Browsing by Author "Muula G"

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Associations of inter-annual rainfall decreases with subsequent HIV outcomes for persons with HIV on antiretroviral therapy in Southern Africa: a collaborative analysis of cohort studies.
(2023-Dec-19) Trickey A; Johnson LF; Fung F; Bonifacio R; Iwuji C; Biraro S; Bosomprah S; Chirimuta L; Euvrard J; Fatti G; Fox MP; Von Groote P; Gumulira J; Howard G; Jennings L; Kiragga A; Muula G; Tanser F; Wagener T; Low A; Vickerman P
BACKGROUND: Periods of droughts can lead to decreased food security, and altered behaviours, potentially affecting outcomes on antiretroviral therapy (ART) among persons with HIV (PWH). We investigated whether decreased rainfall is associated with adverse outcomes among PWH on ART in Southern Africa. METHODS: Data were combined from 11 clinical cohorts of PWH in Lesotho, Malawi, Mozambique, South Africa, Zambia, and Zimbabwe, participating in the International epidemiology Databases to Evaluate AIDS Southern Africa (IeDEA-SA) collaboration. Adult PWH who had started ART prior to 01/06/2016 and were in follow-up in the year prior to 01/06/2016 were included. Two-year rainfall from June 2014 to May 2016 at the location of each HIV centre was summed and ranked against historical 2-year rainfall amounts (1981-2016) to give an empirical relative percentile rainfall estimate. The IeDEA-SA and rainfall data were combined using each HIV centre's latitude/longitude. In individual-level analyses, multivariable Cox or generalized estimating equation regression models (GEEs) assessed associations between decreased rainfall versus historical levels and four separate outcomes (mortality, CD4 counts < 200 cells/mm RESULTS: Among 270,708 PWH across 386 HIV centres (67% female, median age 39 [IQR: 32-46]), lower rainfall than usual was associated with higher mortality (adjusted Hazard Ratio: 1.18 [95%CI: 1.07-1.32] per 10 percentile rainfall rank decrease) and unsuppressed viral loads (adjusted Odds Ratio: 1.05 [1.01-1.09]). Levels of rainfall were not strongly associated with CD4 counts < 200 cell/mm CONCLUSIONS: Decreased rainfall could negatively impact on HIV treatment behaviours and outcomes. Further research is needed to explore the reasons for these effects. Interventions to mitigate the health impact of severe weather events are required.
Cardiovascular Involvement in Tuberculosis Patients Treated in Southern Africa.
(2025-Jan) Samim D; Muula G; Banholzer N; Chibomba D; Xulu S; Bolton C; Evans D; Perrig L; De Marchi S; Günther G; Egger M; Pilgrim T; Fenner L
BACKGROUND: Tuberculosis (TB) is the leading cause of death among people with HIV and a major global health challenge. Subclinical cardiovascular manifestations of TB are poorly documented in high TB and HIV burden countries. OBJECTIVES: The purpose of this study was to quantify the prevalence of cardiovascular involvement in TB patients and investigate changes after completion of anti-TB treatment. METHODS: HIV-positive and HIV-negative patients diagnosed with pulmonary TB between October 2022 and November 2023 were enrolled from 2 tertiary care hospitals in Zambia and South Africa. Standardized transthoracic echocardiography (TTE) was conducted at TB diagnosis and after 6 months of anti-TB treatment. Cross-sectional and longitudinal analyses assessed pericardial effusion, thickening, or calcification, with and without signs of pericardial constriction. RESULTS: A total of 286 TB patients (218 [76%] men, 109 [38%] people with HIV, median age 35 years) underwent TTE at TB diagnosis, of whom 105 participants had a second TTE after completion of treatment. At TB diagnosis, 134 (47%) had pericardial effusions, 86 (30%) thickening, 7 (2%) calcifications, 103 (42%) signs of constriction, and 13 (12%) had definite diagnosis of constriction. After TB treatment, pericardial effusions (47% vs 16%, CONCLUSIONS: Cardiac involvement is frequent in newly diagnosed TB patients. Early pericardial changes may be reversed with anti-TB treatment. Echocardiographic screening facilitates early detection and timely management of cardiovascular involvement in TB patients.
Cohort profile: Noncommunicable diseases and ideal cardiovascular health among people living with and without HIV in Zambia and Zimbabwe (NCDzz cohort).
(2025-Feb-07) Chihota BV; Mandiriri A; Muula G; Banda E; Shamu T; Bolton-Moore C; Chimbetete C; Bosomprah S; Wandeler G
PURPOSE: The NCDzz study is a prospective cohort of people living with and without HIV attending primary care clinics in Zambia and Zimbabwe and was established in 2019 to understand the intersection between noncommunicable diseases (NCDs) and HIV in Southern Africa. Here, we describe the study design and population and evaluate their ideal cardiovascular health (ICVH) using the Life's Simple 7 (LS7) score according to the American Heart Association. PARTICIPANTS: Antiretroviral therapy-naïve people living with HIV (PLWH) and people living without HIV (PLWOH) 30 years or older were recruited from three primary care clinics in Lusaka and Harare, and underwent comprehensive clinical, laboratory and behavioural assessments. All study measurements are repeated during yearly follow-up visits. PLWOH were recruited from the same neighbourhoods and had similar socioeconomic conditions as PLWH. FINDINGS TO DATE: Between August 2019 and March 2023, we included 1100 adults, of whom 618 (56%) were females and 539 (49%) were PLWH. The median age at enrolment was 39 years (IQR 34-46 years). Among 1013 participants (92%) with complete data, the median LS7 score was 11/14 (IQR 10-12). Overall, 60% of participants met the criteria of ICVH metrics (5-7 ideal components) and among individual components of the LS7, more females had poor body mass index (BMI) than males, regardless of HIV status (27% vs 3%, p<0.001). Our data show no apparent difference in cardiovascular health determinants between men and women, but high BMI in women and overall high hypertension prevalence need detailed investigation. Untreated HIV (OR: 1.36 (IQR 1.05-1.78)) and being a Zambian participant (OR: 1.81 (IQR 1.31-2.51)) were associated with having ICVH metrics, whereas age older than 50 years (OR: 0.46 (IQR 0.32-0.65)) was associated with not having ICVH metrics. FUTURE PLANS: Our study will be regularly updated with upcoming analyses using prospective data including a focus on arterial hypertension and vascular function. We plan to enrich the work through conducting in-depth assessments on the determinants of cardiovascular, liver and kidney end-organ disease outcomes yearly. Additionally, we seek to pilot NCD interventions using novel methodologies like the trials within cohorts. Beyond the initial funding support, we aim to collect at minimum yearly data for an additional 5-year period.
Drug Resistance in People With Viremia on Dolutegravir-based Antiretroviral Therapy in Sub-Saharan Africa: The DTG RESIST Study.
(2025-May-20) Loosli T; Moore CB; Buzaalirwa L; Byakwaga H; Çelikağ İ; Chimbetete C; Ebasone PV; Giandhari J; Han N; Huwa J; Kasozi C; Mafoua A; Messou E; Minga A; Muula G; Muyindike W; Ndala ACM; Sauermann M; Semeere A; Singh L; Kouyos RD; Lessells R; Egger M
Dolutegravir resistance is an increasing concern. An analysis of the DTG RESIST study found that among 227 integrase sequences from 7 African countries (all non-B subtypes), 59 (26.0%) had at least 1 major drug resistance mutation (primarily G118R and E138A/K/T), with 49 (21.6%) predicted to have high-level resistance to dolutegravir.
Elimination of Viral Hepatitis in Low and Middle-Income Countries: Epidemiological Research Gaps.
(2021-Sep) Jaquet A; Muula G; Ekouevi DK; Wandeler G
PURPOSE OF REVIEW: The purpose of our review was to summarize current recommendations on testing strategies, antiviral therapy eligibility and monitoring, and prevention of mother-to-child transmission of chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, and to highlight major research gaps in low and middle-income countries (LMIC), with a particular focus on sub-Saharan Africa (SSA). RECENT FINDINGS: While data on the prevalence of HBV and HCV infections in LMIC are increasing, current knowledge on liver-related complications as well as on treatment outcomes remains limited. Furthermore, very little information is available on the feasibility and cost-effectiveness of large-scale testing and management strategies in high-prevalence settings. The availability of policy-relevant data is particularly scarce in SSA, which accounts for a significant part of the global burden of chronic viral hepatitis. SUMMARY: Current recommendations on the management and monitoring of chronic viral hepatitis rely mainly on data from high-income settings. The global elimination of viral hepatitis will only be achieved if prevention, testing, and treatment strategies tailored to specific LMIC are implemented. In order to inform scalable and cost-effective interventions, dedicated research initiatives have to be undertaken. Future studies will have to include the evaluation of innovative testing strategies, the validation of simplified methods to diagnose liver cirrhosis and hepatocellular carcinoma, and the monitoring of long-term treatment outcomes and toxicity. In addition, national plans to achieve the elimination of HBV mother-to-child transmission are urgently needed, including effective ways to test pregnant women, treat those who are eligible, and ensure birth dose vaccination is given to all newborns.
Field evaluation of nanopore targeted next-generation sequencing to predict drug-resistant tuberculosis from native sputum in South Africa and Zambia.
(2025-Mar-12) Schwab TC; Joseph L; Moono A; Göller PC; Motsei M; Muula G; Evans D; Neuenschwander S; Günther G; Bolton C; Keller PM; Ramette A; Egger M; Omar SV; Fenner L
Rapid and comprehensive drug susceptibility testing (DST) is essential for diagnosing and treating drug-resistant tuberculosis effectively, and next-generation sequencing can be an effective genotypic DST method. We implemented and evaluated the performance of a nanopore targeted sequencing assay, called the Tuberculosis Drug Resistance Test (TBDR, Oxford Nanopore Diagnostics, Ltd., United Kingdom), which predicts drug resistance to 16 TB drugs, at a South African reference laboratory and a district diagnostic laboratory in Zambia. We compared the sequencing success rates between unprocessed and decontaminated sputum samples and determined the diagnostic accuracy against local DST (Xpert MTB/RIF Ultra, Xpert MTB/XDR, and BD BACTEC MGIT phenotypic DST). We prospectively sequenced 236 samples and have 148 samples with sequencing results from unprocessed and decontaminated sputum. We obtained successful sequencing results from 66.4% (94/148) unprocessed sputum samples and 75% (111/148) decontaminated samples. Sequencing success rates at the two sites differed, with 50.7% (36/71) successful sequencing results from unprocessed sputum in Zambia and 75.3% (58/77) in South Africa. Samples with "low" bacterial load, measured by Xpert MTB/RIF Ultra, tended to produce fewer successful sequencing results. TBDR sequencing predicted resistances in 48 samples, detecting resistance for rifampicin (
Liver steatosis and metabolic dysfunction-associated fatty liver disease among HIV-positive and negative adults in urban Zambia.
(2022-Jul) Chihota BV; Riebensahm C; Muula G; Sinkala E; Chilengi R; Mulenga L; Bosomprah S; Vinikoor MJ; Bolton-Moore C; Egger M; Rauch A; Berzigotti A; Wandeler G
INTRODUCTION: The growing importance of non-communicable diseases (NCDs) and high HIV prevalence in urban African settings may increase the burden of metabolic dysfunction-associated fatty liver disease (MAFLD). We assessed liver steatosis among HIV-positive and negative adults in urban Zambia. METHODS: Adults 30 years and older who were newly diagnosed with HIV, or tested HIV-negative at two primary care clinics in Lusaka, Zambia, were assessed for liver steatosis. Cardiometabolic data were collected through comprehensive clinical and laboratory assessments. Transient elastography was performed to measure controlled-attenuation parameter (≥248 dB/m). We used multivariable logistic regression models to determine the factors associated with the presence of steatosis. RESULTS: We enrolled 381 patients, including 154 (40%) antiretroviral therapy-naïve people living with HIV (PLWH) with a median CD4+ count of 247 cells/mm CONCLUSIONS: The prevalence of liver steatosis in this urban cohort of HIV-positive and negative adults in Zambia was low, despite a large proportion of patients with high BMI and central obesity. Our study is among the first to report data on MAFLD among adults in Africa, demonstrating that metabolic risk factors are key drivers of liver steatosis and supporting the adoption of the criteria for MAFLD in African populations.
Long-term Hepatitis B and Liver Outcomes Among Adults Taking Tenofovir-Containing Antiretroviral Therapy for HBV/HIV Coinfection in Zambia.
(2024-Jun-14) Vinikoor MJ; Hamusonde K; Muula G; Asombang M; Riebensahm C; Chitundu H; Sunkuntu-Sichizya V; Bhattacharya D; Sinkala E; Lauer G; Chung R; Mbewe W; Egger M; Bosomprah S; Wandeler G
BACKGROUND: Long-term outcomes of tenofovir-containing antiretroviral therapy (ART) for hepatitis B virus (HBV)/human immunodeficiency virus (HIV) coinfection were evaluated in Zambia. METHODS: A prospective cohort of adults with HIV and hepatitis B surface antigen (HBsAg)-positivity was enrolled at ART initiation. On tenofovir-containing ART, we ascertained HBV viral load (VL) non-suppression, alanine aminotransferase (ALT) elevation, serologic end-points, progression of liver fibrosis based on elastography, and hepatocellular carcinoma (HCC) incidence. We also described a subgroup (low HBV VL and no/minimal fibrosis at baseline) that, under current international guidelines, would not have been treated in the absence of their HIV infection. RESULTS: Among 289 participants at ART start, median age was 34 years, 40.1% were women, median CD4 count was 191 cells/mm3, 44.2% were hepatitis B e antigen-positive, and 28.4% had liver fibrosis/cirrhosis. Over median 5.91 years of ART, 13.6% developed HBV viral non-suppression, which was associated with advanced HIV disease. ALT elevation on ART was linked with HBV VL non-suppression. Regression of fibrosis and cirrhosis were common, progression to cirrhosis was absent, and no cases of HCC were ascertained. HBsAg seroclearance was 9.4% at 2 and 15.4% at 5 years, with higher rates among patients with low baseline HBV replication markers. CONCLUSIONS: Reassuring long-term liver outcomes were ascertained during tenofovir-based ART for HBV/HIV coinfection in Zambia. Higher than expected HBsAg seroclearance during ART underscores the need to include people with HIV in HBV cure research.
Mental, physical, and respiratory health in people with tuberculosis in Southern Africa: a multi-country cohort analysis.
(2025-Aug-20) Banholzer N; Muula G; Mureithi F; Evans D; Huwa J; Rafael I; Kunzekwenyika C; Jinga N; Fernando A; Thawani A; Schmutz R; Bolton C; Günther G; Egger M; Haas AD; Sweetland AC; Ballif M; Fenner L
BACKGROUND: Tuberculosis (TB) affects people's quality of life (QoL). We prospectively monitored physical and mental health-related QoL over time in people with TB in the Southern African region with a high HIV and TB burden. METHODS: Adults aged ≥ 15 years with pulmonary TB were enrolled in five cohorts in Malawi, Mozambique, South Africa, Zambia, and Zimbabwe from October 2022 to September 2024. We assessed six QoL outcomes using validated instruments at the start (baseline), end of treatment, and 6 months post-treatment: symptoms of depression (PHQ-9), mental and physical health (SF-12 mental, SF12-MC, SF-12 physical component, SF12-PC), physical fitness (6-Minute Walk Test, 6MWT; 1-min Sit-To-Stand Test, STST), and respiratory health (Saint-George-Respiratory-Questionnaire, SGRQ). Missing QoL scores were imputed with multivariate imputation by chained equations. We compared the proportion of participants with impaired QoL, defining impairment based on outcome-specific cut-off values. We also estimated changes in QoL scores and examined their associations with baseline characteristics using Bayesian multivariable regression models. RESULTS: We included 1438 participants with a median follow-up of 344 days (interquartile range [IQR] 183-373). The median age was 39 years (IQR 30-50); 67% were male, and 39% living with HIV. At baseline, 49% had symptoms of depression, 73% had impaired mental health and 92% impaired physical health-related QoL, 68-74% had reduced physical fitness (68%: 6MWT, 74%: STST), and 78% impaired respiratory health. All QoL outcomes improved by the end of treatment, notably depressive symptoms (48% to 5%), mental health-related QoL (73% to 28%), and respiratory health (78% to 11%). Most QoL impairments continued to decrease post-treatment, especially physical and respiratory health; depressive symptoms remained below 5%. Across QoL domains and study visits, better outcomes were associated with age < 30 (83% probability), and worse outcomes with female gender (86%) and a prior TB history (89%). Living with HIV and alcohol drinking were associated with worse QoL only at baseline (88% and 87%). CONCLUSIONS: TB negatively impacts QoL across physical, mental, and social domains, including post-treatment. The study highlights the need for integrated mental and physical healthcare and rehabilitation during TB treatment and beyond, especially for high-risk populations, to address the long-term impact of TB on QoL.
Screening for hepatocellular carcinoma among adults with HIV/HBV co-infection in Zambia: a pilot study.
(2022-Mar) Riebensahm C; Chitundu H; Muula G; Chihota B; Sinkala E; Sunkutu V; Maurer MH; Dufour JF; Berzigotti A; Egger M; Bolton-Moore C; Vinikoor M; Wandeler G
BACKGROUND AND AIMS: Chronic hepatitis B virus (HBV) infection is the main cause of hepatocellular carcinoma (HCC) in sub-Saharan Africa (SSA). An HCC screening initiative was piloted in an established cohort of individuals co-infected with human immunodeficiency virus (HIV) and HBV on antiretroviral therapy (ART) at two outpatient clinics in Lusaka, Zambia. METHODS: All patients underwent abdominal ultrasound (AUS) and transient elastography. RESULTS: Among 279 patients co-infected with HIV/HBV, 165 (59.1%) were men, median age was 34 years [interquartile range (IQR) 28-39 years] and median CD4 count was 246 cells/µL (IQR 112-355 cells/µL) at ART initiation. While 102 (55.7%) individuals had elevated transaminases, 114 (59.7%) had HBV levels >2000 IU/mL and 59 (24.6%) had significant fibrosis. At their first AUS measurement, 75 (26.9%) participants had hepatomegaly and 69 (24.7%) had periportal fibrosis. Five patients had a liver lesion >1 cm, an indication for confirmatory imaging. CONCLUSIONS: In one of the first HCC screening initiatives in SSA, 2% of patients co-infected with HIV/HBV had significant liver lesions, and one-quarter had findings suggestive of schistosomiasis-induced liver damage.
The long-term impact of the COVID-19 pandemic on tuberculosis care and infection control measures in anti-retroviral therapy (ART) clinics in low- and middle-income countries: a multiregional site survey in Asia and Africa.
(2025-Mar-24) Ballif M; Banholzer N; Perrig L; Avihingsanon A; Nsonde DM; Obatsa S; Muula G; Komena E; Uemura H; Lelo P; Otaalo B; Huwa J; Gouéssé P; Kumarasamy N; Brazier E; Michael D; Rafael I; Ramdé R; Somia IKA; Yotebieng M; Diero L; Euvrard J; Ezechi O; Fenner L
BACKGROUND: The COVID-19 pandemic challenged healthcare systems, particularly in settings with high infectious disease burden. We examined the postpandemic long-term impacts of COVID-19 on tuberculosis (TB) services at anti-retroviral therapy (ART) clinics in lower-income countries. METHODS: Using standardised online questionnaires, we conducted a cross-sectional site survey among ART clinics providing TB services in Africa and Asia from July to September 2023 (site-level information and number of TB diagnoses and tests). RESULTS: Of 45 participating ART clinics, 32 (71%) were in Africa and 13 (29%) in Asia. During the COVID-19 pandemic (2020-2022), 43 (96%) clinics reported implementing social distancing or separation measures, 39 (87%) personal protections for staff members and 32 (71%) protections for patients. Infection control measures were in place in 45% of the clinics before the pandemic (until 2019), 23% introduced measures during the pandemic and 15% maintained them after the pandemic (after 2022). Service provision was affected during the pandemic in 33 (73%) clinics, including TB services in 22 (49%) clinics. TB service restrictions were addressed by introducing changes in directly observed therapy provision in 8 (18%) clinics, multimonth TB drug dispensing in 23 (51%), telehealth services in 25 (56%) and differentiated service delivery in 19 (42%). These changes were sustained after the pandemic at 4 (9%), 11 (24%), 17 (38%) and 12 (27%) clinics, respectively. Compared with 2018-2019, the number of TB diagnoses decreased sharply in 2020-2021 and improved after the pandemic. CONCLUSIONS: COVID-19 affected TB care services in ART clinics in Africa and Asia. This was paralleled by a reduction in TB diagnoses, which partly resumed after the pandemic. Infection control measures and alternative modes of service delivery were adopted during the pandemic and only partially maintained. Efforts should be made to sustain the lessons learnt during the COVID-19 pandemic, particularly approaches that reduce the risk of transmission of infectious diseases, including TB, in ART clinics.
Tuberculosis Diagnosis, Treatment, and Prevention Services for Children Living with HIV in Low- and Middle-Income Countries: A Multiregional Site Survey.
(2025-Jun-16) Laycock K; Technau KG; Lelo P; Jantarabenjakul W; Yonaba C; Pinto J; Menser M; Maruri F; Odhiambo F; Rambiki E; Babakazo P; Nguyen VL; Folquet M; Machado DM; Kalema N; Muula G; Brazier E; Nguyen DQ; Dame J; Luque MT; Semeere A; Eley B; Yotebieng M; Kariminia A; Rouzier V; Byakwaga H; Marcy O; Enane LA
BACKGROUND: Tuberculosis (TB) remains a leading cause of morbidity and mortality for children living with HIV (CLHIV), with gaps in TB screening, diagnostics, management, and TB preventive therapy (TPT). We investigated reported practices in these domains at sites caring for CLHIV in low- and middle-income countries (LMICs) within the International Epidemiology Databases to Evaluate AIDS (IeDEA) consortium. METHODS: We implemented a site survey from September 2020 to February 2021, querying pre-pandemic practices. This analysis included sites in LMICs providing care for CLHIV that diagnosed TB in 2019. We analyzed responses using descriptive statistics and assessed regional differences using Fisher's exact or chi-square tests. RESULTS: Of 238 IeDEA sites, 227 (95%) responded and 135 met the inclusion criteria. Most (90%) reported screening for TB at HIV care enrollment. Access to diagnostics varied significantly by region, including nucleic acid amplification testing (NAAT, range 67-100%), mycobacterial culture (range 43%-83%), and drug susceptibility testing (range 30%-82%) (P < .001). On-site TB treatment was high (90%). Reported stock-outs occurred for isoniazid (23/116, 20%) and other TB medications (11/114, 9.6%, range 0%-33%, P = .008). TPT provision ranged 50%-100% (P < .001). Six months of isoniazid was the most common TPT regimen for children (88%). Shorter TPT regimens were uncommon (0.9%-2.8%), as were regimens for multidrug-resistant TB exposure (4.6%). CONCLUSIONS: Overall reported availability of NAAT and integrated TB/HIV treatment for CLHIV cared for at these IeDEA sites in LMICs is encouraging but varies by context. Heterogeneous implementation gaps remain-particularly for drug susceptibility testing, TPT delivery, and TPT regimens-which may impede TB prevention, management, and successful outcomes for CLHIV, warranting continued close attention over time and as global TB care guidelines and services evolve.
Virologic Failure and Drug Resistance After Programmatic Switching to Dolutegravir-based First-line Antiretroviral Therapy in Malawi and Zambia.
(2025-Feb-05) Skrivankova VW; Huwa J; Muula G; Chiwaya GD; Banda E; Buleya S; Chihota B; Chintedza J; Bolton C; Tweya H; Kalua T; Hossmann S; Kouyos R; Wandeler G; Egger M; Lessells RJ
BACKGROUND: People with human immunodeficiency virus (PWH) on first-line, nonnucleoside reverse-transcriptase inhibitor-based antiretroviral therapy (ART) were routinely switched to tenofovir-lamivudine-dolutegravir. We examined virologic outcomes and drug resistance in ART programs in Malawi, where switching was irrespective of viral load, and Zambia, where switching depended on a viral load <1000 copies/mL in the past year. METHODS: We compared the risk of viremia (≥400 copies/mL) at 1 and 2 years by viral load at switch and between countries using exact methods and logistic regression adjusted for age and sex. We performed HIV-1 pol Sanger sequencing on plasma samples with viral load ≥1000 copies/mL. RESULTS: A total of 2832 PWH were eligible (Malawi 1422, Zambia 1410); the median age was 37 years, and 2578 (91.0%) were women. At switch, 77 (5.4%) were viremic in Malawi and 42 (3.0%) in Zambia (P = .001). Viremia at switch was associated with viremia at 1 year (adjusted odds ratio (OR), 6.15; 95% confidence interval [CI], 3.13-11.4) and 2 years (7.0; 95% CI, 3.73-12.6). Viremia was less likely in Zambia than in Malawi at 1 year (OR, 0.55; 0.32-0.94) and 2 years (OR, 0.33; 0.18-0.57). Integrase sequencing was successful for 79 of 113 eligible samples. Drug resistance mutations were found in 5 PWH (Malawi 4, Zambia 1); 2 had major mutations (G118R, E138K, T66A and G118R, E138K) leading to high-level dolutegravir resistance. CONCLUSIONS: Restricting switching to dolutegravir-based ART to PWH with a viral load <1000 copies/mL may reduce subsequent viremia and, consequently, the emergence of dolutegravir drug resistance mutations. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov (NCT04612452).