Abstract 22301.
23. ROCKSTROH JK, BERGMANN F, WIESEL V et al.: Efficacy and safety of twice daily first-line ritonavir/Indinavir plus double nucleoside combination therapy in HIV-infected individuals. AIDS (.2000) 14:1181-1185.
24. VAN HEESWIJK RP, VELDKAMP AI, HOETELMANS RM et al.: The steady-state plasma pharmacokinetics of indinavir alone and hi combination with a low dose of ritonavir in twice daily dosing regimens in HTV-1infected individuals. AIDSW99) 13:F95-99. Article demonstrating the ability of ritonavir added to indinavir to enhance indinavir pharmacokinetics and overcome drug-food interactions.
25. SAAH A, WINCHELL GSENIUK M, NESSLY M, DEUTSCH P: Multiple-dose pharmacokinetics (PK) and tolerability of indinavir (IDV) and ritonavir (RTV) combinations in a once-daily regimen in healthy volunteers (Merck 089). 39th Intersciencc Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA, USA (September 26 29 1999). Abstract 329.
26. BURGER DM, HUGEN.PWH, TER HOFSTEDE HJM et al.: Dose-finding study of a once dally indinavir/ritonavir regimen in healthy volunteers. 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA, USA (September 26 - 291999). Abstract 321.
27. SHULMAN N, ZOLOPA A, HAVLIR D et al.: Ritonavir intensification in indinavir treated patients with detectable HIV RNA levels. 7th Conference on Retrovintses and Opportunistic Infections. San Francisco, CA, USA (January 30 - February 4 2000). Abstract 534.
28. HSU A, GRANNEMAN R, MOLLA A et al.: Ritonavircontaining dual protease inhibitor regimens may have synergistic antiviral effects in patients-based on in vitro model. XII International Conference on AIDS. Geneva, Switzerland (June 28 -July 31998). Abstract 22350.
29. FLEXNER C, HSU A, KERR B et al.: Steady-state pharmacokinetic interactions between ritonavir (RTV), nelfinavir (NFV) and the nelfinavir active metabolite M8 (AG1402). XII International Conference on AIDS. Geneva, Switzerland (June 28 -July 31998). Abstract 42265.
30. GALLANT JE, RAINES C, SUN E et al.: A Phase H study of ritonavir-nelfinavir combination therapy: 48-week data. 6th Conference on Retrovimses and Opportunistic Infections. Chicago, IL, USA (January 31 - February 4 1999). Abstract 393.
31. PRO10022: A study to investigate the degree of pharmacokinetic interaction between amprenavir and ritonavir (450 mg b.i.d., 100 mg b.Ld.) following co-administration to healthy subjects. Data on File at Glaxo Wellcome.
32. SADLER BM, PILIERO PJ, PRESTON SL, YU L, STEIN DS: Pharmacokinetic (PK) drug-interaction between amprenavir (APV) and ritonavir (RTV) in HTV-seronegative subjects after multiple oral dosing. 7th Conference on Retrovinises and Opportunistic Infections. San Francisco, CA, USA (January 30 - February 2 2000). Abstract 77.
33. PISCITELLI S, BECHTEL C, SADLER S, FALLOON J: The addition of a second protease inhibitor eliminates amprenavir-efavirenz drug interactions and increases plasma amprenavir concentrations. 7th Conference on Retrovinises and Opportunistic Infections. San Francisco, CA, USA (January 30 - February 2 2000). Abstract 78.40.
34. BERTZ R, LAM W, BRUN S et al: Multiple-dose pharmacokinetics (PK) of ABT-378/ritonavir (ABT-378/r) in HIV+ subjects. 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA, USA (September 26 - 29 1999). Abstract 327.
35. GULICK R, KING M, BLUN S et al.: ABT-378/ritonavir (ABT-378/r) in antiretroviral-naive HIV+ patients: 72 weeks. 7th Conference on Retrovimses and Opportunistic Infections. San Francisco, CA, USA (January 30 - February 2 2000). Abstract 515.
36. DEEKS S, BRUN S, XU Y et al.: ABT-378/ritonavir (ABT-378/r) suppresses fflV RNA to < 400 copies/ml in 84% of patients at 48 weeks. 7th Conference on Retrovinises and Opportunistic Infections. San Francisco, CA, USA (January 30 - February 2 2000). Abstract 532. Abstract describing the ability of a new PI regimen to suppress virus in Pi-experienced patients.
37. KEMPF D, XU Y, BRUN S et al.: Baseline genotype and phenotype do not predict response to ABT-378/ritonavir in Pi-experienced patients at 24 and 48 weeks. 7th Conference on Retrovinises and Opportunistic Infections. San Francisco, CA, USA (January 30 February 4 2000). Abstract 731. Abstract demonstrating that the response to a new PI is independent of phenotypic susceptibility.
38. MERRY C, BARRY MG, MULCAHY F, HALIFAX KL, BACK DJ: Saquinavir pharmacokinetics alone and in combination with nelfinavir in HIV-infected patients. AIDSW97) 11:F117-F120.
39. MOYLE G, POZNIAK A, OPRAVIL M et dl.: The SPICE study: 48-week activity of combinations of saquinavir soft gelatin and nelfinavir with and without nuclcoside analogues. Study of protease inhibitor combinations in Europe. J. Acqnir. Immune Deficiency Syndr. (2000) 23:128-137.
40. CLARK R, CURRIER JS, GREIGER P et al.: Efficacy and safety of BID and TID regimens of nelfinavir (NFV) + saquinavir (SQV) + stavudine (d4T) + lamivudïne (3TC) in HIV-infected women: 48 week results of the Women's First Study. 39tb Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA, USA (September 26 - 29 1999). Abstract 1988.
41. ROCKSTROH JK, ALTFELD M, KUPFER B et al: Failure of double protease inhibitor therapy as a salvage therapy for HIV-infected patients resistant to conventional triple therapy. Eitr.J. Med. Res. (1999) 4:271-274.
42. KRAVCIK S, VICTOR G, ANGEL JB, BADLEY AD, GARBER GE, CAMERON DV: Activity of the combination of nelfinavir and saquinavir against human immunodeficiency virus after failure of prior protease inhibitors. Clin. Infect. Dis. (1999) 29:702-703.
43. SQUIRES K, RIDDLER S, HAVLIR D et al.: Co-administration of indinavir (IDV) 1200 nig with nelfinavir (NFV) 1250 mg in a twice dally regimen: preliminary safety PK activity. 6th Conference on Retroviniscs and Opportunistic Infections. Chicago, IL, USA (January 31 - February 4 1999). Abstract 364.
44. CHONG K-T, PAGANO PJ: In vitro combination of PNU-140Ö90, a human immunodeficiency virus type 1 protease inhibitor, with ritonavir against ritonavirsensitive and -resistant clinical isolates. Antiniicrob. Agents Cbcmotber. (1997) 41:2367-2373.
45. BALDWIN JR, BORIN MT, FERRY JJ ct al.: Pharmacokinetics (PK) interaction between the HIV protease inhibitors tipranavir and ritonavir. 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA, USA (September 26 - 29 1999). Abstract 657.
46. HAMMER S, MELLORS J, VAIDA F et al.: A randomized, placebo-controlled trial of saquinavir (SQV), indinavir (IDV), or nelfinavir (NFV) in combination with amprenavir (APV), abacavir (ABC), efavirenz (EFZ), adefovir (ADV) hi patients with protease inhibitor (PI) failure. 7th Conference on Retrovintses and Opportunistic Infections. San Francisco, CA, USA (January 30 - February 4 2000) Abstract LB7. Abstract reporting the results of a randomised study demonstrating that dual PI therapy may be an important component of anliretroviral salvage regimens.
47. DANNER SA, CARR A, LEONARD JM et al.: A short-term study of the safety, pharmacokinetics and efficacy of ritonavir, an inhibitor of HIV-1 protease. EuropeanAustralian Collaborative Ritonavir Study Group. A'.Engl.J. Med. (1995) 333:1528-1533-
48. ACOSTA EP, HENRY K, BAKEN L, PAGE LM, FLETCHER CV: Indinavir concentrations and antiviral effect. Phannacotherapy(.iy)
49. MARKOWITZ M, CONANT M, HURLEY A et al: A preliminary evaluation of nelfinavir mesylate, an inhibitor of human immunodeficiency virus (HIV)-1 protease, to treat HIV infection./ Infect. Dis. (1998) 177:1533-1540.
50. ROCKSTROH JK, BERGMANN F, WIESEL V, RIEKE A, NADLER M, KNECHTEN H: Efficacy and safety of b.Ld. firstline ritonavir/indinavir plus double nucleoside combination therapy in HIV-infected individuals. 38th Interscience Conference on Antimicrobial Agents and Chemotherapy (September 24 - 27 1998). Abstract 1-213.