Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine in HIV-1-infected adults in Cameroon: open-label multicentre trial

Laurent, Christian; Kouanfack, Charles; Koulla‐Shiro, Sinata; Nkoué, Nathalie; Bourgeois, Anke; Calmy, Alexandra; Lactuock, Bernadette; Nzeusseu, Viviane; Mougnutou, Rose; Peytavin, Gilles; Liégeois, Florian; Nerrienet, Eric; Tardy, Michèle; Peeters, Martine; Andrieux-Meyer, Isabelle; Zekeng, Léopold; Kazatchkine, Michel D.; Mpoudi‐Ngolé, Eitel; Delaporte, Eric

doi:10.1016/s0140-6736(04)16586-0

Cited by 257 publications

(178 citation statements)

References 22 publications

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“…These high levels of adherence confirm findings in other resource-limited settings (Byakika-Tusiime et al 2005;Fong et al 2003;Landman et al 2003;Laniece et al 2003;Laurent et al 2004;Laurent et al 2005a, b;Nachega et al 2004;Orrell et al 2003;Oyugi et al 2004;Remien et al 2003;Weidle et al 2002;Weiser et al 2003). Our findings contrast with those of Merenstein et al (2008), who found an inverse relationship between adherence and the number of children in the family.…”

Section: Discussionsupporting

confidence: 82%

“…While most studies have shown high levels of adherence to ART in resource-constrained settings Bisson et al 2008;Byakika-Tusiime et al 2005;Diabate et al 2007;Etard et al 2007;Fong et al 2003;Landman et al 2003;Laniece et al 2003;Laurent et al 2004;Laurent et al 2005a, b;Mills et al 2006b;Nachega et al 2004;Orrell et al 2003;Oyugi et al 2004;Remien et al 2003;San Lio et al 2008;Tadios and Davey 2006;Weidle et al 2002;Weidle et al 2006;Weiser et al 2003) there has been little discussion about how HIV? women balance the demands of adherence to HIV ART, childcare, and antiretroviral adherence among their children who are HIV-infected.…”

Section: Introductionmentioning

confidence: 99%

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Longitudinal Antiretroviral Adherence in HIV+ Ugandan Parents and Their Children Initiating HAART in the MTCT-Plus Family Treatment Model: Role of Depression in Declining Adherence Over Time

et al. 2009

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We conducted a study to assess the effect of family-based treatment on adherence amongst HIV-infected parents and their HIV-infected children attending the Mother-To-Child-Transmission Plus program in Kampala, Uganda. Adherence was assessed using home-based pill counts and self-report. Mean adherence was over 94%. Depression was associated with incomplete adherence on multivariable analysis. Adherence declined over time. Qualitative interviews revealed lack of transportation money, stigma, clinical response to therapy, drug packaging, and cost of therapy may impact adherence. Our results indicate that providing ART to all eligible HIV-infected members in a household is associated with excellent adherence in both parents and children. Adherence to ART among new parents declines over time, even when patients receive treatment at no cost. Depression should be addressed as a potential barrier to adherence. Further study is necessary to assess the long-term impact of this family treatment model on adherence to ART in resource-limited settings.

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Section: Discussionsupporting

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Longitudinal Antiretroviral Adherence in HIV+ Ugandan Parents and Their Children Initiating HAART in the MTCT-Plus Family Treatment Model: Role of Depression in Declining Adherence Over Time

et al. 2009

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“…Forty nine per cent of patients developed at least one ADR in this cohort; previous studies have reported antiretroviral toxicity in 11 -76% of their cohorts, but comparison between studies is difficult as a result of differences in reporting of ADRs; studies may report overall ADRs, severe ADRs only, treatment-limiting ADRs, or laboratory diagnosed ADRs only (11)(12)(13). Nevertheless, this prevalence of ADRs compares well with other studies in resource-limited settings.…”

Section: Discussionsupporting

confidence: 56%

Prevalence of adverse drug reactions in adult patients on anti-retrovirals at Kenyatta National Hospital, Comprehensive Care Centre

Mwangangi¹,

Juma²,

Scott³

et al. 2010

E Af Med Jrnl

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“…2 A few studies have reported the effectiveness and safety of generic FDCs for treatment of HIV-1-infected adults. [2][3][4][5] It has been suggested that a variety of demographic factors such as age, body size, and weight can influence antiretroviral drug concentrations. 6 Sex-based differences in the pharmacokinetics of nevirapine have also been observed.…”

mentioning

confidence: 99%

Steady-State Pharmacokinetics of Nevirapine in HIV-1 Infected Adults in India

Ramachandran

Hemanthkumar

Rajasekaran

et al. 2007

Journal of the International Association of Physicians in AIDS

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Background and Objectives:A variety of demographic factors, sex, and degree of immunosuppression can influence antiretroviral drug concentrations. The authors studied the influence of immune status, sex, and body mass index (BMI) on the steady-state pharmacokinetics of nevirapine delivered as a fixed-dose combination in HIV-1-infected patients in India. Methods: Twenty-six HIV-1-infected adult patients undergoing treatment with nevirapine-based highly active antiretroviral therapy regimens participated in the study. Pharmacokinetic variables were compared between patients divided based on CD4 cell counts, sex, and BMI. Results: Patients with higher BMI had lower peak and trough concentration and exposure of nevirapine than those with lower BMI; none of the differences in the pharmacokinetic variables of nevirapine between the various patient groups was statistically significant. Conclusions: Patients' immune status, sex, or BMI had no impact on the pharmacokinetics of nevirapine. Plasma nevirapine concentrations were maintained within the therapeutic range of the drug in the majority of the patients.Keywords: pharmacokinetics; nevirapine; India; immune status; sex; BMI Access to antiretroviral drugs for HIV-1-infected patients in developing countries is a global public health priority. The World Health Organization currently recommends first-line therapy with 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 non-NRTI (NNRTI)⎯a combination with good efficacy, tolerability, simplicity, and low cost. 1 Generic fixed-dose combinations (FDCs) of such regimens are widely regarded as crucial for scaling up AIDS treatment in developing countries. Two triple-drug combinations consisting of nevirapine and lamivudine with either stavudine or zidovudine as the third agent are available as FDCs in the developing world. A vast majority of HIV-infected patients in India receive nevirapine-based highly active antiretroviral therapy (HAART), the common co-drugs being lamivudine and stavudine. 2 A few studies have reported the effectiveness and safety of generic FDCs for treatment of HIV-1-infected adults. [2][3][4][5] It has been suggested that a variety of demographic factors such as age, body size, and weight can influence antiretroviral drug concentrations. 6 Sex-based differences in the pharmacokinetics of nevirapine have also been observed. 7 Keating et al reported that malabsorption correlates significantly with the degree of immunosuppression. 8 We undertook a study to obtain information on the pharmacokinetics of nevirapine in HIV-infected patients on treatment with FDCs in India, as well as the influence of immunological status, sex, and body mass index (BMI) on the pharmacokinetics of these drugs, as very limited information is available on this aspect. Methods PatientsThe study participants were composed of HIV-infected patients of ethnic Indian origin who were participating in a controlled clinical trial and were being followed

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Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine in HIV-1-infected adults in Cameroon: open-label multicentre trial

Cited by 257 publications

References 22 publications

Longitudinal Antiretroviral Adherence in HIV+ Ugandan Parents and Their Children Initiating HAART in the MTCT-Plus Family Treatment Model: Role of Depression in Declining Adherence Over Time

Longitudinal Antiretroviral Adherence in HIV+ Ugandan Parents and Their Children Initiating HAART in the MTCT-Plus Family Treatment Model: Role of Depression in Declining Adherence Over Time

Prevalence of adverse drug reactions in adult patients on anti-retrovirals at Kenyatta National Hospital, Comprehensive Care Centre

Steady-State Pharmacokinetics of Nevirapine in HIV-1 Infected Adults in India

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