Clinical Outcomes and Role of Non-adherence in Immediate Antiretroviral Therapy Among Persons Living With Hiv - Attending Kemri Ccc, Nairobi Kenya

Abstract

Introduction: The greatest burden of HIV is experienced in low and middle-income countries (LMIC), particularly in sub-Saharan Africa, which is home to more than two-thirds of all people living with HIV worldwide. The World Health Organization's (WHO) "Test and Treat all" guidance of September 2015 aimed to prevent illness and death among people living with HIV and avert new infections by reducing onward HIV transmission. This has been recognized as the primary strategy for achieving the Joint United Nations Programme on HIV/AIDS (UNAIDS) 90‐90‐90 targets. By 2019, Kenya Test and Treat had been adopted in >95% of the ART treatment sites. Further, in 2019 Kenya adopted the WHO new first-line ART recommendations comprising Tenofovir/Lamivudine/Dolutegravir - TDF + 3TC + DTG. Despite these efforts, new HIV infections and AIDS‐related mortality remain higher in developing countries, including Kenya. The clinical outcome of this model and the new ART regimen has not been evaluated in Kenya. Objectives: This longitudinal study evaluated the immunological, virologic, hematological, and blood chemistry changes three and six months into ART treatment on the TDF+3TC+DTG regimen. It also evaluated the role of patients' ART adherence on clinical outcomes. Materials and Methods: This longitudinal enrolled 141 patients living with HIV initiating TDF + 3TC + DTG at Family AIDS Care and Education Services (FACES) program, based at the Center for Respiratory Disease Research (CRDR) Kenya Medical Research Institute (KEMRI), Nairobi and followed them up for six months. At baseline, month 3 and 6-time points, 5ml blood samples were collected, and structured interviews using an HIV treatment adherence tool was used to gather patient social and demographic information. The CD4, HIV viral load, complete blood count, ALT, AST and creatinine was determined following manufacturers’ instructions. Descriptive statistics were used to analyze patient characteristics and laboratory parameters, with continuous variables assessed for outliers and illogical values flagged and corrected by checking patient records. STATA v 13 was used for statistical analysis, on-parametric Wilcoxon t-test was used to assess variations in CD4 cells, viral load, hematological parameters, and hepatic enzymes at 3- and 6-months post-ART initiation. Correlation analysis was also performed to determine the relationship between non-adherence and hematological parameters, hepatic enzymes, CD4, and viral load. The findings were presented in tables, line graphs, histograms, and box plots. Results: This study cohort enrolled 141 subjects where 9 subjects were lost to follow up leaving 132 subjects,74 females and 58 males. Of the enrolled participants (21.3%) experienced common ART side effects upon initiation of ART, and at baseline, 41% had immunological failure with CD4 cells <250 cells/mm3. After 6 months of ART use, the mean viral load decreased to 178.8542, with a standard deviation of 385.8, and 97.8% of participants achieved viral load suppression, with only 2% experiencing virologic failure. An increase in CD4 count was observed with an accelerated increase in the mean CD4 count after the first 3 months on ART and the mean value rising to 490 at the 6th month mark. The mean hemoglobin level increased from 7.8 at baseline to 14.8 g/dL at 6 months with 65.3% of the subjects having Hb levels greater than 13 g/dL at 6 months follow up. The highest increment of lymphocyte and platelet was observed, at 6 months with a mean value of 111.2 and 290.4 for lymphocytes and platelets respectively. However, all subjects in the study presented elevated creatinine levels, which may be indicative of potential renal function abnormalities. Overall, these findings provide important insights into the immunological and virological outcomes of ART in Kenya and suggest that it is an effective approach for managing HIV in this population. Significance of the Study: The immune-virologic benefits of immediate ART initiation among patients living with HIV have not been studied in detail in Kenya five years since being adopted. This study provides evidence of the effectiveness of the immediate ART initiation in patients diagnosed with HIV, this strategy and the current first-line ART regimen used in Kenya to promote the uptake of services and maximize their impact on individual and population health outcomes. These findings can inform clinical decision-making and contribute to strengthening policies and programs to improve the health outcomes of patients living with HIV in Kenya and other similar settings. By extrapolating from these results, considerations can be made on how similar strategies and lessons might be applied to enhance HIV care in a global context, potentially broadening the study's impact and contributing to the broader field of HIV management. This study may also serve as a model for improving HIV care in regions in other low- and middle-income countries where similar challenges and circumstances exist