Abstract

BackgroundHIV/AIDS patients who fail to respond to first-line treatment protocols are switched to second-line ART. Identifying factors that influence effective second-line treatment can improve utilization of limited medical resources. We investigated the efficacy of long-term second-line anti-retroviral therapy (ART) after first-line virologic failure as well as the impact of non-nucleotide reverse transcriptase inhibitor (NNRTI), nucleotide reverse transcriptase inhibitor (NRTI), and protease inhibitor (PI) resistance mutations and medication adherence on ineffective viral suppression.MethodsA total of 120 patients were evaluated at 6, 12, 18, 24, and 48 months after initiation of second-line ART; a paper questionnaire was administered via a face-to-face interview and venous blood samples were collected. CD4+ T cell count, viral load, and drug resistance genotypes were quantified.ResultsCD4+ T cell counts increased from 170 cells/μL (IQR 100–272) at baseline to 359 cells/μL (IQR 236–501) after 48 months of second-line treatment. Viral load (log10) decreased from 4.58 copies/mL (IQR 3.96–5.17) to 1.00 copies/mL (IQR 1.00–3.15). After switching to second-line ART, nine patients newly acquired the NRTI drug-resistant mutation, M184 V/I. No major PI resistance mutations were detected. Logistical regression analysis indicated that medication adherence < 90% in the previous month was associated with ineffective viral suppression; baseline high/low/moderate level resistance to 3TC/TDF was protective towards effective viral suppression.ConclusionsLong-term second line ART was effective in the Henan region of China. Drug resistance mutations to NRTIs were detected in patients receiving second-line ART, suggesting that drug resistance surveillance should be continued to prevent the spread of resistant strains. Patient medication adherence supervision and management should be strengthened to improve the efficacy of antiviral treatment.

Highlights

  • Human immunodeficiency virus (HIV)/Acquired immunodeficiency syndrome (AIDS) patients who fail to respond to first-line treatment protocols are switched to secondline anti-retroviral therapy (ART)

  • In 2009, patients with failure of the first-line treatment protocol have switched to second-line ART, which is comprised of 3TC, TDF (Tenofovir), and Lopinavir/ ritonavir (Lpv/r) (Lopinavir/ritonavir)

  • Study population Patients were recruited from Henan between August 2009 and February 2010. Inclusion criteria were those listed in the Chinese National Free AIDS Antiretroviral Therapy Manual issued in 2009 [24] and in the WHO guidelines for antiretroviral therapy for HIV infection in adults and adolescents [25]: (1) ≥18 years of age; (2) virologic failure of first-line therapy, defined as a plasma HIV-1 RNA level > 400 copies/mL after 6 months of treatment or an HIV-1 RNA level > 1000 copies/mL after initial virologic suppression; (3) virologic treatment failure confirmed: viral load > 1000 copies/mL after patients resumed first-line treatment for one month with rectified treatment compliance; (4) second-line therapy protocol including lamivudine (3TC), tenofovir (TDF), and lopinavir/ritonavir (LPV/r) as the second-line antiretroviral regimen; and (5) at least one follow-up visit after the switch to the second-line antiretroviral therapy regimen

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Summary

Introduction

HIV/AIDS patients who fail to respond to first-line treatment protocols are switched to secondline ART. This policy is comprised of 1) free antiretroviral therapy to rural patients and low-income urban patients, 2) free HIV screening and counseling, 3) free ART for pregnant women with HIV to prevent mother-to-child transmission along with free HIV testing for newborns, 4) free education for children orphaned by AIDS, and free care and economic assistance to households with members suffering from HIV/AIDS [2] In accordance with these guidelines, the first line therapy regimen for HIV patients includes two nucleotide analogue reverse transcriptase inhibitors (NRTIs) and one non-nucleotide analogue reverse transcriptase inhibitors (NNRTIs) [3]. More than 55,000 patients have received second line ART in China as of 2016 [8]

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