Evaluation of Four Tenofovir-Containing Regimens as First-Line Treatments in Cameroon and Senegal: The Anrs 12115 Dayana Trial

Landman, Roland; Koulla‐Shiro, Sinata; Sow, Papa Salif; Ngolle, Maguy; Diallo, M.; Gueye, Ndèye Fatou Ngom; Moing, Vincent Le; Eymard-Duvernay, Sabrina; Benalychérif, Aı̈da; Charpentier, Charlotte; Peytavin, Gilles; Delaporte, Eric; Girard, Pierre‐Marie

doi:10.3851/imp2675

Cited by 15 publications

(34 citation statements)

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“…A similar study in Uganda among over five thousand treatment-naive patients starting ART observed higher mortality among those initiated on TDF-containing regimen[74]. These findings require more elaborate research because both randomized and observational studies have reported sustained viral suppression and low prevalence of nephrotoxity with use of TDF [75–77]. However, we found no association between LTFU and TDF use.…”

Section: Discussioncontrasting

confidence: 56%

Outcomes of Nigeria's HIV/AIDS Treatment Program for Patients Initiated on Antiretroviral Treatment between 2004-2012

et al. 2016

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BackgroundThe Nigerian Antiretroviral therapy (ART) program started in 2004 and now ranks among the largest in Africa. However, nationally representative data on outcomes have not been reported.MethodsWe evaluated retrospective cohort data from a nationally representative sample of adults aged ≥15 years who initiated ART during 2004 to 2012. Data were abstracted from 3,496 patient records at 35 sites selected using probability-proportional-to-size (PPS) sampling. Analyses were weighted and controlled for the complex survey design. The main outcome measures were mortality, loss to follow-up (LTFU), and retention (the proportion alive and on ART). Potential predictors of attrition were assessed using competing risk regression models.ResultsAt ART initiation, 66.4 percent (%) were females, median age was 33 years, median weight 56 kg, median CD4 count 161 cells/mm3, and 47.1% had stage III/IV disease. The percentage of patients retained at 12, 24, 36 and 48 months was 81.2%, 74.4%, 67.2%, and 61.7%, respectively. Over 10,088 person-years of ART, mortality, LTFU, and overall attrition (mortality, LTFU, and treatment stop) rates were 1.1 (95% confidence interval (CI): 0.7–1.8), 12.3 (95%CI: 8.9–17.0), and 13.9 (95% CI: 10.4–18.5) per 100 person-years (py) respectively. Highest attrition rates of 55.4/100py were witnessed in the first 3 months on ART. Predictors of LTFU included: lower-than-secondary level education (reference: Tertiary), care in North-East and South-South regions (reference: North-Central), presence of moderate/severe anemia, symptomatic functional status, and baseline weight <45kg. Predictor of mortality was WHO stage higher than stage I. Male sex, severe anemia, and care in a small clinic were associated with both mortality and LTFU.ConclusionModerate/Advanced HIV disease was predictive of attrition; earlier ART initiation could improve program outcomes. Retention interventions targeting men and those with lower levels of education are needed. Further research to understand geographic and clinic size variations with outcome is warranted.

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Section: Discussioncontrasting

confidence: 56%

Outcomes of Nigeria's HIV/AIDS Treatment Program for Patients Initiated on Antiretroviral Treatment between 2004-2012

et al. 2016

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“…We included seven RCTs in Mbuagbaw 2010, the previous version of this review (Ayala Gaytán 2004; Manosuthi 2009a; Núñez 2002; Sow 2006; Swaminathan 2011; van den Berg-Wolf 2008; van Leth 2004). In this review update five articles that reported on five trials met the inclusion criteria (Bonnet 2013a; Landman 2014; Mateelli 2013; Sinha 2013; Wester 2010). The findings reported here are from published papers.…”

Section: Resultsmentioning

confidence: 99%

“…Five trials were conducted in Africa: one in Botswana (Wester 2010), one in Mozambique (Bonnet 2013a), one in Burkina Faso (Mateelli 2013), one in Senegal (Sow 2006), and one in both Senegal and Cameroon (Landman 2014). There were two trials from India (Sinha 2013; Swaminathan 2011) and one trial each: from Mexico (Bonnet 2013a), Spain (Núñez 2002), Thailand (Manosuthi 2009a), and the USA (van den Berg-Wolf 2008).…”

Section: Resultsmentioning

confidence: 99%

“… 1 Three trials used a cut-off point of 400 copies/mL (Ayala Gaytán 2004; Swaminathan 2011; Sinha 2013), but we did not downgrade for this. 2 Nine trials were open-label (Ayala Gaytán 2004; Bonnet 2013a; Landman 2014; Manosuthi 2009a; Mateelli 2013; Núñez 2002; Sinha 2013; Swaminathan 2011; van Leth 2004), but we did not downgrade for this. 3 Two trials were industry-funded (Landman 2014; van Leth 2004), but we did not downgrade for this. 4 Seven trials were open-label but we did not downgrade for this (Ayala Gaytán 2004; Bonnet 2013a; Landman 2014; Manosuthi 2009a; Sinha 2013; Swaminathan 2011; van Leth 2004). …”

Section: Summary Of Findings For the Main Comparisonmentioning

confidence: 99%

“… 2 Nine trials were open-label (Ayala Gaytán 2004; Bonnet 2013a; Landman 2014; Manosuthi 2009a; Mateelli 2013; Núñez 2002; Sinha 2013; Swaminathan 2011; van Leth 2004), but we did not downgrade for this.…”

Section: Summary Of Findings For the Main Comparisonmentioning

confidence: 99%

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Efavirenz or nevirapine in three-drug combination therapy with two nucleoside or nucleotide-reverse transcriptase inhibitors for initial treatment of HIV infection in antiretroviral-naïve individuals

Mbuagbaw

Mursleen

Irlam

et al. 2016

Cochrane Database of Systematic Reviews

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BackgroundThe advent of highly active antiretroviral therapy (ART) has reduced the morbidity and mortality due to HIV infection. The World Health Organization (WHO) ART guidelines focus on three classes of antiretroviral drugs, namely nucleoside or nucleotide reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors. Two of the most common medications given as first-line treatment are the NNRTIs, efavirenz (EFV) and nevirapine (NVP). It is unclear which NNRTI is more efficacious for initial therapy. This systematic review was first published in 2010.ObjectivesTo determine which non-nucleoside reverse transcriptase inhibitor, either EFV or NVP, is more effective in suppressing viral load when given in combination with two nucleoside reverse transcriptase inhibitors as part of initial antiretroviral therapy for HIV infection in adults and children.Search methodsWe attempted to identify all relevant studies, regardless of language or publication status, in electronic databases and conference proceedings up to 12 August 2016. We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov to 12 August 2016. We searched LILACS (Latin American and Caribbean Health Sciences Literature) and the Web of Science from 1996 to 12 August 2016. We checked the National Library of Medicine (NLM) Gateway from 1996 to 2009, as it was no longer available after 2009.Selection criteriaWe included all randomized controlled trials (RCTs) that compared EFV to NVP in people with HIV without prior exposure to ART, irrespective of the dosage or NRTI's given in combination.The primary outcome of interest was virological success. Other primary outcomes included mortality, clinical progression to AIDS, severe adverse events, and discontinuation of therapy for any reason. Secondary outcomes were change in CD4 count, treatment failure, development of ART drug resistance, and prevention of sexual transmission of HIV.Data collection and analysisTwo review authors assessed each reference for inclusion using exclusion criteria that we had established a priori. Two review authors independently extracted data from each included trial using a standardized data extraction form. We analysed data on an intention-to-treat basis. We performed subgroup analyses for concurrent treatment for tuberculosis and dosage of NVP. We followed standard Cochrane methodological procedures.Main resultsTwelve RCTs, which included 3278 participants, met our inclusion criteria. None of these trials included children. The length of follow-up time, study settings, and NRTI combination drugs varied greatly. In five included trials, participants were receiving concurrent treatment for tuberculosis.There was little or no difference between EFV and NVP in virological success (RR 1.04, 95% CI 0.99 to 1.09; 10 trials, 2438 participants; high quality evidence), probably little or no...

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A model-based comparative meta-analysis of the efficacy of dolutegravir-based and efavirenz-based regimens in HIV-infected patients

Ota

Ishii

Tsuda

et al. 2019

Journal of Infection and Chemotherapy

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Evaluation of Four Tenofovir-Containing Regimens as First-Line Treatments in Cameroon and Senegal: The Anrs 12115 Dayana Trial

Abstract: Three efficient and safe tenofovir-based triple regimens were identified; the two-drug regimen (tenofovir/lopinavir/ritonavir) did not achieve the protocol-defined virological threshold of efficacy.

Cited by 15 publications

References 24 publications

Outcomes of Nigeria's HIV/AIDS Treatment Program for Patients Initiated on Antiretroviral Treatment between 2004-2012

Outcomes of Nigeria's HIV/AIDS Treatment Program for Patients Initiated on Antiretroviral Treatment between 2004-2012

Efavirenz or nevirapine in three-drug combination therapy with two nucleoside or nucleotide-reverse transcriptase inhibitors for initial treatment of HIV infection in antiretroviral-naïve individuals

A model-based comparative meta-analysis of the efficacy of dolutegravir-based and efavirenz-based regimens in HIV-infected patients

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