Efficacy and Safety of Tenofovir and Lamivudine in Combination with Efavirenz in Patients Co-infected with Human Immunodeficiency Virus and Hepatitis B Virus in China

Ya-Song Wu, Wei-Wei Zhang, Xue-Mei Ling, Lian Yang, Shao-Biao Huang, Xi-Cheng Wang, Hao Wu, Wei-Ping Cai, Min Wang, Hui Wang, Yan-Fen Liu, Hao-Lan He, Fei-Li Wei, Zun-You Wu, Fu-Jie Zhang, Ya-Song Wu, Wei-Wei Zhang, Xue-Mei Ling, Lian Yang, Shao-Biao Huang, Xi-Cheng Wang, Hao Wu, Wei-Ping Cai, Min Wang, Hui Wang, Yan-Fen Liu, Hao-Lan He, Fei-Li Wei, Zun-You Wu, Fu-Jie Zhang

Abstract

Background: The prevalence of hepatitis B virus (HBV) infection is high among individuals infected with human immunodeficiency virus (HIV) in China. Both HIV and HBV can be treated with tenofovir disoproxil fumarate (TDF) and lamivudine (3TC), so we evaluated the safety and efficacy of combination antiretroviral therapy (ART) that included TDF, 3TC, and efavirenz (EFV) among ART-naive individuals who were co-infected with HIV and HBV.

Methods: One hundred HIV/HBV co-infected ARV-naive individuals were started on the regimen of TDF, 3TC, and EFV, and the levels of plasma HBV DNA, HIV RNA, and biochemical evaluation related to the function of liver and kidney were analyzed.

Results: Concerning efficacy, this study found that by week 48, the vast majority co-infected participants receiving this ART regimen had undetectable HBV DNA levels (71%) and/or HIV RNA levels (90%). Concerning safety, this study found that the median estimated glomerular filtration rate of participants decreased from baseline (109 ml·min-1·1.73 m-2) to week 12 (104 ml·min-1·1.73 m-2) but was almost back to baseline at week 48 (111 ml·min-1·1.73 m-2).

Conclusion: This combination ART regimen is safe and effective for patients with HIV/HBV co-infection.

Trial registration: ClinicalTrials.gov, NCT01751555; https://ichgcp.net/clinical-trials-registry/NCT01751555.

Figures

Figure 1
Figure 1
Changes in hepatitis B virus DNA log10 copies/ml levels from baseline over 48 weeks of combination antiretroviral therapy (Z = –8.28, P < 0.001 compared to baseline). Error bars indicate interquartile range.
Figure 2
Figure 2
CD4+ T-cell counts over 48 weeks of combination antiretroviral therapy. Error bars indicate interquartile range.
Figure 3
Figure 3
Liver and kidney measures over 48 weeks of combination antiretroviral therapy. (a) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels over 48 weeks of combination antiretroviral therapy. Error bars indicate interquartile range. (b) Estimated glomerular filtration rate (eGFR) over 48 weeks of combination antiretroviral therapy. Error bars indicate interquartile range.

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