ABSTRACT
Background: There are few reports in the literature from sub-Saharan Africa (SSA) regarding antiretroviral-induced adverse drug reactions (ADRs). Antiretroviral therapy (ART) is now widely available in SSA, and ADRs during HIV infection are also frequent. In this study, we reported the frequency and risk factors of ART-induced ADRs in a Malian population.Methods: This prospective cohort study was performed in the HIV Care and Counseling Centre (CESAC) of Mali from 2011 to 2012. Adult patients infected with HIV and who had recently started ART were included and followed-up clinically Were included in this study, adult patients living with HIV and had recently started ART who were followed up for at least 6 months to determine the incidence of ADRs using Naranjo’s classification scale.Results: During this study, 357 (42.3%) patients presented ADRs (40.1% of our patients (n=338) experienced at least one ADR, and 2.2% (n=19) experienced at least two ADRs). The prevalence of ADRs by organ system was: 45.9% neurological (n=164); 29.4% metabolic (blood chemistry) (n=105); 15.4% hematological (n=55). High probable rate of ADR was observed as indicated by the Naranjo score in 83.7% of the cases. Zidovudine (AZT) and stavudine (d4T) use was identified as a risk factor for either anaemia or peripheral neuropathy whereas nevirapine (NVP) and female gender were risk factors for skin reactions. Patients with advance disease had the highest rate of ADRs compared to the others.Conclusions: Based on the Naranjo probability scale, our data show that ADRs such as peripheral neuropathy and anemia are very frequent. These ADR was linked to AZT and D4T. Our findings highlight the need for active monitoring, continuous pharmacovigilance of ART and change of some ART drug in this population.
ABSTRACT
This study aims to evaluate the in vivo antiviral, immunologic, clinical effects and safety of a supposedly anti-HIV phytotherapy, code-named R019 used for the treatment of HIV/AIDS. This is an open observational study, which involved 32 HIV-1 infected patients, who were followed over a 3-month period. The efficacy evaluation was based on CD4 count, determination of viral load and clinical status. The safety evaluation was based on renal and liver function tests, fasting lipid and glycaemia levels as well as the frequency of other adverse events. The CD4 values increased significantly (mean±SD, 99.03±22.87 cells/μL; P<0.001), as well as Weight and Karnofsky score (2.94±0.67 kg, p<0.001; 4.9, p=0.005 respectively). The viral load decreased significantly (0.91±0.12 log viral load, P<0.0001). R019 did not impair renal or liver functions. Improvement of creatinine clearance was observed (p=0.02). Hemoglobin levels increased (0.38±0.16 gr/dL) whereas cholesterol and glucose levels decreased under R019 treatment (p=0.031, p=0.018 respectively). Main adverse effects were recorded: polyuria (40.5%), drowsiness (21.4%), orexis (19.1%). Immunological, anti-viral and clinical status improved under R019 treatment and a good safety profile was observed for this compound. Further studies would be required to optimize its efficacy and to define its appropriateness for the treatment of HIV disease.