Human Immunodeficiency Virus (HIV) is a retrovirus belonging to Retroviridae family, Orthoretrovirinae subfamily and Lentivirusgenus. Two types are distinguished on the antigenicity basis: HIV-1 and HIV-2 [1][2]. HIV-1 is widespread on all continents and is responsible for the global pandemic, while HIV-2 is found mainly in West Africa [3]. HIV-1, because of its transmissibility and pathogenicity, is more important in inducing severe immune deficiency than HIV-1 [4][5]. HIV infection primarily targets immune system cells, weakening them against infections and certain types of cancer. In this way, reduced immune cell function leads to a progressive immune deficiency in infected patients, whose immune function is then measured by CD4 cell count [3]. Acquired immunodeficiency syndrome (AIDS) is defined as a group of infectious and/or tumoral manifestations caused by the human immunodeficiency virus (HIV). To date, there are three (03) main transmission modes: sexual transmission; transmission by exposure to blood; vertical transmission (mother-to-child transmission) [6]-[8].

HIV remains a global public health problem, resulting in 40.4 million deaths to date. At the end of December 2022, the number of people living with HIV was estimated at 39 million, and 29.8 million people had access to antiretroviral therapy. In 2022, 630,000 people died of HIV-related causes and 1.3 million were infected with HIV [9].

According to estimates, 7.7 million deaths will be added to the heavy toll of HIV infection if nothing is done in the next ten (10) years. This is why the Joint United Nations Programme on HIV/AIDS (UNAIDS) has set the new global targets 95 - 95 - 95 (increase the percentage of persons who know their HIV status, receive antiretroviral therapy, and have achieved viral suppression) to avoid the worst-case scenario [9]. At the same time, in West and Central Africa, there were 4 5.1 million [4.5 million - 5.9 million] people living with HIV, of whom 79% [61% - 96%] had access to antiretroviral treatment, and around 190,000 [130,000 - 280,000] new HIV infections [9].

In Mali, HIV prevalence stands at 1.1%, with 110,000 people living with HIV, according to the demographic and health survey conducted by the Mali CelluleSectoriellede Lutte Contre le SIDA(Coordinating Committee for HIV/AIDS) [10][11]. The city of Bamako remains the most affected, with 1.7%. The same survey reports that women are more infected than men, with a prevalence of 1.3% versus 0.8% [10].

However, to prevent this infection progressing to AIDS, the use of ART is an indispensable tool. To achieve this, ART must render the plasma viral load undetectable. Since ART is a lifelong process, its effectiveness depends on good compliance, which is the key factor in the success or failure of treatment. Poor compliance can lead to treatment failure, worsening of the disease and recurrence of opportunistic infections. The most serious consequence of non-adherence is the emergence of ART-resistant strains, making treatment more difficult and potentially fatal for the patient [12]. Biological monitoring plays an essential role in the management of HIV infection. In untreated patients, it helps determine the right time to start antiretroviral treatment, or to begin prevention of certain infectious diseases. The follow-up of treated patients enables the efficacy and tolerance of treatment to be verified.

The complexity of HIV management with continuous multitherapy motivated us to undertake this study to determine the outcome of ART in People Living With HIV/AIDS (PLHIV) under care.

The aim was to study the monitoring of viral load and CD4 T lymphocyte count in PLHIV under ART at the medical biology laboratory in Point G Hospital in Mali.

The large-scale establishment of care centers for people living with HIV/AIDS through antiretroviral therapy has contributed to one of the greatest successes of Mali’s HIV response program in recent years. It has been consistently reported that ART suppresses HIV RNA to levels below the detection threshold and reduces clinical progression risk [16][17]. Despite these advances, treatment failures due to HIV drug resistance, compounded by poor adherence, pose a major challenge for the ART program. That is why the WHO recommends regular monitoring of viral load and CD4 T-cell counts as part of antiretroviral therapy.

In this study, we conducted a longitudinal study to assess viral load and CD4 T-cell counts in people living with HIV who are on antiretroviral therapy.

This study found that 69.5% of the patients were female, with a male-to-female sex ratio of 0.4. These results are consistent with those reported by Zenash et al. in Ethiopia [18] and Zoungrana et al. in Burkina Faso [19], who also observed an overrepresentation of women in their cohorts 69.9% and 65.1%, respectively with sex ratios of 0.4 and 0.5. These results could be explained by the particular vulnerability of women especially to sexually transmitted infections such as HIV/AIDS in the African region, which, according to the WHO, is the hardest-hit region. Furthermore, women seek medical care more often than men, whether for gynecological issues or reproductive health concerns, which makes them more likely to undergo HIV testing. However, other studies, such as the one by Jacomet et al. [20], conducted in France, show a prédominance of males (68%), which may be explained by cultural differences between the two populations studied.

The [39 - 48] age group was the most represented, accounting for 32.9% of the sample. The mean age was 40.55 ± 10.7 years, with ages ranging from 19 to 67 years. Mean ages vary across studies but tend to fall within a similar range, reflecting the working-age population most affected by the epidemic. Mouhari Touré et al. found similar results in their study in Togo, with a median age of 35 but a female prevalence of 68.6% [21]. Another study conducted in Togo by Potchoo et al., which aimed to assess adherence to antiretroviral therapy among PLHIV, showed a median age similar to ours (36.8%) and the same age group most affected by the infection, but with a higher percentage: 83.7% compared to 32.9% in our study [22]. The majority of patients lived in Bamako (81.7%). The predominance of urban residents in our study likely reflects better access to care in urban areas compared to rural areas, where medical infrastructure may be inadequate. These results are similar to those reported by Sissoko in Mali in 2024 [23], where nearly all of these patients lived in Bamako (97.03%).

Although HIV infection is often diagnosed at advanced clinical stages 3 and 4, according to some authors, as reported by Lewden et al. [24] and Willy S. David et al. [25], the majority of patients included in the study were in clinical stage 1 of the WHO classification (60.9%). The diagnosis and management of HIV infection are reportedly occurring at an increasingly early stage, thanks to the nationwide adoption of the WHO’s “test and treat” recommendations, which are included in the document outlining national standards and protocols for the management of HIV infection. The implementation of this protocol in Mali could also explain why the majority of our patients received therapy based on the tenofovir-lamivudine-dolutegravir combination in 62.2% of cases, followed by the Tenofovir-Lamivudine-Efavirenz combination (32.9%). These results are consistent with those reported by Sall et al. in 2023 in Mali, where a combination of Tenofovir-Lamivudine-Dolutegravir is used in 80.3% of cases, which constitutes the first-line treatment in Mali [26]. Nearly all of the subjects in the studies were HIV-1-positive (98.8%); HIV-1+2 was present in 1.2% of cases. This distribution is consistent with the findings reported by Sall in 2023 [26]. This finding is consistent with data from the literature, which indicate that HIV-1 is more prevalent worldwide than HIV-2, particularly in sub-Saharan Africa [27].

The results of this study show that at enrollment, 56.1% of patients had a viral load > 1,000 copies/mL, compared with 24.4% after 6 months of treatment. Indeed, 63.4% of patients had a viral load <40 copies/mL at M6, and nearly all (86.6%) patients had a viral load <40 copies/mL which means, undetectable at M12 of treatment. This gradual decrease in viral load leading to virologic suppression demonstrates the effectiveness of the treatment protocols implemented in Mali since 2019 in accordance with WHO recommandations [12]. A significant correlation was observed between treatment duration and viral load at M12 (p = 0.03). Virologic suppression was greater with longer treatment duration. This is consistent with the study by Calmy et al. [28], which reported virologic suppression in 88% of patients on the TDF-3TC-DTG regimen after 93 months of treatment. A study conducted in Mali initially included patients with a viral load > 1,000 copies/mL, who accounted for 64.36% of cases. At M6 and M12, this rate had decreased by 8.91% and 5.94%, respectively [23]. However, a Kenyan study reported a viral suppression rate (72%) even with lower adherence. However, a Kenyan study reported a viral suppression rate (72%) even with lower adherence [29]. The differences could be attributed to the quality of follow-up, adherence strategies, and the prevalence of pre-existing ART resistance. The predominant use of the TDF-3TC-DTG regimen (62.2% in our study) is a strength, as this treatment is associated with high rates of virologic suppression, as has also been reported [30].

With regard to CD4 counts, only 7.3% of patients had a count > 500/mm³ after M12 of treatment. This result is lower than that reported by Sarıgül Yıldırım et al., [31], who found a significant increase in CD4 counts to > 500/mm³ in 90% of patients after one year. As reported by E. Lozès et al. [32] in their study, approximately 9 out of 10 HIV-positive patients were immunocompromised at the start of ART; 87.7% of these, including (20.3%), were severely immunocompromised. These differences may be due to the high proportion of tests not performed in our study (at M6 and M12), which could limit the interpretation of the results. Local factors such as the quality of follow-up due to patients missing appointments or the lack of centralized data on patients living with HIV who are followed at Point G University Hospital.

Overall, our study found a low level of achievement of CD4 counts. At the conclusion of our study, 86.6% of our patients responded favorably to ART. Nevertheless, efforts to improve comprehensive care could enhance these results. Good treatment adherence remains a key factor in the success of ART and, consequently, prevents treatment failure and the emergence of strains that are multidrug-resistant to antiretrovirals.

AIDS:Acquired Immunodeficiency Syndrome, ART: Antiretroviral therapy, ARV: Antiretroviral, CD:Cluster of Differentiation, DTG: Dolutégravir, EDTA:Ethylenediaminetetraacetic acid, HIV: Human Immunodeficiency Virus, PLHIV: People living with HIV, RNA: Ribonucleic acid, 3TC: Lamivudine, TDF:Ténofovir Disoproxil Fumarate, WHO:World Health Organization.

All authors read and approved the final manuscript. Study concept and design: MTD, AM, BS, DK, Clinical and pathological data: YC, Data analysis and interpretation: MTD, BS, DK, Writing of the manuscript: MTD, AM, BS, DK Critical review of the manuscript for significant intellectual content: YK, DMC, MAB, MM, AIM, OAD, FC.

We obtained prior approval from the department head, the ethics committee, and the Medical Institution Committee (CME) of Point-G University Hospital, Bamako. This study was conducted while ensuring the complete anonymity of the participants. Under no circumstances may the study data be used to formally identify a study participant.

The authors thank all clinicians and participants in the study, Center of Research and Training on Molecular Pathology (CREFPAM), Faculty of Medicine and Odontostomatology/Uniniversity of Sciences, Techniques and Technologies of Bamako, and Point-G University Hospital, Bamako for logistical support.