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    • br Conflicts of interest br Introduction Antiretroviral

    2021-12-16


    Conflicts of interest
    Introduction Antiretroviral therapy (ART) is effective in reducing mortality (Detels et al., 1998), and preventing mother-to-child transmission (MTCT) (CDC, 1994, Connor et al., 1994) and sexual transmission of HIV (Cohen et al., 2011). However, the optimal time to start treatment has been a topic of debate (WHO, 2016), as a result, HIV treatment guidelines have been regularly revised to balance risks and benefits of treatment. Initiation of ART immediately after diagnosis is currently recommended (WHO, 2016, Günthard et al., 2016, Ryom et al., 2016) following reports of clinical trials demonstrating the benefit of starting ART as early as possible (Kitahata et al., 2009, Group TAS, 2015, Group ISS, 2015, O’Connor et al., 2016). The effectiveness of ART in actual clinical settings might be inferior to what is reported by clinical trials, because clinical trial participants are more likely to be adherent to treatment than those treated in actual program settings. The benefit of early ART might even be very minimal among young asymptomatic adults with high level of CD4 count, as they have poor treatment adherence and retention (Nachega et al., 2014, Grimsrud et al., 2015, Hu et al., 2017), which could increase drug resistance (Meresse et al., 2014), and impact the potential benefit of early ART (Hu et al., 2017). In fact, a sub-group analysis of a clinical trial among adults aged below 30 years with CD4 count above 500cells/mm3 showed that those initiated treatment and those deferred treatment have similar rate of disease progression in the first 18 months (Schechter, 2018). This finding demonstrates that the benefit of early ART is not uniform across different patient groups. Therefore, observational studies are essential to clarify concerns of early Melanocyte stimulating hormone release inhibiting factor of ART. There are also reports indicating a greater risk of adverse outcomes (Nansseu and Bigna, 2017, Jose et al., 2014) associated with early ART initiation. Although newest antiretroviral drugs are more tolerable and have fewer side effects, they are not commonly used in low income settings. The burden of HIV/AIDS in Ethiopia is substantial. It is estimated that 665,116 (1.1%) adults were living with the virus in 2016 and the majority (61.5%) were women (UNAIDS, 2016). At the time of the study, indication to start ART for adults in Ethiopia was based on CD4 count or disease progression. However, pregnant women were started on ART up on diagnosis to prevent mother-to-child transmission (Federal HIV Prevention and Control Office of Ethiopia, 2014). The CD4 count threshold for initiating treatment for asymptomatic adults was 350cells/mm3, but was subsequently increased to 500cells/mm3 in 2013, and ART was recommended for all HIV infected adults in 2017 (Federal Minstry of Health Ethiopia, 2017). The recommended type of ART has also been regularly revised; at the time of the study, a combination of tenofovir, lamivudine and efavirenz (TDF-3TC-EFV) was the preferred first line ART. Prophylaxes including co-trimoxazole and isoniazid preventive therapy have been routinely provided to prevent opportunistic infections. Treatment response was monitored by CD4 count measured every six months (Federal Ministry of Health Ethiopia, 2017). Evaluating the health benefits of ART for HIV-infected but asymptomatic Ethiopian women with high level of CD4 counts is important. To our knowledge, there are no previous Ethiopian studies addressing these questions. Therefore, the main objective of our study was to evaluate the clinical and immunological outcomes of asymptomatic HIV-infected pregnant women who initiated ART at different CD4 levels in Ethiopia.
    Materials and methods
    Result A total of 706 HIV-infected asymptomatic (WHO Stage I) women initiating ART during pregnancy were included in the analysis of occurrence of HIV-related clinical events. Background characteristics of women included (n=706) and excluded (n=220) from the analysis were largely similar, except that excluded women were younger and less compliant to treatment (Supplemental Table 1). Median age at ART initiation was 28 years (IQR: 25–30) and median gestational week at initiation was 20 weeks (IQR: 15–27). The majority of women (80.5%) initiated TDF-3TC-EFV. Women with baseline CD4 count ≥500cells/mm3 were younger and had higher hemoglobin level than women with CD4 below 500cells/mm3. The distributions of other background characteristics were largely similar across baseline CD4 levels (Table 1). The distribution of background characteristics of the subsample of women included in the evaluation of CD4 recovery at 6 months (n=668) and 12 months (n=297) after treatment initiation is presented in Supplemental Table 2.