Clinical and virological outcomes in people with advanced HIV disease initiating a locally manufactured integrase inhibitor-based regimen: A prospective cohort study

Abstract

Objective: To assess clinical, immunological, and virological responses to locally manufactured integrase-based antiretroviral therapy (ART) over nine months in treatment-naïve advanced HIV disease individuals and to identify early mortality prognostic factors.

Methods: This prospective cohort study conducted at a HIV Clinic (March 2023-August 2024) enrolled treatment-naïve individuals with advanced HIV disease. Key variables of interest included CD4 T-cell count (flow cytometry), HIV-1 RNA viral load (real-time PCR), nutritional and anthropometric indices (body mass index, mid-upper arm circumference, prognostic nutritional index) and sarcopenia (EWGSOP criteria), were assessed at baseline and at 3, 6, and 9 months. Comprehensive assessments also included clinical evaluation, standard laboratory parameters, and imaging studies.

Results: The cohort included 50 treatment-naïve individuals with advanced HIV disease. They had a mean age of 37.6 years (76% male), with a median baseline CD4 count 80 cells/mm³ and median HIV RNA of 91 800 copies/mL. Malnutrition, opportunistic infections, and sarcopenia were observed in 32% (n=16), 22% (n=11), and 14% (n=7) of patients, respectively. Altogether, mortality was 24% (12/50), with 75% of deaths occurring within first three months and a median time to death of 31 days. Among survivors, median CD4 count escalated from 93 to 236 cells/mm³, and almost all were virally suppressed by month nine. Prognostic factors of mortality involved severe malnutrition, sarcopenia, hypoalbuminaemia, CD4 count below 50 cells/mm³, viral load exceeding 100 000 copies/mL, and multi-organ abnormalities at presentation.

Conclusions: Locally produced integrase inhibitor-based ART achieved excellent responses in survivors with advanced HIV disease. Early mortality was high. Poor nutritional status, sarcopenia, severe immunosuppression, and multi-organ involvement were significantly related to mortality. This highlights the urgent need for earlier HIV diagnosis, proper nutritional screening and intervention, and management of opportunistic infections in developing countries as in Egypt.

Keywords

Advanced HIV disease / Early mortality / Integrase inhibitors / Dolutegravir / Sarcopenia / Malnutrition / Egypt

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