Evidence map›Paper›PMID 33021066›Full record

Observational studyHIV medicine2020

Efficacy and safety of a single-tablet regimen containing tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg and efavirenz 400 mg as a switch strategy in virologically suppressed HIV-1-infected subjects on nonnucleoside reverse transcriptase inhibitor-containing first-line antiretroviral therapy in Pune, India.

A Dravid, T P Betha, A K Sharma, R Gawali, U Mahajan, M Kulkarni, C Saraf, S Kore, M Dravid, N Rathod

Open access · bronzeAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in HIV medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 45% 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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
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

10 authors at 7 institutions in 1 country.

A DravidDepartment of Medicine, Ruby Hall Clinic, Pune, Maharashtra, India.ORCID 0000-0002-1909-7530
T P BethaDepartment of Medicine, Poona Hospital and Research Centre, Pune, Maharashtra, India.
A K SharmaDepartment of Medicine, Poona Hospital and Research Centre, Pune, Maharashtra, India.
R GawaliDepartment of Medicine, Poona Hospital and Research Centre, Pune, Maharashtra, India.
U MahajanDepartment of Biostatistics, VMK Diagnostics Private Limited, Pune, Maharashtra, India.
M KulkarniDepartment of Medicine, Ruby Hall Clinic, Pune, Maharashtra, India.
C SarafDepartment of Pathology, VMK Diagnostics Private Limited, Pune, Maharashtra, India.
S KoreDepartment of Dermatology, Ashwini Sahakari Rugnalaya and Research Centre, Solapur, Maharashtra, India.
M DravidInfectious Disease Clinic, Dhule, Maharashtra, India.
N RathodDepartment of Medicine, Apex Hospital, Kolhapur, Maharashtra, India.
ACE Hospital · INRuby Hall Clinic · INACPM Dental College and Hospital · INAshwini Hospital · INRajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital Kolhapur · INShri Vile Parle Kelavani Mandal · INTilak Maharashtra Vidyapeeth · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesAs per National AIDS Control Organization (NACO) estimates, there are 2.1 million people living with HIV (PWH) in India, of whom 1.2 million are on first-line antiretroviral therapy (ART). This study explored the use of a single-tablet regimen containing tenofovir disoproxil fumarate 300 mg + lamivudine 300 mg + efavirenz 400 mg (TLE400 STR) as a first-line switch strategy in PWH in Pune, India.

methodsThis retrospective cohort study was conducted in private sector ART clinics in three tertiary-level hospitals in Pune, India. PWH > 12 years of age (n = 502) who initiated first-line ART (predominantly TLE600 STR), completed ≥ 6 months of follow-up and achieved virological suppression [plasma viral load (VL) < 1000 HIV-1 RNA copies/mL] were identified and switched to TLE400 STR. The virological and immunological efficacy of TLE400 STR at 6 and 12 months of follow-up were noted. Grade 3/4 adverse events (especially efavirenz-related neuropsychiatric adverse events) leading to regimen discontinuation were also noted.

resultsOf 502 PWH who switched to TLE400 STR, complete virological suppression (VL < 20 copies/mL) was maintained in more than 97% of patients at follow-up. TLE400 STR was successful in maintaining CD4 counts within the range observed at the start of the regimen. Grade 3/4 adverse events leading to TLE400 STR discontinuation were seen in 11 (2.2%) patients. Virological failure (VL > 1000 copies/mL) and treatment regimen failure were seen in six (1.2%) and 49 (9.8%) subjects, respectively.

conclusionsTLE400 STR exhibits excellent efficacy and safety as a switch strategy and should be introduced in the Indian National ART Program, especially for PWH who are virologically suppressed on TLE600 STR.

Indexed as

AdultAlkynesBenzoxazinesCD4 Lymphocyte CountCyclopropanesDrug CombinationsFemaleHIV-1HIV InfectionsHumansIndiaLamivudineMaleMiddle AgedPrivate SectorRetrospective StudiesAlkynesBenzoxazinesCyclopropanesDrug CombinationsefavirenzLamivudineReverse Transcriptase InhibitorsTabletsTenofovirantiretroviral therapy optimizationcost‐effectivenessefavirenz 400 mgIndiasingle‐tablet regimen

Identifiers

PMID33021066
PMCPMC7539943
OpenAlexW3044777183

What OpenQuestion holds

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LicenceCC BY-NC
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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.