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The 48-week efficacy of once-daily saquinavir/ritonavir in patients with undetectable viral load after 3 years of antiretroviral therapy.
HIV Med. 2005 Mar; 6(2):122-8.HM

Abstract

OBJECTIVES

To evaluate the efficacy and safety of once-daily saquinavir-soft-gel-capsules/ritonavir (SQV-SGC/RTV) 1600 mg/100 mg plus dual nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected patients with plasma viral load (pVL) <50 HIV-1 RNA copies/mL following 3 years of antiretroviral therapy.

METHODS

A total of 69 patients with pVL <50 copies/mL after 162 weeks of antiretroviral treatment started SQV-SGC/RTV 1600 mg/100 mg once-daily while continuing dual NRTIs. Previous treatment consisted of 66 weeks of treatment with a half/full dose of zidovudine (ZDV)/zalcitabine (ddC), followed by 2 years of SQV-SGC twice a day (bid) plus ZDV/lamivudine (3TC) or didanosine (ddI)/stavudine (d4T). Efficacy (pVL), safety and immunological changes (CD4 cell counts) were evaluated after 48 weeks in this open-label, single-arm prospective study.

RESULTS

SQV-SGC/RTV once-daily was well tolerated. No patient changed regimens or was lost to follow-up. After 48 weeks, 63 of 69 patients (91%) had pVL <50 copies/mL (five of the six remaining patients had pVL <400 copies/mL, and one patient had an unexplained rise to 39 500 copies/mL, which decreased to <50 copies/mL 12 weeks later). Median CD4 count increased from 534 cells/muL at the start of the SQV-SGC/RTV once-daily treatment to 664 cells/muL (P<0.001). Compared to the preceding 48 weeks on bid SQV-SGC, the CD4 cell count improved significantly on once-daily SQV-SGC/RTV (P<0.001).

CONCLUSIONS

These data support the use of SQV-SGC/RTV 1600 mg/100 mg once-daily with two NRTIs as a convenient, safe and cost-saving regimen to maintain viral suppression and CD4 counts for 48 weeks in this preselected cohort on highly active antiretroviral therapy (HAART) with pVL <50 copies/mL. The CD4 count rise may be a result of continued immune reconstitution in patients with well-controlled infection.

Authors+Show Affiliations

The HIV Netherlands Australia Thailand Research Collaborative (HIVNAT), The Thai Red Cross AIDS Research Center, Bangkok, Thailand. Peter.Cardiello@post.harvard.eduNo 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)

Clinical Trial
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15807718

Citation

Cardiello, P, et al. "The 48-week Efficacy of Once-daily Saquinavir/ritonavir in Patients With Undetectable Viral Load After 3 Years of Antiretroviral Therapy." HIV Medicine, vol. 6, no. 2, 2005, pp. 122-8.
Cardiello P, Srasuebkul P, Hassink E, et al. The 48-week efficacy of once-daily saquinavir/ritonavir in patients with undetectable viral load after 3 years of antiretroviral therapy. HIV Med. 2005;6(2):122-8.
Cardiello, P., Srasuebkul, P., Hassink, E., Mahanontharit, A., Samor, T., Ruxrungtham, K., Lange, J., Cooper, D., & Phanuphak, P. (2005). The 48-week efficacy of once-daily saquinavir/ritonavir in patients with undetectable viral load after 3 years of antiretroviral therapy. HIV Medicine, 6(2), 122-8.
Cardiello P, et al. The 48-week Efficacy of Once-daily Saquinavir/ritonavir in Patients With Undetectable Viral Load After 3 Years of Antiretroviral Therapy. HIV Med. 2005;6(2):122-8. PubMed PMID: 15807718.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The 48-week efficacy of once-daily saquinavir/ritonavir in patients with undetectable viral load after 3 years of antiretroviral therapy. AU - Cardiello,P, AU - Srasuebkul,P, AU - Hassink,E, AU - Mahanontharit,A, AU - Samor,T, AU - Ruxrungtham,K, AU - Lange,J, AU - Cooper,D, AU - Phanuphak,P, PY - 2005/4/6/pubmed PY - 2005/7/19/medline PY - 2005/4/6/entrez SP - 122 EP - 8 JF - HIV medicine JO - HIV Med VL - 6 IS - 2 N2 - OBJECTIVES: To evaluate the efficacy and safety of once-daily saquinavir-soft-gel-capsules/ritonavir (SQV-SGC/RTV) 1600 mg/100 mg plus dual nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected patients with plasma viral load (pVL) <50 HIV-1 RNA copies/mL following 3 years of antiretroviral therapy. METHODS: A total of 69 patients with pVL <50 copies/mL after 162 weeks of antiretroviral treatment started SQV-SGC/RTV 1600 mg/100 mg once-daily while continuing dual NRTIs. Previous treatment consisted of 66 weeks of treatment with a half/full dose of zidovudine (ZDV)/zalcitabine (ddC), followed by 2 years of SQV-SGC twice a day (bid) plus ZDV/lamivudine (3TC) or didanosine (ddI)/stavudine (d4T). Efficacy (pVL), safety and immunological changes (CD4 cell counts) were evaluated after 48 weeks in this open-label, single-arm prospective study. RESULTS: SQV-SGC/RTV once-daily was well tolerated. No patient changed regimens or was lost to follow-up. After 48 weeks, 63 of 69 patients (91%) had pVL <50 copies/mL (five of the six remaining patients had pVL <400 copies/mL, and one patient had an unexplained rise to 39 500 copies/mL, which decreased to <50 copies/mL 12 weeks later). Median CD4 count increased from 534 cells/muL at the start of the SQV-SGC/RTV once-daily treatment to 664 cells/muL (P<0.001). Compared to the preceding 48 weeks on bid SQV-SGC, the CD4 cell count improved significantly on once-daily SQV-SGC/RTV (P<0.001). CONCLUSIONS: These data support the use of SQV-SGC/RTV 1600 mg/100 mg once-daily with two NRTIs as a convenient, safe and cost-saving regimen to maintain viral suppression and CD4 counts for 48 weeks in this preselected cohort on highly active antiretroviral therapy (HAART) with pVL <50 copies/mL. The CD4 count rise may be a result of continued immune reconstitution in patients with well-controlled infection. SN - 1464-2662 UR - https://www.unboundmedicine.com/medline/citation/15807718/The_48_week_efficacy_of_once_daily_saquinavir/ritonavir_in_patients_with_undetectable_viral_load_after_3_years_of_antiretroviral_therapy_ L2 - https://doi.org/10.1111/j.1468-1293.2005.00274.x DB - PRIME DP - Unbound Medicine ER -