Effect of Dolutegravir and Multimonth Dispensing on Viral Suppression Among Children With HIV

Cyrus Mugo, MBChB, MPH, PhD; Bashir Zubayr, MBBS, MPH; Nnenna Ezeokafor, MPH; Babatunde Oyawola, MSc, MPH; David Ochedomi Ekele, MPH, PhD; Leila Madueke, MBBS, MPH, DM; Zipporah Kpamor, MD; Bazghina-werq Semo, MD, MSc, MPH

Disclosures

J Acquir Immune Defic Syndr. 2023;93(3):223-236. 

In This Article

Abstract and Introduction

Abstract

Background: Few studies in sub-Saharan Africa have assessed the impact of multimonth dispensing (MMD) of antiretroviral therapy (ART) and dolutegravir (DTG) beyond clinical trials among children with HIV (CWHIV). We assessed the effect of the 2 interventions on achieving undetectable viral load (VL) among CWHIV in the age group of 0–15 years in Nigeria.

Methods: We used longitudinal routine records and cross-sectional survey data from caregivers of a subsample of children. VLs were considered suppressed at <1000 copies/mL and undetectable at <50 copies/mL. Multimonth dispensing (MMD) was defined as ART refill for >84 days. The effect of MMD and DTG on VL levels and associations between social factors and VL were estimated using generalized linear models, reporting adjusted relative risks/prevalence ratios and 95% confidence intervals (CIs).

Results: Of 2490 CWHIV, 52% were male, with a median age of 10 years (interquartile ranges: 6–13) and a median duration on ART of 4.6 years (interquartile ranges: 2.8–7.1). Overall, 73% were on DTG and 55% received MMD. At baseline, 63% were suppressed, while 79% and 56% were suppressed and undetectable in their last VL, respectively. We found no differences in undetectable VL between those on MMD and not on MMD (adjusted relative risks: 1.05 [95% CI: 0.94–1.18]) and between those on DTG and not on DTG (1.07 [0.92–1.25]). In secondary analyses, poor adherence and being in a support group were associated with a lower likelihood of undetectable VL (adjusted prevalence ratios: 0.85 [95% CI: 0.74–0.96] and 0.81 [0.68–0.96], respectively).

Conclusion: MMD did not compromise treatment outcomes for CWHIV. Poor adherence, however, remains a barrier to achieving treatment targets.

Introduction

Approximately 1.8 million children in the age group of 0–15 years globally are living with HIV; more than 150,000 newly acquired HIV, and close to 100,000 died of AIDS-related causes in 2020.[1] Due to the prevention of mother-to-child transmission programs[2] and the "test and treat" approach,[3] there has been a significant reduction in the number of new HIV infections among children since 2010.[1] However for this age group, the UNAIDS 95-95-95 targets are far from being met,[1] with more than 40% of children with HIV (CWHIV) remaining undiagnosed globally,[4] close to 50% of those diagnosed needing to be initiated on antiretroviral therapy (ART), and for those on treatment, more than a third not achieving viral suppression (viral load <1000 copies/mL).[5] Nigeria had an estimated 130,000 CWHIV in 2020, with only 46% on ART,[1] and 82% of those on treatment having achieved viral suppression.[6]

Previous studies have assessed the influence of some factors on viral suppression in children. For example, certain antiretroviral drugs have been shown to be more effective among children. Children on non-nucleoside reverse transcriptase inhibitors (NNRTIs), especially nevirapine, had poorer viral suppression compared with those on protease inhibitor (PI) such as lopinavir.[7,8] Informed by results of clinical trials, the current World Health Organization and Nigeria treatment guidelines[9,10] recommend the more efficacious[7,8,11] dolutegravir (DTG)–based regimen as the first-line therapy for children. Globally, roll out of DTG-based pediatric regimen began in 2018,[12] with the more palatable formulations for younger children introduced in 2020.[13] The Nigeria National Data Repository reported that approximately 76% of CWHIV were initiated or switched to DTG-based regimen by December 2021.[6] Due to challenges accessing viral load testing and to avoid market fragmentation, the guidelines recommended switching patients to DTG regardless of their viral load levels as long as they were clinically stable.[14]

Few studies, beyond the clinical trials, have been conducted in sub-Saharan Africa to assess the impact of DTG on viral suppression among children. Despite having small sample sizes, these studies have affirmed the higher efficacy of DTG in viral suppression.[15,16] Beyond ART, other studies have shown viral suppression in CWHIV is associated with younger age, longer ART duration, female sex, and caregiver viral suppression.[17,18]

Differentiated service delivery (DSD) is a patient-centered strategy that optimizes HIV services to better serve the needs of people living with HIV and reduce demands on the health system.[19] DSD practices include multimonth dispensing (MMD) of ART, where patients get at least 3 months of treatment during a clinic visit or in their communities through community-based drug distribution models.[20] The patients typically offered MMD were clinically stable with a suppressed viral load.[21] While DSD approaches have been in place and have shown to improve adult patient treatment experiences and outcomes,[22–26] only a few studies from countries in sub-Saharan Africa have described DSD models for children and even fewer have reported on the impact of DSD practices on viral suppression.[27] Similar to other countries in sub-Saharan Africa, Nigeria adopted DSD through MMD and other models for most patients when COVID-19 restrictions were introduced in March 2020. The models continued after the restrictions were lifted due to high satisfaction from clients and providers.[20,28–30] The objective of this study was to determine the effect of DTG-based regimen, MMD, and other individual-level/household-level factors on viral suppression among children aged 0–15 years in Nigeria.

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