Evidence map›Paper›PMID 38182720›Full record

ArticleScientific reports2024

Incidence and determinants of adverse events in individuals with HIV commencing Dolutegravir-based antiretroviral therapy in mainland Tanzania.

Adam Fimbo, Yonah H Mwalwisi, Kissa Mwamwitwa, Damas Matiko, Elirehema Mfinanga, Johnson Lyimo, Amon Sabasaba, Seth Missago, Elias Bukundi, Goodluck Gotora and 9 more

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 2 institutions in 1 country.

Adam FimboTanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania.
Yonah H MwalwisiTanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania.
Kissa MwamwitwaTanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania.
Damas MatikoTanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania.
Elirehema MfinangaTanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania.
Johnson LyimoWorld Health Organization, Dar Es Salaam, Tanzania.
Amon SabasabaDepartment of Epidemiology, School of Public Health, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Seth MissagoNational Institute for Medical Research, Headquarters, Dar Es Salaam, Tanzania.
Elias BukundiDepartment of Epidemiology, School of Public Health, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Goodluck GotoraTanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania.
Dorice RespickDepartment of Epidemiology, School of Public Health, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Alex NkayambaTanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania.
Emmanuel MasungaTanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania.
Rajabu Hussein MnkugweDepartment of Clinical Pharmacology, School of Biomedical Sciences, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Peter P KunambiDepartment of Clinical Pharmacology, School of Biomedical Sciences, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Castory MunishiDepartment of Pharmaceutics and Pharmacy Practice, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Christine Chiedza MusanhuWorld Health Organization, Dar Es Salaam, Tanzania.
Omary M S MinziDepartment of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Eulambius M MluguDepartment of Pharmaceutics and Pharmacy Practice, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. mlugusonlove@gmail.com.
Muhimbili University of Health and Allied Sciences · TZNational Institute for Medical Research · TZ

Funding

World Health Organization 001
6 · The paper itself

Abstract

Tanzania adopted a Dolutegravir (DTG)-based regimen as first-line treatment in 2019 following the World Health Organization recommendation. Data on the DTG safety profile from sub-Saharan Africa including Tanzania are limited. We investigated the incidence of DTG-related adverse events (AEs) and associated factors among people living with HIV (PLHIV) initiated on a DTG regimen. A prospective cohort study was conducted from 25 Care and Treatment Clinics in mainland Tanzania. PLHIV aged 12 years and above who were initiated on a DTG-based regimen were actively followed up for three months. The Cox regression model was used to determine the predictors of occurrence of AEs over time. A p-value of 0.05 was considered statistically significant. From January 2020 to June 2022, a cohort of 935 participants who were both newly diagnosed and ART-experienced who transitioned to a DTG-based regimen was enrolled. Out of 935 participants, 59 (6.3%) reported a total of 62 AEs. The most frequently experienced AE was skin itching and rashes (15/62; 24.2%). DTG-associated neuropsychiatric AEs were less common and included headache (6 [9.6%]) and sleep disturbances (3 [4.8%]). The overall incidence of occurrence of the first AEs was 96.7 per 1000 person-months [95% C.I: 74.4-125.7] with the highest incidence observed among the elderly (≥ 60 years). Individuals on WHO HIV Clinical Stage 2 had a 2.7 significantly higher risk of developing AEs (adjusted hazard ratio = 2.73, 95% CI = 1.46-5.12, p = 0.017). We report a low incidence of grade I (mild) and grade II (moderate) DTG-associated AEs suggesting that the regimen is generally safe in the population. Continued monitoring of DTG safety in the population is recommended.

Indexed as

Anti-Retroviral AgentsHIV InfectionsAgedDolutegravirHumansIncidenceProspective StudiesTanzaniaAnti-Retroviral AgentsDolutegravir

Identifiers

PMID38182720
PMCPMC10770041
OpenAlexW4390608138

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.