Evidence map›Paper›PMID 42162408›Full record

ArticleInfectious diseases and therapy2026

Efficacy and Safety of Switching to Dolutegravir/Lamivudine in Virologically Suppressed HIV-1 Infected Adults with TDF-Related Renal or Bone Toxicity.

Zhenyan Wang, Li Liu, Jun Chen, Jiangrong Wang, Yinzhong Shen, Tangkai Qi, Yang Tang, Wei Song, Jianjun Sun, Shuibao Xu and 4 more

Registry-linked trialAbstract read
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In one paragraph

Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05493969 (A Study Evaluating the Efficacy and Tolerability of Dolutegravir Plus Lamivudine in HIV Infected Adults Who Are Virologically Suppressed and With Evidence of TDF Toxicity), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT05493969 phase4unknown statusnot on this map

A Study Evaluating the Efficacy and Tolerability of Dolutegravir Plus Lamivudine in HIV Infected Adults Who Are Virologically Suppressed and With Evidence of TDF Toxicity

TypeinterventionalSponsorShanghai Public Health Clinical CenterRan2022 to 2026Enrolled100ConditionsAcquired Immunodeficiency SyndromeArmsDolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

Zhenyan WangDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.ORCID http://orcid.org/0000-0003-1402-6570
Li LiuDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Jun ChenDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Jiangrong WangDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Yinzhong ShenDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Tangkai QiDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Yang TangDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Wei SongDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Jianjun SunDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Shuibao XuDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Junyang YangDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Youming ChenDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Yueming ShaoDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
Renfang ZhangDepartment of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China. zhangrenfang@shaphc.org.

Funding

ViiV Healthcare 214248
6 · The paper itself

Abstract

introductionLong-term use of tenofovir disoproxil fumarate (TDF) is associated with renal tubular dysfunction and bone mineral loss. In virologically suppressed people living with HIV (PLWH), optimizing antiretroviral therapy requires maintaining viral suppression while minimizing cumulative drug-related toxicity. We therefore evaluated the efficacy and safety of switching to dolutegravir/lamivudine (DTG/3TC) in Chinese PLWH with TDF-related renal or bone toxicity.

methodsThis prospective, single-center, open-label cohort study enrolled adults with HIV-1 RNA < 40 copies/ml for ≥ 6 months on TDF-based regimens and evidence of TDF-associated renal or bone toxicity. Participants were switched to DTG/3TC and followed for 48 weeks. The primary endpoint was virological failure at week 48 (FDA Snapshot algorithm). Secondary endpoints included changes in CD4 + T-cell counts, renal tubular biomarkers, bone mineral density (BMD), metabolic parameters, and safety outcomes.

resultsOne hundred participants were enrolled; 91 completed the study per protocol. Median age was 45 years and 90% were male. At week 48, virological suppression was maintained in 90% of the intention-to-treat-exposed population and 99% of the per-protocol population. CD4 + T-cell counts increased significantly at week 48 (+ 77.4 cells/μl; p < 0.001). Markers of proximal tubular dysfunction improved significantly, including reductions in urinary β2-microglobulin-to-creatinine ratio, urine albumin-to-creatinine ratio, and urinary retinol-binding protein-to-creatinine ratio (all p < 0.001). BMD increased in the lumbar spine and hip (both p < 0.001). Modest weight gain (+ 2.17 kg) and small increases in total cholesterol and low-density lipoprotein cholesterol were observed at week 48.

conclusionsIn virologically suppressed Chinese PLWH with TDF-related renal or bone toxicity, switching to DTG/3TC maintained viral suppression and was associated with significant improvements in renal tubular and bone metabolic markers over 48 weeks. DTG/3TC represents a well-tolerated toxicity-driven switch strategy in routine clinical practice.

trial registrationClinicalTrial.gov ID: NCT05493969.

Indexed as

Bone toxicityDolutegravir/lamivudineHIVRenal toxicityTenofovir disoproxil fumarate

Identifiers

PMID42162408
PMCPMC13280112

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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.