Evidence map›Paper›PMID 20023437›Full record

Trial reportAIDS (London, England)2010

Non-nucleoside reverse transcriptase inhibitor outcomes among combination antiretroviral therapy-treated adults in Botswana.

C William Wester, Ann Muir Thomas, Hermann Bussmann, Sikhulile Moyo, Joseph M Makhema, Tendani Gaolathe, Vladimir Novitsky, Max Essex, Victor deGruttola, Richard G Marlink

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 6 pooled it
2.2field-weighted citation impact, top 13% 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

24 citing papers in PubMed, 6 syntheses or guidelines pooled it, 39 citations in OpenAlex.

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  12. Association ofPharmacogenomics and personalized medicine · 2021
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  16. Contemporary review of drug-induced pancreatitis: A different perspective.World journal of gastrointestinal pathophysiology · 2014
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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

10 authors at 4 institutions in 3 countries.

C William WesterBotswana-Harvard School of Public Health AIDS Initiative Partnership for HIV Research and Education (BHP), Gaborone, Botswana.
Ann Muir Thomas
Hermann Bussmann
Sikhulile Moyo
Joseph M Makhema
Tendani Gaolathe
Vladimir Novitsky
Max Essex
Victor deGruttola
Richard G Marlink
Harvard University · USBotswana Harvard AIDS Institute Partnership · BWHarvard University Press · USMinistry of Health · BW

Funding

The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI Daniel Lingwood · 2004 to 2026
$94.4M
Risk Factors for the Development of Lactic Acidosis and Pancreatitis Among HAART-K23AI073141 · NIAID · VANDERBILT UNIVERSITY · PI WESTER, C. WILLIAM · 2007 to 2011
$643k
NIAID NIH HHS K23 AI073141NIAID NIH HHS K23AI073141NIAID NIH HHS P30 AI060354NIAID NIH HHS P30AI060354
6 · The paper itself

Abstract

backgroundNational initiatives offering non-nucleoside reverse transcriptase inhibitor (NNRTI)-based combination antiretroviral therapy (cART) have expanded in sub-Saharan Africa. The Tshepo study is the first clinical trial evaluating the long-term efficacy and tolerability of efavirenz versus nevirapine-based cART among adults in Botswana.

methodsA 3-year randomized study (n = 650) using a 3 x 2 x 2 factorial design comparing efficacy and tolerability among: (i) zidovudine/lamivudine versus zidovudine/didanosine versus stavudine/lamivudine; (ii) efavirenz versus nevirapine; and (iii) community-based supervision versus standard adherence strategies. This paper focuses on comparison (ii).

resultsThere was no significant difference by assigned NNRTI in time to virological failure with resistance (log-rank P = 0.14), nevirapine versus efavirenz [risk ratio (RR) 1.54, 95% CI 0.86-2.70]. Rates of virological failure with resistance were 9.6% nevirapine-treated (95% CI 6.8-13.5) versus 6.6% efavirenz-treated (95% CI 4.2-10.0) at 3 years. Women receiving nevirapine-based cART trended towards higher virological failure rates when compared with efavirenz-treated women, Holm-corrected (log-rank P = 0.072), nevirapine versus efavirenz (RR 2.22, 95% CI 0.94-5.00). A total of 139 patients had 176 treatment-modifying toxicities, with a shorter time to event in nevirapine-treated versus efavirenz-treated patients (RR 1.85, 1.20-2.86; log-rank P = 0.0002).

conclusionTshepo-treated patients had excellent overall immunological and virological outcomes, and no significant differences were observed by randomized NNRTI comparison. Nevirapine-treated women trended towards higher virological failure with resistance compared with efavirenz-treated women. Nevirapine-treated adults had higher treatment modifying toxicity rates when compared with those receiving efavirenz. Nevirapine-based cART can continue to be offered to women in sub-Saharan Africa if patient education concerning toxicity is emphasized, routine safety monitoring chemistries are performed and the potential risk of efavirenz-related teratogenicity is considered.

Indexed as

HIV-1AdultAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBotswanaDrug Therapy, CombinationFamily Planning ServicesFemaleHIV InfectionsHumansMalePregnancyReverse Transcriptase InhibitorsTreatment OutcomeAnti-HIV AgentsReverse Transcriptase Inhibitors

Identifiers

PMID20023437
PMCPMC3087813
OpenAlexW2111280544

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.