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Efficacy and safety of ritonavir-boosted dual protease inhibitor therapy in antiretroviral-naive HIV-1-infected patients: the 2IP ANRS 127 study.
J Antimicrob Chemother. 2009 Jul; 64(1):118-25.JA

Abstract

OBJECTIVES

We evaluate the efficacy and tolerability of ritonavir-boosted dual protease inhibitor as a nucleoside reverse transcriptase inhibitor-sparing regimen in a prospective open-label randomized pilot trial in antiretroviral-naive patients.

METHODS

Thirty patients received fosamprenavir/atazanavir/ritonavir (Group 1) and 31 patients received saquinavir/atazanavir/ritonavir (Group 2). The primary endpoint for efficacy was the rate of early virological success, defined as plasma viral load <50 copies/mL at week 16. The study is registered with ClinicalTrials.gov (NCT00122603).

RESULTS

At baseline, median (range) viral load was 4.8 log(10) copies/mL (4.0-5.7) and the median CD4 cell count was 271/mm(3) (197-740). Viral load was <50 copies/mL in 12/30 patients [40%, 95% confidence interval (CI) 23%-58%] and 13/31 patients (42%, 95% CI 25%-59%) at week 16 in Groups 1 and 2, respectively. Patients with failing regimens (viral load >or=400 copies/mL at week 16 or >or=50 copies/mL at week 24) were switched to a standard antiretroviral regimen. At week 48, by an intention-to-treat analysis, 23/30 patients (77%) and 26/31 patients (84%) had plasma HIV-1 RNA <50 copies/mL in Groups 1 and 2, respectively. Four patients discontinued treatment for adverse events, all before week 4. No major changes in the protease gene were detected at treatment failure relative to baseline. Baseline viral load <50 000 copies/mL was the only predictor of virological success at week 16.

CONCLUSIONS

Ritonavir-boosted dual protease inhibitor regimens targeting only one step of viral replication were insufficient to rapidly suppress plasma HIV RNA to <50 copies/mL in antiretroviral-naive patients with high viral load at baseline.

Authors+Show Affiliations

Service des Maladies Infectieuses et Tropicales, AP-HP, Groupe Hospitalier Bichat-Claude Bernard, Paris, France. roland.landman@paris7.jussieu.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)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19420019

Citation

Landman, Roland, et al. "Efficacy and Safety of Ritonavir-boosted Dual Protease Inhibitor Therapy in Antiretroviral-naive HIV-1-infected Patients: the 2IP ANRS 127 Study." The Journal of Antimicrobial Chemotherapy, vol. 64, no. 1, 2009, pp. 118-25.
Landman R, Capitant C, Descamps D, et al. Efficacy and safety of ritonavir-boosted dual protease inhibitor therapy in antiretroviral-naive HIV-1-infected patients: the 2IP ANRS 127 study. J Antimicrob Chemother. 2009;64(1):118-25.
Landman, R., Capitant, C., Descamps, D., Chazallon, C., Peytavin, G., Katlama, C., Pialoux, G., Bentata, M., Brun-Vézinet, F., Aboulker, J. P., & Yéni, P. (2009). Efficacy and safety of ritonavir-boosted dual protease inhibitor therapy in antiretroviral-naive HIV-1-infected patients: the 2IP ANRS 127 study. The Journal of Antimicrobial Chemotherapy, 64(1), 118-25. https://doi.org/10.1093/jac/dkp146
Landman R, et al. Efficacy and Safety of Ritonavir-boosted Dual Protease Inhibitor Therapy in Antiretroviral-naive HIV-1-infected Patients: the 2IP ANRS 127 Study. J Antimicrob Chemother. 2009;64(1):118-25. PubMed PMID: 19420019.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of ritonavir-boosted dual protease inhibitor therapy in antiretroviral-naive HIV-1-infected patients: the 2IP ANRS 127 study. AU - Landman,Roland, AU - Capitant,Catherine, AU - Descamps,Diane, AU - Chazallon,Corine, AU - Peytavin,Gilles, AU - Katlama,Christine, AU - Pialoux,Gilles, AU - Bentata,Michelle, AU - Brun-Vézinet,Francoise, AU - Aboulker,Jean-Pierre, AU - Yéni,Patrick, AU - ,, Y1 - 2009/05/06/ PY - 2009/5/8/entrez PY - 2009/5/8/pubmed PY - 2009/7/28/medline SP - 118 EP - 25 JF - The Journal of antimicrobial chemotherapy JO - J Antimicrob Chemother VL - 64 IS - 1 N2 - OBJECTIVES: We evaluate the efficacy and tolerability of ritonavir-boosted dual protease inhibitor as a nucleoside reverse transcriptase inhibitor-sparing regimen in a prospective open-label randomized pilot trial in antiretroviral-naive patients. METHODS: Thirty patients received fosamprenavir/atazanavir/ritonavir (Group 1) and 31 patients received saquinavir/atazanavir/ritonavir (Group 2). The primary endpoint for efficacy was the rate of early virological success, defined as plasma viral load <50 copies/mL at week 16. The study is registered with ClinicalTrials.gov (NCT00122603). RESULTS: At baseline, median (range) viral load was 4.8 log(10) copies/mL (4.0-5.7) and the median CD4 cell count was 271/mm(3) (197-740). Viral load was <50 copies/mL in 12/30 patients [40%, 95% confidence interval (CI) 23%-58%] and 13/31 patients (42%, 95% CI 25%-59%) at week 16 in Groups 1 and 2, respectively. Patients with failing regimens (viral load >or=400 copies/mL at week 16 or >or=50 copies/mL at week 24) were switched to a standard antiretroviral regimen. At week 48, by an intention-to-treat analysis, 23/30 patients (77%) and 26/31 patients (84%) had plasma HIV-1 RNA <50 copies/mL in Groups 1 and 2, respectively. Four patients discontinued treatment for adverse events, all before week 4. No major changes in the protease gene were detected at treatment failure relative to baseline. Baseline viral load <50 000 copies/mL was the only predictor of virological success at week 16. CONCLUSIONS: Ritonavir-boosted dual protease inhibitor regimens targeting only one step of viral replication were insufficient to rapidly suppress plasma HIV RNA to <50 copies/mL in antiretroviral-naive patients with high viral load at baseline. SN - 1460-2091 UR - https://www.unboundmedicine.com/medline/citation/19420019/Efficacy_and_safety_of_ritonavir_boosted_dual_protease_inhibitor_therapy_in_antiretroviral_naive_HIV_1_infected_patients:_the_2IP_ANRS_127_study_ L2 - https://academic.oup.com/jac/article-lookup/doi/10.1093/jac/dkp146 DB - PRIME DP - Unbound Medicine ER -