antiretroviral treatment

Clinical monitoring of pediatric HIV treatment remains a major challenge in settings where drug resistance genotyping is not routinely available. As a result, our understanding of drug resistance, and its impact on subsequent therapeutic regimens available in these settings, remains limited. We investigate the prevalence and correlates of HIV-1 drug resistance among 94 participants of the Ethiopia Pediatric HIV Cohort failing first-line combination antiretroviral therapy (cART) using dried blood spot-based genotyping. Overall, 81% (73/90) of successfully genotyped participants harbored resistance mutations. Strikingly, 42% of resistant participants harbored resistance to all four nucleoside reverse transcriptase inhibitors recommended for second-line use in this setting, meaning that there are effectively no remaining cART options for these children. Longer cART duration and prior regimen changes were significantly associated with detection of drug resistance mutations. Replicate genotyping increased the breadth of drug resistance detected in 34% of cases, and thus is recommended for consideration when typing from blood spots. Implementation of timely drug resistance testing and access to newer antiretrovirals and drug classes are urgently needed to guide clinical decision-making and improve outcomes for HIV-infected children on first-line cART in Ethiopia.

Between December 2014 and September 2016, we conducted a prospective cohort study in eight health facilities in Ethiopia. Eligibility criteria included age 3 months-14 years; being on ART for not more than a month. Of 309 children, 304 were included, 52% were male. During 287.7 person-years of observation (PYO), 24 attritions were recorded, yielding an attrition rate of 8.3 per 100 PYO. Younger children, those from rural areas, and children with anaemia were at higher risk of attrition, especially during the early months of treatment, and therefore should be prioritized during treatment follow-up.

We interviewed 273 HIV-infected adolescents receiving antiretroviral therapy (ART) from three hospitals in Addis Ababa. The level of self-reported ART adherence among HIV-infected adolescents at the three hospitals was below the recommended threshold. Though earlier presentation of adolescents to care should be encouraged, more targeted adherence support should be planned for those who present at an early stage of their illness.

We implemented a group randomized controlled trial in 24 reproductive and child health clinics in eight districts in Mbeya region. Three months pre-intervention, we identified 1924 and 1226 patients established on antiretroviral therapy for six months or more in intervention and control clinics, respectively, of whom 83.4% and 86.9% had one or more post-intervention visits. The unadjusted rate of missed visits declined from 36.5% to 34.4% in intervention clinics and increased from 38.9% to 45.5% in control clinics following the intervention. Interrupted time series analyses demonstrated a net decrease of 13.7% (95% CI [-15.4,-12.1]) for missed visits at six months post-intervention. Similar differential changes were observed for visits missed by 3, 7, 15, or 60 days. Appointment-tracking and community outreach significantly improved appointment-keeping for women on antiretroviral therapy. The facility staff controlled their workload better, identified missing patients rapidly, and worked with existing community organizations. There is now enough evidence to scale up this approach to all antiretroviral therapy and Option B+ reproductive and child health clinics in Tanzania as well as to evaluate the intervention in medical clinics that treat other chronic health conditions.

The Ethiopian Paediatric HIV Cohort was established to identify clinical and laboratory predictors of virological treatment failure to ultimately develop a clinical–immunological prediction rule with area under the curve of >0.80 for detecting first-line antiretroviral therapy failure (ARTF). It will also assess the performance of the current WHO guidelines for detection of first-line ARTF in children. Using a prospective cohort design, HIV-infected children and adolescents below the age of 18 years are followed every 6 months with a set of clinical and laboratory parameters at 6 hospitals in southern Ethiopia. From October 2015 through April 2016, 628 children have been enrolled. The cohort will be completed in September 2017. The successful completion of this study will allow for better targeting of viral-load testing to those at highest risk in resource-poor settings and provide clinicians and policymakers with a practical prediction rule.

In Malawi, health-system constraints meant that only a fraction of people infected with human immunodeficiency virus (HIV) and in immediate need of antiretroviral treatment (ART) received treatment. In 2004, the Malawian Ministry of Health launched plans to scale-up ART nationwide, adhering to the principle of equity to ensure fair geographical access to therapy. A public health approach was used with standardized training and treatment and regular supervision and monitoring of the programme. Before the scale-up, an estimated 930 000 people in Malawi were HIV-infected, with 170 000 in immediate need of ART. About 3000 patients were on ART in nine clinics. By December 2015, cumulatively 872 567 patients had been started on ART from 716 clinics, following national treatment protocols and using the standard monitoring system. Strong national leadership allowed the ministry of health to implement a uniform system for scaling-up ART and provided benchmarks for implementation on the ground. New systems of training staff and accrediting health facilities enabled task-sharing and decentralization to peripheral health centres and a standardized approach to starting and monitoring ART. A system of quarterly supervision and monitoring, into which operational research was embedded, ensured stocks of drug supplies at facilities and adherence to national treatment guidelines.

Abstract Introduction: Active surveillance pharmacovigilance is a systematic approach to medicine safety assessment and health systems strengthening, but has not been widely implemented in low- and middle-income countries.

Abstract Purpose: Active surveillance pharmacovigilance systems better estimate the burden of adverse events (AEs) and can generate useful information on risk factors of AEs for more effective medicine use, especially in conjunction with introduction of new medicines and/or changes in treatment guidelines.

Abstract The scale-up of antiretroviral therapy (ART) in Malawi was based on a public health approach adapted to its resource-poor setting, with principles and practices borrowed from the successful tuberculosis control framework. From 2004 to 2015, the number of new patients started on ART increased from about 3,000 to over 820,000.

A cross-sectional survey was performed in 24 systems of care providing antiretroviral medications in Ethiopia, Kenya, Rwanda, Tanzania, and Uganda to examine current practices in monitoring rates of treatment adherence and defaulting. Only 20 of 48 facilities reported routinely measuring individual patient adherence levels; only 12 measured rates of adherence for the clinic population. The rules for determining which patients were included in the calculation of rates were unclear. Fourteen different definitions of treatment defaulting were in use. Facilities routinely gather potentially useful data, but the frequency of doing so varied widely. Individual and program treatment adherence and defaulting are not routinely monitored; when done, the operational definitions and methods varied widely, making comparisons across programs unreliable. There is a pressing need to determine which measures are the most feasible and reliable to collect, the most useful for clinical counseling, and most informative for program management.


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