High virologic response rate after second-line boosted protease inhibitor-based antiretroviral therapy regimens in children from a resource limited setting

Thanyawee Puthanakit, Gonzague Jourdain, Piyarat Suntarattiwong, Kulkanya Chokephaibulkit, Umaporn Siangphoe, Tulathip Suwanlerk, Wasana Prasitsuebsai, Virat Sirisanthana, Pope Kosalaraksa, Witaya Petdachai, Rawiwan Hansudewechakul, Naris Waranawat, Jintanat Ananworanich, HIV-NAT 086 study team, Thanyawee Puthanakit, Gonzague Jourdain, Piyarat Suntarattiwong, Kulkanya Chokephaibulkit, Umaporn Siangphoe, Tulathip Suwanlerk, Wasana Prasitsuebsai, Virat Sirisanthana, Pope Kosalaraksa, Witaya Petdachai, Rawiwan Hansudewechakul, Naris Waranawat, Jintanat Ananworanich, HIV-NAT 086 study team

Abstract

Background: Limited data exist for the efficacy of second-line antiretroviral therapy among children in resource limited settings. We assessed the virologic response to protease inhibitor-based ART after failing first-line non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens.

Methods: A retrospective chart review was conducted at 8 Thai sites of children who switched to PI -based regimens due to failure of NNRTI -based regimens. Primary endpoints were HIV RNA < 400 copies/ml and CD4 change over 48 weeks.

Results: Data from 241 children with median baseline values before starting PI-based regimens of 9.1 years for age, 10% for CD4%, and 4.8 log10 copies/ml for HIV RNA were included; 104 (41%) received a single ritonavir-boosted PI (sbPI) with 2 NRTIs and 137 (59%) received double-boosted PI (dbPI) with/without NRTIs based on physician discretion. SbPI children had higher baseline CD4 (17% vs. 6%, p < 0.001), lower HIV RNA (4.5 vs. 4.9 log10 copies/ml, p < 0.001), and less frequent high grade multi-NRTI resistance (12.4% vs 60.5%, p < 0.001) than the dbPI children. At week 48, 81% had HIV RNA < 400 copies/ml (sbPI 83.1% vs. dbPI 79.8%, p = 0.61) with a median CD4 rise of 9% (+7%vs. + 10%, p < 0.005). However, only 63% had HIV RNA < 50 copies/ml, with better viral suppression seen in sbPI (76.6% vs. 51.4%, p 0.002).

Conclusion: Second-line PI therapy was effective for children failing first line NNRTI in a resource-limited setting. DbPI were used in patients with extensive drug resistance due to limited treatment options. Better access to antiretroviral drugs is needed.

Figures

Figure 1
Figure 1
Kaplan Meier estimated for time to treatment failure, defined as HIV RNA > 400 copies/ml, after switching to second line PI regimen.

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