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Lopinavir/ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients.
AIDS. 2008 Jan 30; 22(3):385-93.AIDS

Abstract

BACKGROUND

Guidelines for the use of antiretroviral agents for HIV-1 infection recommend combining at least three agents. The toxicity, cost, and complexity of such regimens warrant the search for other options.

METHODS

MONARK is a prospective, open-label, randomized, 96-week trial comparing the safety and efficacy of lopinavir/ritonavir monotherapy with a standard lopinavir/ritonavir plus zidovudine and lamivudine regimen as an initial treatment regimen in HIV-infected patients with HIV-RNA levels less than 100,000 copies/ml. The primary endpoint was the proportion of patients with HIV-1-RNA levels below 400 copies/ml at week 24 and below 50 copies/ml at week 48.

RESULTS

Eight-three and 53 patients were randomly assigned and exposed in the monotherapy and triple-drug groups, respectively. At week 48, by an intent-to-treat analysis, 53 of 83 patients (64%) in the monotherapy group and 40 of 53 patients (75%) in the triple-drug group achieved the primary endpoint (P = 0.19). The on-treatment analysis indicates that 80 and 95% of patients reached the primary endpoint in the monotherapy and triple-drug groups, respectively (P = 0.02). In the monotherapy arm, protease inhibitor-associated resistance mutations were seen in three of the 21 patients qualifying for genotypic resistance testing, with a modest impact on lopinavir susceptibility. None of the serious reported adverse events were considered to be related to study treatment.

CONCLUSION

Our results suggest that lopinavir/ritonavir monotherapy demonstrates lower rates of virological suppression when compared with lopinavir/ritonavir triple therapy and therefore should not be considered as a preferred treatment option for widespread use in antiretroviral-naive patients.

Authors+Show Affiliations

AP-HP, Department of Internal Medicine and Infectious Diseases, Bicetre University Hospital, Le Kremlin-Bicêtre, France. jean-francois.delfraissy@bct.aphp.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

18195565

Citation

Delfraissy, Jean-François, et al. "Lopinavir/ritonavir Monotherapy or Plus Zidovudine and Lamivudine in Antiretroviral-naive HIV-infected Patients." AIDS (London, England), vol. 22, no. 3, 2008, pp. 385-93.
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(3):385-93.
Delfraissy, J. F., Flandre, P., Delaugerre, C., Ghosn, J., Horban, A., Girard, P. M., Norton, M., Rouzioux, C., Taburet, A. M., Cohen-Codar, I., Van, P. N., & Chauvin, J. P. (2008). Lopinavir/ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients. AIDS (London, England), 22(3), 385-93. https://doi.org/10.1097/QAD.0b013e3282f3f16d
Delfraissy JF, et al. Lopinavir/ritonavir Monotherapy or Plus Zidovudine and Lamivudine in Antiretroviral-naive HIV-infected Patients. AIDS. 2008 Jan 30;22(3):385-93. PubMed PMID: 18195565.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lopinavir/ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients. AU - Delfraissy,Jean-François, AU - Flandre,Philippe, AU - Delaugerre,Constance, AU - Ghosn,Jade, AU - Horban,Andrzej, AU - Girard,Pierre-Marie, AU - Norton,Michael, AU - Rouzioux,Christine, AU - Taburet,Anne-Marie, AU - Cohen-Codar,Isabelle, AU - Van,Philippe Ngo, AU - Chauvin,Jean-Pierre, PY - 2008/1/16/pubmed PY - 2008/1/30/medline PY - 2008/1/16/entrez SP - 385 EP - 93 JF - AIDS (London, England) JO - AIDS VL - 22 IS - 3 N2 - BACKGROUND: Guidelines for the use of antiretroviral agents for HIV-1 infection recommend combining at least three agents. The toxicity, cost, and complexity of such regimens warrant the search for other options. METHODS: MONARK is a prospective, open-label, randomized, 96-week trial comparing the safety and efficacy of lopinavir/ritonavir monotherapy with a standard lopinavir/ritonavir plus zidovudine and lamivudine regimen as an initial treatment regimen in HIV-infected patients with HIV-RNA levels less than 100,000 copies/ml. The primary endpoint was the proportion of patients with HIV-1-RNA levels below 400 copies/ml at week 24 and below 50 copies/ml at week 48. RESULTS: Eight-three and 53 patients were randomly assigned and exposed in the monotherapy and triple-drug groups, respectively. At week 48, by an intent-to-treat analysis, 53 of 83 patients (64%) in the monotherapy group and 40 of 53 patients (75%) in the triple-drug group achieved the primary endpoint (P = 0.19). The on-treatment analysis indicates that 80 and 95% of patients reached the primary endpoint in the monotherapy and triple-drug groups, respectively (P = 0.02). In the monotherapy arm, protease inhibitor-associated resistance mutations were seen in three of the 21 patients qualifying for genotypic resistance testing, with a modest impact on lopinavir susceptibility. None of the serious reported adverse events were considered to be related to study treatment. CONCLUSION: Our results suggest that lopinavir/ritonavir monotherapy demonstrates lower rates of virological suppression when compared with lopinavir/ritonavir triple therapy and therefore should not be considered as a preferred treatment option for widespread use in antiretroviral-naive patients. SN - 1473-5571 UR - https://www.unboundmedicine.com/medline/citation/18195565/Lopinavir/ritonavir_monotherapy_or_plus_zidovudine_and_lamivudine_in_antiretroviral_naive_HIV_infected_patients_ L2 - https://doi.org/10.1097/QAD.0b013e3282f3f16d DB - PRIME DP - Unbound Medicine ER -