Effect of lopinavir/ritonavir monotherapy on quality of life and self-reported symptoms among antiretroviral-naive patients: Results of the MONARK trial

Antiviral Therapy

Volumn 13, Issue 4, 2008, Pages 591-599

  Spire, Bruno ^a,b,c   Marcellin, Fabienne ^a,b,c   Cohen Codar, Isabelle ^d   Flandre, Philippe ^a   Boue, Francois ^e   Dellamonica, Pierre ^f   Raffi, François ^g   Norton, Michael ^h   Ngo Van, Philippe ^d   Delfraissy, Jean François ⁱ  

^a INSERM   (France)

^b AIX MARSEILLE UNIVERSITY   (France)

^c OBSERVATOIRE RÉGIONAL DE LA SANTÉ PROVENCE ALPES CÔTE D AZUR   (France)

^d Abbott   (France)

^e HÔPITAL ANTOINE BÉCLÈRE   (France)

^f CENTRE HOSPITALIER UNIVERSITAIRE DE NICE   (France)

^g HÔTEL DIEU   (France)

^h ABBOTT LABORATORIES   (United States)

ⁱ BICÊTRE HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; VIRUS RNA; ZIDOVUDINE;

ANOREXIA; ANXIETY; ARTHRALGIA; ARTICLE; BACKACHE; BLOATING; CHILL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DEPRESSION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRY SKIN; DYSPNEA; DYSURIA; FATIGUE; FEVER; FLANK PAIN; FOOT PARESTHESIA; HAIR LOSS; HAND PARESTHESIA; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LIPID STORAGE; LOW BACK PAIN; MAJOR CLINICAL STUDY; MEMORY DISORDER; MONOTHERAPY; MORBIDITY; MULTICENTER STUDY; MYALGIA; NAUSEA; NERVOUSNESS; PAIN; PARESTHESIA; PATIENT SATISFACTION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; SCORING SYSTEM; SELF REPORT; SEXUAL DYSFUNCTION; SIDE EFFECT; SKIN TINGLING; SLEEP DISORDER; STOMACH DISCOMFORT; STOMACH GAS; STOMACH PAIN; STRUCTURED QUESTIONNAIRE; SWEATING; TASTE DISORDER; TREATMENT RESPONSE; VIRUS LOAD; VOMITING; WASTING SYNDROME; WEIGHT GAIN; WEIGHT REDUCTION;

ANTI-HIV AGENTS; DRUG THERAPY, COMBINATION; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; LAMIVUDINE; PYRIMIDINONES; QUALITY OF LIFE; REVERSE TRANSCRIPTASE INHIBITORS; RITONAVIR; TREATMENT OUTCOME; VIRAL LOAD; ZIDOVUDINE;

EID: 47649103869     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (35)

1. Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet 2000; 356:1423-1430.
2. Fellay J, Boubaker K, Ledergerber B, et al. Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study. Lancet 2001; 358:1322-1327.
3. Bonfanti P, Valsecchi L, Parazzini F, et al. Incidence of adverse reactions in HIV patients treated with protease inhibitors: a cohort study. Coordinamento Italiano Studio Allergia e Infezione da HIV (CISAI) Group. J Acquir Immune Defic Syndr 2000; 23:236-245.
4. Duval X, Journot V, Leport C, et al. Incidence of and risk factors for adverse drug reactions in a prospective cohort of HIV-infected adults initiating protease inhibitor-containing therapy. Clin Infect Dis 2004; 39:248-255.
5. Rajagopalan Rea. Impact of lipoatrophy on quality of life in HIV-infected individuals receiving antiretroviral therapy (ART). 9th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. 19-21 July 2007, Sydney, Australia 2007.
6. Blanch J, Rousaud A, Martinez E, De, et al. Impact of lipodystrophy on the quality of life of HIV-1-infected patients. J Acquir Immune Defic Syndr 2002; 31:404-407.
7. Delfraissy JF, Flandre P, Delaugerre C, et al. MONARK trial (MONotherapy AntiRetroviral Kaletra): 48-week analysis of lopinavir/ritonavir (LPV/r) monotherapy compared to LPV/r+zidovudine/lamivudine (AZT/3TC) in antiretroviral-naive Patients. XVI International AIDS Conference. 13-18 August 2006, Toronto, Canada.
8. Delfraissy JF, Flandre P, Delaugerre C, et al. Lopinavir/ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients. AIDS 2008; 22:385-393.
9. WHOQOL-HIVGroup. WHOQOL-HIV for quality of life assessment among people living with HIV and AIDS: results from the field test. AIDS Care 2004; 16:882-889.
10. Préau M, Apostolidis T, François C, Raffi F, Spire B. Time perspective and quality of life among HIV-infected patients in the context of HAART. AIDS Care 2007; 19:449-458.
11. Justice AC, Holmes W, Gifford AL, et al. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol 2001; 54 Suppl 1:S77-S90.
12. Carrieri P, Spire B, Duran S, et al. Health-related quality of life after 1 year of highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2003; 32:38-47.
13. Protopopescu C, Marcellin F, Spire B, et al. Health-related quality of life in HIV-1-infected patients on HAART: a five-year longitudinal analysis accounting for dropout in the APROCO-COPILOTE cohort (ANRS CO8). Qual Life Res 2007; 16:577-591.
14. Nieuwkerk PT, Gisolf EH, Colebunders R, Wu AW, Danner SA, Sprangers MA. Quality of life in asymptomatic- and symptomatic HIV infected patients in a trial of ritonavir/saquinavir therapy. The Prometheus Study Group. AIDS 2000; 14:181-187.
15. Cohen C, Revicki DA, Nabulsi A, Sarocco PW, Jiang P. A randomized trial of the effect of ritonavir in maintaining quality of life in advanced HIV disease. Advanced HIV Disease Ritonavir Study Group. AIDS 1998; 12:1495-1502.
16. Carr A, Chuah J, Hudson J, et al. A randomised, open-label comparison of three highly active antiretroviral therapy regimens including two nucleoside analogues and indinavir for previously untreated HIV-1 infection: the OzCombo1 study. AIDS 2000; 14:1171-1180.
17. Mannheimer SB, Matts J, Telzak E, et al. Quality of life in HIV-infected individuals receiving antiretroviral therapy is related to adherence. AIDS Care 2005; 17:10-22.
18. Ware JE, Jr., Sherbourne CD. The MOS 36-item short-form health survey (SF-36) I. Conceptual framework and item selection. Med Care 1992; 30:473-483.
19. Wu AW, Revicki DA, Jacobson D, Malitz FE. Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Qual Life Res 1997; 6:481-493.
20. Wu AW, Hays RD, Kelly S, Malitz F, Bozzette SA. Applications of the Medical Outcomes Study health-related quality of life measures in HIV/AIDS. Qual Life Res 1997; 6:531-554.
21. Wu AW, Huang IC, Gifford AL, Spritzer KL, Bozzette SA, Hays RD. Creating a crosswalk to estimate AIDS Clinical Trials Group quality of life scores in a nationally representative sample of persons in care for HIV in the United States. HIV Clin Trials 2005; 6:147-157.
22. Casado A, Badia X, Consiglio E, et al. Health-related quality of life in HIV-infected naive patients treated with nelfinavir or nevirapine associated with ZDV/3TC (the COMBINE-QOL substudy). HIV Clin Trials 2004; 5:132-139.
23. Duran S, Spire B, Raffi F, et al. Self-reported symptoms after initiation of a protease inhibitor in HIV-infected patients and their impact on adherence to HAART. HIV Clin Trials 2001; 2:38-45.
24. Duran S, Saves M, Spire B, et al. Failure to maintain long-term adherence to highly active antiretroviral therapy: the role of lipodystrophy. AIDS 2001; 15:2441-2444.
25. Ammassari A, Murri R, Pezzotti P, et al. Self-reported symptoms and medication side effects influence adherence to highly active antiretroviral therapy in persons with HIV infection. J Acquir Immune Defic Syndr 2001; 28:445-449.
26. Carried MP, Leport C, Protopopescu C, et al. Factors associated with nonadherence to highly active antiretroviral therapy: a 5-year follow-up analysis with correction for the bias induced by missing data in the treatment maintenance phase. J Acquir Immune Defic Syndr 2006; 41:477-485.
27. Preau M, Leport C, Salmon-Ceron D, et al. Health-related quality of life and patient-provider relationships in HIV-infected patients during the first three years after starting PI-containing antiretroviral treatment. AIDS Care 2004; 6:649-661.
28. Vincent E, Bouhnik AD, Carrieri MP, et al. Impact of HAART-related side effects on unsafe sexual behaviours in HIV-infected injecting drug users: 7-year follow up. AIDS 2004; 18:1321-1325.
29. Chassany O, Sagnier P, Marquis P, Fullerton S, Aaronson N. Patient-reported outcomes: the example of health-related quality of life - a european guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Inf J 2002; 36:209-238.
30. Lesho EP, Gey DC. Managing issues related to antiretroviral therapy. Am Fam Physician 2003; 68:675-686.
31. Shibuyama S, Gevorkyan A, Yoo U, Tim S, Dzhangiryan K, Scott JD. Understanding and avoiding antiretroviral adverse events. Curr Pharm Des 2006; 12:1075-1090.
32. Rachlis A, Fanning MM. Zidovudine toxicity. Clinical features and management. Drug Saf 1993; 8:312-320.
33. Arribas JR, Pulido F, Delgado R, et al. Lopinavir/ritonavir as single-drug therapy for maintenance of HIV-1 viral suppression: 48-week results of a randomized, controlled, open-label, proof-of-concept pilot clinical trial (OK Study). J Acquir Immune Defic Syndr 2005; 40:280-287.
34. Pulido F, Arribas JR, Delgado R, et al. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV. AIDS 2008; 22:F1-F9.
35. Clayson DJ, Wild DJ, Quarterman P, Duprat-Lomon I, Kubin M, Coons SJ. A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials. Pharmacoeconomics 2006; 24:751-765.