Zahra or Zoe, Arjun or Andrew? Bicultural baby names reflect identity and pragmatic concerns.

OBJECTIVES: Ethnic first names are a visible product of diversity in the West, yet little is known about the psychological factors that influence naming preferences and choices among bicultural individuals. METHOD: Participants in Studies 1a (South Asian Canadians; N = 326) and 1b (Iranian Canadians; N = 126) were prospective parents who completed an online survey with measures of naming (consequences of ethnic naming, naming preferences) and psychological factors related to naming: heritage and mainstream acculturation, ethno-cultural continuity. Study 2 participants (N = 211) were parents of an Indian background living in three English speaking countries (Canada, United States, UK). They completed an online survey with measures of naming (consequences of ethnic naming, names as markers of cultural identity, actual naming choices) and psychological factors: heritage and mainstream cultural identifications, ethno-cultural continuity. RESULTS: Across all 3 studies we observed a strong preference for ethnic over mainstream names. In Studies 1a and 1b heritage acculturation and motivation for ethno-cultural continuity predicted stronger preference for ethnic names. In contrast, a preference for mainstream names was predicted by mainstream acculturation and expectations of negative consequences of ethnic names. In Study 2 choice of an ethnic name was positively related to beliefs about names as markers of ethnic identity, and negatively related to expectations of negative consequences of ethnic names. CONCLUSIONS: Baby naming among ethnic minorities is a complex cultural decision, reflecting both identity and pragmatic concerns. Implications for studies of acculturation and identity, and future research directions are discussed. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop.

Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA's 2011 Strategic Plan for Regulatory Science [Appendix]. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path) [www.c-path.org], FDA, and International Society of Pharmacometrics [www.go-isop.org] co-sponsored a workshop in Washington, D.C. on September 26, 2013, to examine integrated approaches to developing and applying model- MIMPD. The workshop brought together an international group of scientists from industry, academia, FDA, and the European Medicines Agency to discuss MIMPD strategies and their applications. A commentary on the proceedings of that workshop is presented here.

How debunking biases in research and development decisions could lead to more equitable healthcare?

Decades of research have demonstrated that a variety of cognitive biases can affect our judgment and ability to make rational decisions in personal and professional environments. The lengthy, risky, and costly nature of pharmaceutical research and development (R&D) makes it vulnerable to biased decision-making. Moreover, cognitive biases can play a role in regulatory and clinical decision-making, the latter impacting diagnostic and treatment decisions in the therapeutic use of medicines. These inherent and/or institutionalized biases (e.g., in assumptions, data, or decision-making practices) could conceivably contribute to health inequities. In this mini-review, we provide a broad perspective on how cognitive biases can affect pharmaceutical R&D, regulatory evaluation, and therapeutic decision-making. Example approaches to mitigate the effect of common biases in the development, approval, and use of new therapeutics, such as quantitative decision criteria, multidisciplinary reviews, regulatory and treatment guidelines, and evidence-based clinical decision support systems are illustrated. Mitigating the impact of cognitive biases could increase pharma R&D efficiency, change the perspective and prioritization of unmet medical needs, increase representativeness and quality of evidence generated through clinical trials and real-world research, leading to higher quality insights and more effective medication use, and as such could eventually contribute to more equitable healthcare.

Negligible effect of tenofovir on atazanavir trough concentrations and genotypic inhibitory quotients in the presence and absence of ritonavir.

BACKGROUND: It is recommended to boost atazanavir with ritonavir (ATV/r) when it is combined with tenofovir disoproxil fumarate (TDF) because of drug interactions. For tolerability, unboosted atazanavir (ATV) is sometimes coadministered with TDF. The objective of this study was to evaluate the impact of this interaction on the proportion of patients achieving target ATV C troughs and genotypic inhibitory quotients (GIQ). MATERIALS AND METHODS: A therapeutic drug monitoring database was screened to evaluate ATV concentrations. Differences in C trough and GIQ values among 4 antiretroviral drug combinations were evaluated. RESULTS: Three hundred eight C troughs, 91 GIQs, and 92 viral loads were evaluated for 238, 68, and 69 patients, respectively. Patients receiving ATV/r and TDF compared with ATV and TDF were more likely to have a therapeutic C trough (odds ratio, 2.27; 95% confidence interval: 1.46-3.52; P < 0.001). Among patients on unboosted ATV, the odds of having a therapeutic ATV C trough did not differ between groups with TDF versus without TDF. Although ritonavir increased the GIQ in patients receiving TDF (odds ratio, 3.38; 95% confidence interval: 1.30-8.81; P = 0.013), a similar proportion of patients on TDF and either ATV/r or ATV achieved a therapeutic GIQ. CONCLUSIONS: In patients receiving TDF, ritonavir increased the ATV C trough and GIQ and patients on ATV/r were more likely to have therapeutic C troughs. However, among subjects without ritonavir boosting, TDF compared with other nucleosides did not influence the odds of achieving a therapeutic ATV C trough. These data suggest that ritonavir boosting of ATV is prudent, particularly in patients with resistance mutations.

HIV-1 tropism testing and clinical management of CCR5 antagonists: Quebec review and recommendations.

HIV-1 tropism assays play a crucial role in determining the response to CCR5 receptor antagonists. Initially, phenotypic tests were used, but limited access to these tests prompted the development of alternative strategies. Recently, genotyping tropism has been validated using a Canadian technology in clinical trials investigating the use of maraviroc in both experienced and treatment-naive patients. The present guidelines review the evidence supporting the use of genotypic assays and provide recommendations regarding tropism testing in daily clinical management.

Les tests de détermination du tropisme du VIH-1 jouent un rôle capital dans la détermination de la réponse aux antagonistes des récepteurs du CCR5. Au début, on utilisait des tests phénotypiques, mais leur accès limité a suscité l'élaboration d'autres stratégies. Récemment, le génotypage du tropisme a été validé à l'aide d'une technologie canadienne, dans le cadre d'essais cliniques faisant appel au maraviroc tant chez des patients déjà en traitement que chez des patients naïfs au traitement. Les présentes lignes directrices passent en revue les données probantes en appui à l'utilisation de tests génotypiques et contiennent des recommandations au sujet des tests de détermination du tropisme dans la prise en charge clinique quotidienne.

The effect of ß-carotene supplementation on the pharmacokinetics of nelfinavir and its active metabolite M8 in HIV-1-infected patients.

ß-Carotene supplements are often taken by individuals living with HIV-1. Contradictory results from in vitro studies suggest that ß-carotene may inhibit or induce cytochrome P450 enzymes and transporters. The study objective was to investigate the effect of ß-carotene on the steady-state pharmacokinetics of nelfinavir and its active metabolite M8 in HIV-1 infected individuals. Twelve hour nelfinavir pharmacokinetic analysis was conducted at baseline and after 28 days of ß-carotene supplementation (25,000 IU twice daily). Nelfinavir and M8 concentrations were measured with validated assays. Non-compartmental methods were used to calculate the pharmacokinetic parameters. Geometric mean ratios comparing day 28 to day 1 area under the plasma concentration-time curve (AUC(0-12 h)), maximum (C(max)) and minimum (C(min)) concentrations of nelfinavir and M8 are presented with 90% confidence intervals. Eleven subjects completed the study and were included in the analysis. There were no significant differences in nelfinavir AUC(0-12 h) and C(min) (-10%, +4%) after ß-carotene supplementation. The M8 C(min) was increased by 31% while the M8 AUC(0-12 h) and C(max) were unchanged. During the 28 day period, mean CD4+ % and CD4+:CD8+ ratio increased significantly (p < 0.01). ß-carotene supplementation increased serum carotene levels but did not cause any clinically significant difference in the nelfinavir and M8 exposure.

Outcomes of chronic hepatitis C therapy in patients treated in community versus academic centres in Canada: final results of APPROACH (a prospective study of peginterferon alfa-2a and ribavirin at academic and community centres in Canada).

BACKGROUND: In patients chronically infected with the hepatitis C virus (HCV), it is not established whether viral outcomes or health-related quality of life (HRQoL) differ between individuals treated at academic or community centres. METHODS: In the present observational study, adults with chronic HCV were treated with peginterferon alfa-2a 180 ìg/week plus ribavirin at 45 Canadian centres (16 academic, 29 community). The primary efficacy end point was sustained virological response (SVR). Other outcome measures included HRQoL (assessed using the 36-item Short-Form Health Survey), heath resource use, and workplace productivity and absences within a 60-day interval. RESULTS: In treatment-naive patients infected with HCV genotype 1, significantly higher SVR rates were achieved in those treated at academic (n=54) compared with community (n=125) centres (52% versus 32% [P=0.01]), although rates of dosage reduction and treatment discontinuation were similar across settings. SVR rates among patients infected with genotype 2/3 were similar between academic (n=59) and community (n=100) centres (64% versus 67% [P=0.73]). Following antiviral therapy, patients with genotype 1 who achieved an SVR (n=67) had significantly higher mean scores on the physical (P=0.005) and mental components of the 36-item Short-Form Health Survey (P=0.043) compared with those without an SVR (n=111). In contrast, HRQoL scores were similar in HCV genotype 2/3 patients with and without an SVR. There were no differences in workplace productivity or absences between patients with and without an SVR. The most frequently used health care resources by all patients were visits and phone calls to hepatitis nurses, and general practice or walk-in clinics. CONCLUSION: Patients infected with HCV genotype 1 achieved higher SVR rates when treated at academic rather than community centres in Canada. The reasons for this difference require additional investigation.

Bias against foreign-born or foreign-trained doctors: experimental evidence.

OBJECTIVES: Bias against foreign-born or -trained medical students and doctors is not well understood, despite its documented impact on recruitment, integration and retention. This research experimentally examines the interaction of location of medical education and nationality in evaluations of doctors' competence and trustworthiness. METHODS: A convenience sample of prospective patients evaluated fictitious candidates for a position as a doctor in community practice at a new local health clinic. All applicants were described as having the same personality profile, legal qualifications to practise, a multi-degree education and relevant work experience. The location of medical education (the candidate's home country or the UK) and national background (Australia or Pakistan) of the applicants were independently experimentally manipulated. RESULTS: Consistent with previous research on skills discounting and bias, foreign-born candidates were evaluated less favourably than native-born candidates, despite their comparable education level, work experience and personality. However, overseas medical education obtained in the First World both boosted evaluations (of competence and trustworthiness) and attenuated bias based on nationality. CONCLUSIONS: The present findings demonstrate the selective discounting of foreign-born doctors' credentials. The data show an interaction of location of medical education and birth nationality in bias against foreign doctors. On an applied level, the data document that the benefits of medical education obtained in the First World can extend beyond its direct outcomes (high-quality training and institutional recognition) to the indirect benefit of the attenuation of patient bias based on nationality.

Bicultural identity conflict in second-generation Asian Canadians.

Researchers have shown that bicultural individuals, including 2nd-generation immigrants, face a potential conflict between 2 cultural identities. The present authors extended this primarily qualitative research on the bicultural experience by adopting the social identity perspective (H. Tajfel & J. C. Turner, 1986). They developed and tested an empirically testable model of the role of cultural construals, in-group prototypicality, and identity in bicultural conflict in 2 studies with 2nd-generation Asian Canadians. In both studies, the authors expected and found that participants' construals of their 2 cultures as different predicted lower levels of simultaneous identification with both cultures. Furthermore, the authors found this relation was mediated by participants' feelings of prototypicality as members of both groups. Although the perception of cultural difference did not predict well-being as consistently and directly as the authors expected, levels of simultaneous identification did show these relations. The authors discuss results in the context of social identity theory (H. Tajfel & J. C. Turner) as a framework for understanding bicultural conflict.

Performance characteristics for some typical QT study designs under the ICH E-14 guidance.

The International Conference on Harmonization (ICH) guidance for clinical evaluation of QT prolongation (E14) affected drug development by advocating that a thorough QT study (TQT) be conducted during development to assess the QT prolongation liability of a compound. The ICH E14 Statistics Group shortly thereafter recommended that a noninferiority intersection-union test (IUT) be used to exclude a clinically worrisome QT prolongation. Recent analyses have indicated that the IUT might be overly conservative with respect to excluding QT prolongation. This report assesses the IUT false positive rate for 4 recently conducted TQT trials using simple simulation experiments. Positive TQT study rates ranged from negligible to nearly 60% depending on study design, sample size, and patient status, despite no drug effect. Addition of clinically nonmeaningful QT prolongations (up to 5 milliseconds) increased the positive study rate to 80% for 1 particular study design. Ultimately, these results reveal significant limitations of the IUT with respect to excluding an effect and study interpretation for certain trial designs.

Know Your Heritage: Exploring the Effects of Fit in Cultural Knowledge on Chinese Canadians' Heritage Identification.

In the present research, we introduce the notion of fit in cultural knowledge (FICK) - which we define as a match between the self and others in representing a cultural tradition. For ethnic minorities, FICK can be manifested in different degrees of matching their personal beliefs about their heritage culture with outgroup as well as ingroup beliefs about their heritage culture. We conducted two studies with the objective of exploring the potentially negative effects of FICK on Chinese Canadians' heritage identification. In both studies, Chinese Canadian university students (N = 102; N = 156) indicated their personal beliefs about what values are normative in Chinese culture. Ingroup beliefs were assessed by beliefs about Chinese values that Chinese Canadians ascribed to their parents (Study 2), whereas outgroup beliefs were assessed by beliefs about Chinese values that were held by Euro-Canadians (Study 1) or that Chinese Canadians ascribed to Euro-Canadians (Study 2). The main findings based on a series of path models are as follows: (1) a stronger FICK generally predicted lower Chinese identification (centrality, ingroup ties, and affect), yet those negative effects were largely manifested in the openness to change versus conservation rather than in the self-transcendence versus self-enhancement value dimension. (2) The negative effects could be explained by Chinese Canadians' experience of bicultural conflict (Study 1) and the frustration of continuity, meaning, and belonging identity motives (Study 2), suggesting that it matters which specific views of Chinese culture are matched in FICK. 3) Individuals who agreed with the perceived outgroup beliefs, and parental beliefs to a lesser extent, were more likely to apply the model minority stereotype to other Chinese Canadians (Study 2). Taken together, those findings demonstrate the challenges FICK presents to heritage identity maintenance among Chinese Canadian young adults. Implications for enculturation and cultural fit are discussed.

Therapeutic drug monitoring in treatment-experienced HIV-infected patients receiving darunavir-based salvage regimens: A case series.

Therapeutic drug monitoring (TDM) constitutes a compelling approach for the optimization of antiretroviral therapy in treatment-experienced HIV-1 patients. While various inhibitory indices have been proposed to predict virologic outcome, there is a lack of consensus on the clinical value of TDM. Here, we report the comparative results of TDM in 14 HIV-1-infected patients who had previously received at least two different PI-based regimens and who initiated darunavir (DRV)-based salvage therapy. Pharmacokinetic/pharmacodynamics (PK/PD) parameters were calculated for each subject. Seventy-nine percent of subjects had a viral load <50 copies/mL at 48 weeks. The only subject with two consecutive viral loads >50 copies/mL at the end of the study period was the patient with the lowest instantaneous inhibitory potential (IIP). The sample size was insufficient to show an association between any of the PK/PD parameters and virologic response. Based on our observations, we suggest that the utility of IIP for antiretroviral combinations for the prediction of virologic outcome in HIV-1 drug-experienced patients should be studied further.

External quality assessment of HLA-B*5701 reporting: an international multicentre survey.

OBJECTIVES: HLA-B*5701 strongly predicts abacavir hypersensitivity (HSR), but implementation of effective routine screening into clinical practice requires testing be practical and accurate. We tested the proficiency of HLA-B*5701 typing among laboratories using sequence-specific primer PCR. DESIGN AND METHODS: DNA panels (1 and 2) were distributed to seven laboratories (A to G) for blinded typing of the HLA-B*5701 allele. Panel 1 (n = 10 samples; n = 7 laboratories) included 3 positives and other closely related B17 subtypes (B*5702, B*5703, B*5704 and B*5801). Panel 2 (n = 96 samples; n = 4 laboratories) included 36 positives among a broad spectrum of other B alleles. Two laboratories (A and B) also submitted 96 routine samples, typed by the same methodology, to the reference centre for additional analysis by sequence-based typing. RESULTS: All laboratories correctly typed panel 1 for HLA-B*5701 carriage. Laboratories A, B and C identified HLA-B*5701 alleles in panel 2 with 100% sensitivity and 100% specificity. Laboratory D reported one false negative, reportedly due to a sampling error. The results obtained for routine samples typed by laboratories A and B and those generated by the reference laboratory using sequencing were fully concordant. CONCLUSIONS: Detection of HLA-B*5701 alleles among laboratories was 100% specific and 99.4% sensitive, indicating that participating HIV testing laboratories were currently offering effective primary screening to identify individuals at high risk of abacavir HSR. Accurate reporting of HLA-B*5701 status is critical for the safe administration of this drug and participation in quality assurance programmes by all sites who report HLA-B*5701 status should be promoted.

Lopinavir-ritonavir versus nelfinavir for the initial treatment of HIV infection.

BACKGROUND: Lopinavir is a newly developed inhibitor of human immunodeficiency virus (HIV) protease that, when formulated with ritonavir, yields mean trough plasma lopinavir concentrations that are at least 75 times as high as that needed to inhibit replication of wild-type HIV by 50 percent. METHODS: We conducted a double-blind trial in which 653 HIV-infected adults who had not received antiretroviral therapy for more than 14 days were randomly assigned to receive either lopinavir-ritonavir (400 mg of lopinavir plus 100 mg of ritonavir twice daily) with nelfinavir placebo or nelfinavir (750 mg three times daily) with lopinavir-ritonavir placebo. All patients also received open-label stavudine and lamivudine. The primary efficacy end points were the presence of fewer than 400 HIV RNA copies per milliliter of plasma at week 24 and the time to the loss of virologic response through week 48. RESULTS: At week 48, greater proportions of patients treated with lopinavir-ritonavir than of patients treated with nelfinavir had fewer than 400 copies of HIV RNA per milliliter (75 percent vs. 63 percent, P<0.001) and fewer than 50 copies per milliliter (67 percent vs. 52 percent, P<0.001). The time to the loss of virologic response was greater in the lopinavir-ritonavir group than in the nelfinavir group (hazard ratio, 2.0; 95 percent confidence interval, 1.5 to 2.7; P<0.001). The estimated proportion of patients with a persistent virologic response through week 48 was 84 percent for patients receiving lopinavir-ritonavir and 66 percent for those receiving nelfinavir. Both regimens were well tolerated, with the rate of discontinuation related to the study drugs at 3.4 percent among patients receiving lopinavir-ritonavir and 3.7 percent among patients receiving nelfinavir. Among patients with more than 400 copies of HIV RNA per milliliter at some point from week 24 through week 48, resistance mutations in HIV protease were demonstrated in viral isolates from 25 of 76 nelfinavir-treated patients (33 percent) and none of 37 patients treated with lopinavir-ritonavir (P<0.001). CONCLUSIONS: For the initial treatment of HIV-infected adults, a combination regimen that includes lopinavir-ritonavir is well tolerated and has antiviral activity superior to that of a nelfinavir-containing regimen.

Efficacy and safety of three doses of tipranavir boosted with ritonavir in treatment-experienced HIV type-1 infected patients.

The efficacy, safety, and pharmacokinetics of three doses of tipranavir/ritonavir (TPV/r) in highly treatment-experienced human immunodeficiency virus (HIV)-1-infected patients with protease inhibitor (PI)-resistant isolates were evaluated. A 24-week multicenter, double-blind, randomized, dose-finding trial was conducted. All patients were three-drug class experienced and had taken at least two PI-based regimens. All had at least one primary PI mutation and had plasma HIV-RNA > 1000 copies/ml. Patients remained on their background non-PI antiretroviral medications for the first 14 days. After this 14-day period of functional TPV/r monotherapy, the background antiretroviral medications were optimized based on treatment history and the screening genotype. A total of 216 patients were randomized. All groups [TPV/r 500 mg/100 mg (n = 73), 500 mg/200 mg (n = 72), and 750 mg/200 mg (n = 71) twice daily] achieved an approximate 1 log10 reduction in the median HIV-RNA at week 2. A significant reduction was sustained through 24 weeks in the TPV/r 500 mg/200 mg and 750 mg/200 mg groups. The 500 mg/200 mg dose achieved optimal median TPV trough concentrations and lower interpatient variability. The most frequently reported adverse events (AEs) were diarrhea, nausea, vomiting, fatigue, and headache. The TPV/r 750 mg/200 mg group had the highest rate of grade 3 or 4 laboratory abnormalities and study discontinuations due to AEs. All doses of TPV/r tested in this study were associated with HIV-1 viral load reductions through 24 weeks. The 500 mg/200 mg dose achieved the best efficacy, safety, and pharmacokinetic profile in this highly treatment-experienced population and was selected for the pivotal phase 3 studies.

Barriers preventing liver transplantation in Canadians with HIV-infection--perceptions of HIV specialists.

Liver transplantation is a life-saving procedure with demonstrated utility. There are accumulating data indicating that this procedure is helpful in HIV-infected patients as well. Liver transplantation is currently largely unavailable to those living with HIV in Canada. Understanding the obstacles to this procedure is the first step to increasing access. Between August 2005 and November 2005, HIV physicians, one from each Canadian HIV Trials Network site, were asked to complete a quantitative questionnaire on adult liver transplant access and need. Forty-six per cent (16 of 35) of sites responded. A median 20% of the nearly 12,700 HIV patients followed at these sites had concurrent liver disease (20% caused by hepatitis C virus, 5% caused by hepatitis B virus and 5% were alcohol-related). On average, two patients per site were thought to be appropriate candidates for liver transplant evaluation. Eighty per cent of respondents anticipated increased need for liver transplantation over the next five years. Organ supply was universally identified as the chief obstacle to transplantation in patients with HIV. Other key issues included risk of hepatitis C virus reinfection and transplant surgical team willingness. Based on these data, it is believed that these issues should be the focus of efforts designed to increase access to transplantation in Canadians with end-stage liver disease and concurrent HIV.

Management and treatment of hepatitis C virus in patients with HIV and hepatitis C virus coinfection: A practical guide for health care professionals.

Concomitant HIV and hepatitis C virus (HCV) is a common yet complex coinfection. The present document is a practical guide for treating HCV infection in people coinfected with HIV. Effective antiretroviral therapies have prolonged survival rates for HIV-infected people over the past decade, which have made latent complications of HCV major causes of morbidity and mortality in these patients. Advances in the treatment of HCV (eg, combined pegylated interferon and ribavirin) offer the possibility of eradicating HCV infection in coinfected persons. The treatment of HCV must be considered in all cases. Intensive management of the adverse effects of HCV treatment is one of the factors for the success of these therapies. HCV eradication is predicted to decrease the mortality associated with coinfection and reduce the toxicity of HIV treatment.

Self-consistency in Bicultural Persons: Dialectical Self-beliefs Mediate the Relation between Identity Integration and Self-consistency.

Prior research differentiates dialectical (e.g., East Asian) from non-dialectical cultures (e.g., North American and Latino) and attributes cultural differences in self-concept consistency to naïve dialecticism. In this research, we explored the effects of managing two cultural identities on consistency within the bicultural self-concept via the role of dialectical beliefs. Because the challenge of integrating more than one culture within the self is common to biculturals of various heritage backgrounds, the effects of bicultural identity integration should not depend on whether the heritage culture is dialectical or not. In four studies across diverse groups of bicultural Canadians, we showed that having an integrated bicultural identity was associated with being more consistent across roles (Studies 1-3) and making less ambiguous self-evaluations (Study 4). Furthermore, dialectical self-beliefs mediated the effect of bicultural identity integration on self-consistency (Studies 2-4). Finally, Latino biculturals reported being more consistent across roles than did East Asian biculturals (Study 2), revealing the ethnic heritage difference between the two groups. We conclude that both the content of heritage culture and the process of integrating cultural identities influence the extent of self-consistency among biculturals. Thus, consistency within the bicultural self-concept can be understood, in part, to be a unique psychological product of bicultural experience.

Canadian Consensus Recommendations for the Optimal Use of Enfuvirtide in HIV/AIDS Patients.

BACKGROUND AND OBJECTIVES: An eight-member group consisting of Canadian infectious disease and immunology specialists and a family physician with significant experience in HIV management was convened to update existing recommendations, specifically intended for use by Canadian HIV-treating physicians, on the appropriate use of enfuvirtide in HIV/AIDS patients with resistance to other antiretroviral drugs. METHODS: Evidence from the literature and expert opinions of the group members formed the basis of the guidelines. Comments on the draft guidelines were obtained from other physicians across Canada with HIV expertise. The final guidelines represent the group's consensus agreement. RESULTS AND CONCLUSIONS: The recommendations were developed to guide physicians in optimal practices in patient selection for enfuvirtide treatment and subsequent patient management. The issues considered include positive predictors of response to enfuvirtide, stage of disease, optimization of the background regimen, early indicators of enfuvirtide response, and patient education and support.