Evidence map›Paper›PMID 41631851›Full record

Observational studyAntimicrobial agents and chemotherapy2026

Effectiveness and safety of ainuovirine plus lamivudine and tenofovir DF in virologically suppressed people living with HIV-1: the 48-week results of a multicenter, real-world study.

Shi Zou, Xiuhong Zhao, Qian Zhang, Yanling Xiao, Songjie Wu, Jie Liu, Yuting Tan, Qianhui Chen, Shihui Song, Miao Tan and 3 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Antimicrobial agents and chemotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

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

13 authors.

Shi Zou *Department of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, China.ORCID 0000-0003-0681-5123
Xiuhong Zhao *Department of Dermatology, Shandong Public Health Clinical Center, Shandong University, Shandong, China.
Qian Zhang *Qingshan District Center for Disease Control and Prevention, Wuhan, China.
Yanling Xiao *Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, China.
Songjie WuDepartment of Nosocomial Infection Management, Zhongnan Hospital of Wuhan University, Wuhan, China.
Jie LiuDepartment of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, China.
Yuting TanDepartment of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, China.
Qianhui ChenDepartment of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, China.
Shihui SongDepartment of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, China.
Miao TanDepartment of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, China.
Wei GuoDepartment of Pathology, Zhongnan Hospital of Wuhan University, Wuhan, China.ORCID 0000-0001-8686-3779
Chunmei WangDepartment of Dermatology, Shandong Public Health Clinical Center, Shandong University, Shandong, China.ORCID 0009-0007-4665-4914
Ke LiangDepartment of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, China.ORCID 0000-0003-0490-5328

Funding

Discipline Cultivation Funding, Zhongnan Hospital, Wuhan University ZNXKPY2021027
6 · The paper itself

Abstract

HIV-1 treatment has advanced with various antiretroviral regimens. Although efavirenz (EFV)-based regimens have been widely used, current guidelines recommend integrase strand transfer inhibitor (INSTI)-based therapy as first-line. However, INSTI may cause weight gain and adverse lipid changes, creating new unmet metabolic needs. Novel agents like ainuovirine (ANV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), may offer effective virological suppression (VS) with improved tolerability, but their long-term real-world safety and effectiveness remain unclear. This was a multicenter, retrospective observational cohort study. Virologically suppressed adults on a tenofovir disoproxil fumarate (TDF)/3TC+EFV regimen were either switched to TDF/3TC+ANV (ANV group) based on the physician's discretion or continued on TDF/3TC+EFV (EFV group). Baseline demographic and clinical data were collected, and participants were followed for 48 weeks. The primary effectiveness outcome was the proportion of patients achieving HIV-1 RNA levels below the limit of quantification (LOQ) at week 48. Secondary outcomes included absolute or percentage changes from baseline in CD4+ T-cell count, CD4+/CD8+ ratio. Key secondary safety outcomes included absolute changes from baseline in body weight, BMI, fasting lipid profiles (total cholesterol [TC], triglycerides [TG], high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C]), and parameters of liver and renal function. A total of 350 participants who completed the 48-week follow-up were included, comprising 170 patients in the ANV group and 180 patients who remained on EFV. At week 48, the proportion of VS was 96.5% in the ANV group and 96.1% in the EFV group (difference: 1.00 percentage points; 95% CI: -2.77 to 2.77), confirming non-inferiority. No significant differences in CD4+ T-cell recovery or CD4+/CD8+ ratios were observed. The ANV group experienced significantly less weight gain than the EFV group (estimated treatment difference [ETD]: -0.79 kg;

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsLamivudineReverse Transcriptase InhibitorsTenofovirAdultAlkynesCD4 Lymphocyte CountCyclopropanesFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeAlkynesAnti-HIV AgentsCyclopropanesLamivudineReverse Transcriptase InhibitorsTenofovirainuovirineefavirenzHIVlipid profilevirological suppressionweight gain

Identifiers

PMID41631851
PMCPMC12959095

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.