Monitoring the Efficacy of Antiretroviral Therapy by a Simple Reverse Transcriptase Assay in HIV-Infected Adults in Rural Vietnam

Abstract

Aim: To determine the feasibility of viral load (VL) monitoring using ExaVir™ Load in a cohort of 605 HIV treatment-naive adult patients initiating antiretroviral therapy in rural Vietnam. Materials & methods: VL monitoring every 6 months, survival and intention-to-treat analysis were used. Roche Cobas TaqMan^® VL was compared with ExaVir Load using Spearman‘s rank correlation coefficient and Bland–Altman analysis. Results: After 20.7 months mean follow-up time, 78% remained on treatment. Virologic suppression rate (VL <200 copies/ml) after 24 months was 64% in the whole cohort and 94% among patients assessed with VL. The cumulative virologic failure rate (VL >1000 copies/ml) was 6.8%. Baseline VL ≥100,000 copies/ml was predictive for virologic failure [adjusted hazard ratio: 2.26 (1.16–4.39); p = 0.016]. ExaVir Load and the Roche Cobas TaqMan showed a strong correlation (r² = 0.97; p < 0.001), high agreement (difference in log = 0.34; 95% CI: -0.35–1.03), high sensitivity (98%) and high specificity (100%). Conclusion: Using ExaVir Load to monitor efficacy of antiretroviral therapy programs in resource-limited settings is feasible.

Keywords:

• antiretroviral therapy
• ExaVir Load
• HIV
• resource-limited settings
• reverse transcriptase
• Vietnam
• virologic failure

Acknowledgements

The authors are deeply thankful to V Diwan, at IHCAR, Karolinska Institutet for providing ideas and support. The authors are also grateful to Cavidi AB, especially to C Källander and S Sjödahl for providing technical support. Finally, many thanks to V Tuong Van, N Thi Tuyet Mai, T Minh Thu, P Thi Tuoi, T Chi Thanh, P Thi Hien, D Dinh Trieu, all colleagues, health staff, external supporters and patients in the DOTARV Project for their support for this study.

Financial & competing interests disclosure

We would like to thank the Swedish International Development Cooperation Agency (SIDA), the CHAIN EU FP7, Swedish Research Council, the Division of Global Heath (IHCAR)-Karolinska Institutet, Global Fund, CDC-Lifegap Project and the Health System Research Project of Hanoi Medical University in Vietnam for providing financial and technical supports. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Additional information

Funding

We would like to thank the Swedish International Development Cooperation Agency (SIDA), the CHAIN EU FP7, Swedish Research Council, the Division of Global Heath (IHCAR)-Karolinska Institutet, Global Fund, CDC-Lifegap Project and the Health System Research Project of Hanoi Medical University in Vietnam for providing financial and technical supports. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.