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IMPACT OF RALTEGRAVIR OR EFAVIRENZ ON CELL-ASSOCIATED HUMAN IMMUNODEFICIENCY VIRUS-1 (HIV-1) DEOXYRIBONUCLEIC ACID AND SYSTEMIC INFLAMMATION IN HIV-1/TUBERCULOSIS COINFECTED ADULTS INITIATING ANTIRETROVIRAL THERAPY
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Laboratoire de Virologie. Hôpital Saint Louis. Assistance Publique-Hôpitaux de Paris. Paris, France / INSERM. Université de Paris. Paris, France.
ISPED. Inserm. Bordeaux Population Health Research Center. Team MORPH3EUS. Bordeaux University. Bordeaux, France.
Maladies Infectieuses et Tropicales. Hôpital Saint Louis. Assistance Publique-Hôpitaux de Paris. Paris, France.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Laboratoire de Biochimie. Hôpital Saint Louis. Assistance Publique-Hôpitaux de Paris. Paris, France.
Laboratoire de Pharmacologie. Hôpital Saint-Louis Assistance Publique-Hôpitaux de Paris. Paris, France.
Laboratoire de Pharmacologie. Hôpital Saint-Louis Assistance Publique-Hôpitaux de Paris. Paris, France.
Laboratoire d'Hématologie. Hôpital Saint-Louis Assistance Publique-Hôpitaux de Paris. Paris, France.
Hospital Geral de Nova Iguaçu. Departamento de DST/AIDS. Rio de Janeiro, RJ, Brasil.
Hospital Universitário Professor Edgar Santos. Laboratório de Pesquisa em Doenças Infecciosas. Salvador, BA, Brasil.
Parthenon Sanatorium Hospital. Health State Secretariat. Porto Alegre, RS, Brazil.
INSERM. Université de Paris. Paris, France.
ISPED. Inserm. Bordeaux Population Health Research Center. Team MORPH3EUS. Bordeaux University. Bordeaux, France / Pole de Santé Publique. Service d'Information Medicale. Bordeaux, France.
INSERM. Université de Paris. Paris, France / Maladies Infectieuses et Tropicales. Hôpital Saint Louis. Assistance Publique-Hôpitaux de Paris. Paris, France.
Laboratoire de Virologie. Hôpital Saint Louis. Assistance Publique-Hôpitaux de Paris. Paris, France / INSERM. Université de Paris. Paris, France.
ISPED. Inserm. Bordeaux Population Health Research Center. Team MORPH3EUS. Bordeaux University. Bordeaux, France.
Maladies Infectieuses et Tropicales. Hôpital Saint Louis. Assistance Publique-Hôpitaux de Paris. Paris, France.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Laboratoire de Biochimie. Hôpital Saint Louis. Assistance Publique-Hôpitaux de Paris. Paris, France.
Laboratoire de Pharmacologie. Hôpital Saint-Louis Assistance Publique-Hôpitaux de Paris. Paris, France.
Laboratoire de Pharmacologie. Hôpital Saint-Louis Assistance Publique-Hôpitaux de Paris. Paris, France.
Laboratoire d'Hématologie. Hôpital Saint-Louis Assistance Publique-Hôpitaux de Paris. Paris, France.
Hospital Geral de Nova Iguaçu. Departamento de DST/AIDS. Rio de Janeiro, RJ, Brasil.
Hospital Universitário Professor Edgar Santos. Laboratório de Pesquisa em Doenças Infecciosas. Salvador, BA, Brasil.
Parthenon Sanatorium Hospital. Health State Secretariat. Porto Alegre, RS, Brazil.
INSERM. Université de Paris. Paris, France.
ISPED. Inserm. Bordeaux Population Health Research Center. Team MORPH3EUS. Bordeaux University. Bordeaux, France / Pole de Santé Publique. Service d'Information Medicale. Bordeaux, France.
INSERM. Université de Paris. Paris, France / Maladies Infectieuses et Tropicales. Hôpital Saint Louis. Assistance Publique-Hôpitaux de Paris. Paris, France.
Laboratoire de Virologie. Hôpital Saint Louis. Assistance Publique-Hôpitaux de Paris. Paris, France / INSERM. Université de Paris. Paris, France.
Abstract
Background: In view of the fast viremia decline obtained with integrase inhibitors, we studied the respective effects of initiating
efavirenz (EFV) or raltegravir (RAL)-based antiretroviral therapy (ART) regimens on human immunodeficiency virus (HIV)-1 deoxyribonucleic acid (DNA) levels and inflammation biomarkers in the highly inflammatory setting of advanced HIV-1 disease with
tuberculosis (TB) coinfection. Methods: We followed cell-associated HIV-1 DNA, high-sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), soluble CD14 and D-Dimer levels for 48 weeks after ART initiation in the participants to the ANRS12-180 REFLATE-TB study. This phase II open-label randomized study included ART-naive people with HIV and TB treated with rifampicin to receive RAL 400 mg twice daily (RAL400), RAL 800 mg twice daily (RAL800) or EFV 600 mg QD with tenofovir and lamivudine. Results: In 146 participants, the median (interquartile range [IQR]) week (W)0 HIV-1 DNA level was 4.7 (IQR, 4.3–5.1) log10 copies/106 CD4+ , and the reduction by W48 was −0.8 log10 copies/106 CD4+ on EFV, −0.9 on RAL400, and −1.0 on RAL800 (P = .74). Baseline median (IQR) hsCRP, IL-6, sCD14, and D-Dimer levels were 6.9 (IQR, 3.3–15.6) mg/L, 7.3 (IQR, 3.5–12.3) pg/mL, 3221 (IQR, 2383–4130) ng/mL, and 975 (IQR, 535–1970) ng/mL. All biomarker levels decreased over the study: the overall W0–W48 mean (95% confidence interval) fold-change on ART was 0.37 (IQR, 0.28–0.48) for hsCRP, 0.42 (IQR, 0.35–0.51) for IL-6, 0.51 (IQR, 0.47–0.56) for sCD14, and 0.39 (IQR, 0.32–0.47) for D-Dimers. There were no differences in biomarker reduction across treatment arms. Conclusions: In participants with HIV and TB, EFV, RAL400, or RAL800 effectively and equally reduced inflammation and HIV-1 DNA levels.
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