DSpace Repository :: Browsing by Author "Montaner, Julio"

Browsing by Author "Montaner, Julio"

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A Randomized, Open-Label Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor-Sparing Regimen in Antiretroviral-Naive HIV-Infected Patients
(2009-03) Harris, Marianne; Côté, Hélène; Ochoa, Claudia; Allavena, Clotilde; Negredo, Eugenia; Thorne, Anona; Cahn, Pedro; Raffi, Francois; Clotet, Bonaventura; Singer, Joel; Montaner, Julio; The CTN 177 Study Team
Antiretroviral Treatment of Adult HIV Infection 2010 Recommendations of the International AIDS Society-USA Panel
(2010) Thompson, Melanie A.; Aberg, Judith A.; Cahn, Pedro; Montaner, Julio; Rizzardini, Giuliano; Telenti, Amalio; Gatell, Jose; Günthard, Huldrych F.; Hammer, Scott M.; Hirsch, Martin S.; Jacobsen, Donna M.; Reiss, Peter; Richman, Douglas D.; Volberding, Paul A.; Yeni, Patrick; Schooley, Robert T.; International AIDS Society-USA
Context Recent data regarding the consequences of untreated human immunodeficiency virus (HIV) infection and the expansion of treatment choices for antiretroviralnaive and antiretroviral-experienced patients warrant an update of the International AIDS Society–USA guidelines for the use of antiretroviral therapy in adults with HIV infection. Objectives To provide updated recommendations for management of HIVinfected adults, using antiretroviral drugs and laboratory monitoring tools available in the international, developed-world setting. This report provides guidelines for when to initiate antiretroviral therapy, selection of appropriate initial regimens, patient monitoring, when to change therapy, and what regimens to use when changing. Data Sources and Study Selection A panel with expertise in HIV research and clinical care reviewed relevant data published or presented at selected scientific conferences since the last panel report through April 2010. Data were identified through a PubMed search, review of scientific conference abstracts, and requests to antiretroviral drug manufacturers for updated clinical trials and adverse event data. Data Extraction and Synthesis New evidence was reviewed by the panel. Recommendations were drafted by section writing committees and reviewed and edited by the entire panel. The quality and strength of the evidence were rated and recommendations were made by full panel consensus. Conclusions Patient readiness for treatment should be confirmed before initiation of antiretroviral treatment. Therapy is recommended for asymptomatic patients with a CD4 cell count 500/µL, for all symptomatic patients, and those with specific conditions and comorbidities. Therapy should be considered for asymptomatic patients with CD4 cell count 500/µL. Components of the initial and subsequent regimens must be individualized, particularly in the context of concurrent conditions. Patients receiving antiretroviral treatment should be monitored regularly; treatment failure should be detected and managed early, with the goal of therapy, even in heavily pretreated patients, being HIV-1 RNA suppression below commercially available assay quantification limits.
Antiretroviral Treatment of Adult HIV Infection: 2008 Recommendations of the International AIDS Society–USA Panel
(2008) Hammer, Scott M.; Eron, Joseph J. Jr.; Reiss, Peter; Schooley, Robert T.; Thompson, Melanie A.; Walmsley, Sharon L.; Cahn, Pedro; Fischl, Margaret A.; Gatell, Jose; Hirsch, Martin S.; Jacobsen, Donna M.; Montaner, Julio; Richman, Douglas D.; Yeni, Patrick; Volberding, Paul A.; International AIDS Society-USA
Context: The availability of new antiretroviral drugs and formulations, including drugs in new classes, and recent data on treatment choices for antiretroviral-naive and -experienced patients warrant an update of the International AIDS Society-USA guidelines for the use of antiretroviral therapy in adult human immunodeficiency virus (HIV) infection. Objectives: To summarize new data in the field and to provide current recommendations for the antiretroviral management and laboratory monitoring of HIV infection. This report provides guidelines in key areas of antiretroviral management: when to initiate therapy, choice of initial regimens, patient monitoring, when to change therapy, and how best to approach treatment options, including optimal use of recently approved drugs (maraviroc, raltegravir, and etravirine) in treatment-experienced patients. Data sources and study selection: A 14-member panel with expertise in HIV research and clinical care was appointed. Data published or presented at selected scientific conferences since the last panel report (August 2006) through June 2008 were identified. Data extraction and synthesis: Data that changed the previous guidelines were reviewed by the panel (according to section). Guidelines were drafted by section writing committees and were then reviewed and edited by the entire panel. Recommendations were made by panel consensus. Conclusions: New data and considerations support initiating therapy before CD4 cell count declines to less than 350/microL. In patients with 350 CD4 cells/microL or more, the decision to begin therapy should be individualized based on the presence of comorbidities, risk factors for progression to AIDS and non-AIDS diseases, and patient readiness for treatment. In addition to the prior recommendation that a high plasma viral load (eg, >100,000 copies/mL) and rapidly declining CD4 cell count (>100/microL per year) should prompt treatment initiation, active hepatitis B or C virus coinfection, cardiovascular disease risk, and HIV-associated nephropathy increasingly prompt earlier therapy. The initial regimen must be individualized, particularly in the presence of comorbid conditions, but usually will include efavirenz or a ritonavir-boosted protease inhibitor plus 2 nucleoside reverse transcriptase inhibitors (tenofovir/emtricitabine or abacavir/lamivudine). Treatment failure should be identified and managed promptly, with the goal of therapy, even in heavily pretreated patients, being an HIV-1 RNA level below assay detection limits.
Asking the right questions: developing evidence-based strategies for treating HIV in women and children
(2011) Karim, Quarraisha A.; Banegura, Antoine; Cahn, Pedro; Christie, Charmagne D.; Dintruff, Robin; Distel, Michael; Hankins, Catherine; Hellmann, Nicholas; Katabira, Elly; Lehrman, Sandra; Montaner, Julio; Purdon, Scott; Rooney, James F.; Woof, Robin; Heidari, Shirin
In July 2010, the World Health Organization (WHO) issued formal revisions of its guidelines on the use of highly active antiretroviral therapy for HIV. The new guidelines greatly expand eligibility for treatment of adults and children, as well as for pregnant women seeking prophylaxis for vertical HIV transmission. WHO's new recommendations bring the guidelines closer to practices in developed countries, and its shift to earlier treatment alone will increase the number of treatment-eligible people by 50% or more. Scaling up access to HIV treatment is revealing important gaps in our understanding of how best to provide for all those in need. This knowledge gap is especially significant in developing countries, where women and children comprise a majority of those living with HIV infection. Given the magnitude and significance of these populations, the International AIDS Society, through its Industry Liaison Forum, prioritized HIV treatment and prophylaxis of women and children. In March 2010, the International AIDS Society and 15 partners launched a Consensus Statement outlining priority areas in which a relative lack of knowledge impedes delivery of optimal prevention of mother to child transmission (PMTCT) and treatment to women and children. The Consensus Statement, "Asking the Right Questions: Advancing an HIV Research Agenda for Women and Children", makes a special appeal for a more gender-sensitive approach to HIV research at all stages, from conception to design and implementation. It particularly emphasizes research to enhance the understanding of sex-based differences and paediatric needs in treatment uptake and response. In addition to clinical issues, the statement focuses on programmatic research that facilitates access and adherence to antiretroviral regimens. Better coordination of HIV management with sexual and reproductive healthcare delivery is one such approach. We discuss here our knowledge gaps concerning effective, safe PMTCT and treatment for women and children in light of the expansion envisioned by WHO's revised guidelines. The guideline's new goals present an opportunity for advancing the women and children's agenda outlined in the Consensus Statement.
Association between HIV-1 RNA level and CD4 cell count among untreated HIV-infected individuals
(2010) Lima, Viviane D.; Fink, Valeria; Yip, Benjamin; Hogg, Robert S.; Harrigan, Richard P.; Montaner, Julio
Objectives. We examined the significance of plasma HIV-1 RNA levels (or viral load alone) in predicting CD4 cell decline in untreated HIV-infected individuals. Methods. Data were obtained from the British Columbia Centre for Excellence in HIV/AIDS. Participants included all residents who ever had a viral load determination in the province and who had never taken antiretroviral drugs (N = 890). We analyzed a total of 2074 viral load measurements and 2332 CD4 cell counts. Linear mixed-effects models were used to predict CD4 cell decline over time. Results. Longitudinal viral load was strongly associated with CD4 cell decline over time; an average of 1 log10 increase in viral load was associated with a 55-cell/mm3 decrease in CD4 cell count. Conclusions. Our results support the combined use of CD4 cell count and viral load as prognostic markers in HIV-infected individuals before the introduction of antiretroviral therapy.
Determinants of Treatment Access in a Population-based Cohort of HIV-positive Men and Women Living in Argentina
(2008-04-02) Zala, Carlos; Rustad, Clare A; Chan, Keith; Khan, Nabeela I; Beltran, Marcelo; Warley, Eduardo; Ceriotto, Mariana; Druyts, Eric F; Hogg, Robert S; Montaner, Julio; Cahn, Pedro; PUMA Study Group
Objective To report emerging data on the use of highly active antiretroviral therapy (HAART) in Argentina by assessing patterns of HAART access and late vs early treatment initiation in a population-based cohort of adults infected with HIV type-1. Design The Prospective Study on the Use and Monitoring of Antiretroviral Therapy (PUMA) is a study of 883 HIV-positive individuals enrolled in the Argentinean drug treatment program. Individuals were 16 years of age and older and were recruited from 10 clinics across Argentina. Methods Sociodemographic and clinical characteristics were examined using contingency tables (Pearson chi-square test and Fisher exact test) for categoric variables and Wilcoxon rank-sum test for continuous variables. To analyze time to initiation of HAART we used Kaplan-Meier methods and Cox regression. Results Patients who initiated HAART were more likely to be older, have an AIDS-defining illness, be an injection drug user (IDU), have a lower median CD4 cell count, have a higher median viral load, and be less likely to be men who have sex with men (MSM). In multivariate analysis, AIDS-defining illness and plasma viral load were significantly associated with time to starting therapy. Patients who received late access were more likely to be diagnosed with AIDS and have higher median plasma viral loads than those receiving early access. Conclusion Our results indicate that despite free availability of treatment, monitoring, and care in Argentina, a significant proportion of men and women are accessing HAART late in the course of HIV disease. Further characterization of the HIV-positive population will allow for a more comprehensive evaluation of the impact of HAART within the Argentinean drug treatment program.
Examining the evidence on the causal effect of HAART on transmission of HIV using the Bradford Hill criteria
(2013) Nosyk, B.; Audoin, B.; Beyrer, C.; Cahn, Pedro; Granich, R.; Havlir, D.; Katabira, E.; Lange, J.; Lima, V. D.; Patterson, T.; Strathdee, S. A.; Williams, B.; Montaner, Julio
In recent years, evidence has accumulated regarding the ability of HAART to prevent HIV transmission. Early supportive evidence was derived from observational, ecological and population-based studies. More recently, a randomized clinical trial showed that immediate use of HAART led to a 96% decrease in HIV transmission events within HIV serodiscordant heterosexual couples. However, the generalizability of the effect of HAART, and the population-level impact on HIV transmission continues to generate substantial debate. We, therefore, conducted a review of the evidence regarding the preventive effect of HAART on HIV transmission within the context of the Bradford Hill criteria for causality. Taken together, we find the accumulated evidence supporting HIV treatment as prevention meets each of the Bradford Hill criteria for causality. We conclude that the opportunity cost of inaction while waiting for additional evidence on the generalizability of effect in other risk groups is too high. Efforts should be redoubled to mobilize the financial capital and political will to optimize implementation of HIV Treatment as Prevention strategies on a wide scale.
Gender-sensitive reporting in medical research
(2012) Heidari, Shirin; Abdool Karim, Quarraisha; Auerbach, Judith D.; Buitendijk, Simone E.; Cahn, Pedro; Curno, Mirjam J.; Hankins, Catherine; Katabira, Elly; Kippax, Susan; Marlink, Richard; Marsh, Jennifer; Marusic, Ana; Nass, Heidi M.; Montaner, Julio; Pollitzer, Elizabeth; Ruiz-Cantero, Maria Teresa; Sherr, Lorraine; Papa Salif Sow; Squires, Kathleen; Wainberg, Mark A.
Sex and gender differences influence the health and wellbeing of men and women. Although studies have drawn attention to observed differences between women and men across diseases, remarkably little research has been pursued to systematically investigate these underlying sex differences. Women continue to be underrepresented in clinical trials, and even in studies in which both men and women participate, systematic analysis of data to identify potential sex-based differences is lacking. Standards for reporting of clinical trials have been established to ensure provision of complete, transparent and critical information. An important step in addressing the gender imbalance would be inclusion of a gender perspective in the next Consolidated Standards of Reporting Trials (CONSORT) guideline revision. Uniform Requirements for Manuscripts Submitted to Biomedical Journals, as a set of well-recognized and widely used guidelines for authors and biomedical journals, should similarly emphasize the ethical obligation of authors to present data analyzed by gender as a matter of routine. Journal editors are also promoters of ethical research and adequate standards of reporting, and requirements for inclusion of gender analyses should be integrated into editorial policies as a matter of urgency.
Pilot, Randomized Study Assessing Safety, Tolerability and Efficacy of Simplified LPV/r Maintenance Therapy in HIV Patients on the 1 PI-Based Regimen
(2011) Cahn, Pedro; Montaner, Julio; Junod, Patrice; Patterson, Patricia; Krolewiecki, Alejandro J.; Andrade-Villanueva, Jaime; Cassetti, Isabel; Sierra Madero, Juan; Casiro, A. D.; Bortolozzi, Raul; Lupo, Silvana H.; Longo, Nancy; Rampakakis, Emmanouil; Ackad, Nadia; Sampalis, John S.
Objectives To compare the efficacy and safety of an individualized treatment-simplification strategy consisting of switching from a highly-active anti-retroviral treatment (HAART) with a ritonavir-boosted protease inhibitor (PI/r) and 2 nucleoside reverse-transcriptase inhibitors (NRTIs) to lopinavir/ritonavir (LPV/r) monotherapy, with intensification by 2 NRTIs if necessary, to that of continuing their HAART. Methods This is a one-year, randomized, open-label, multi-center study in virologically-suppressed HIV-1-infected adults on their first PI/r-containing treatment, randomized to either LPV/r-monotherapy or continue their current treatment. Treatment efficacy was determined by plasma HIV-1 RNA viral load (VL), time-to-virologic rebound, patient-reported outcomes (PROs) and CD4+T-cell-count changes. Safety was assessed with the incidence of treatment-emergent adverse events (AE). Results Forty-one patients were randomized to LPV/r and 39 to continue their HAART. No statistically-significant differences between the two study groups in demographics and baseline characteristics were observed. At day-360, 71(39:LPV/r;32:HAART) patients completed treatment, while 9(2:LPV/r;7:HAART) discontinued. In a Last Observation Carried Forward Intent-to-Treat analysis, 40(98%) patients on LPV/r and 37(95%) on HAART had VL<200copies/mL (P = 0.61). Time-to-virologic rebound, changes in PROs, CD4+ T-cell-count and VL from baseline, also exhibited no statistically-significant between-group differences. Most frequent AEs were diarrhea (19%), headache (18%) and influenza (16%). Four (10%) patients on LPV/r were intensified with 2 NRTIs, all regaining virologic control. Eight serious AEs were reported by 5(2:LPV/r;3:HAART) patients. Conclusion At day-360, virologic efficacy and safety of LPV/r appears comparable to that of a PI+2NRTIs HAART. These results suggest that our individualized, simplified maintenance strategy with LPV/r-monotherapy and protocol-mandated NRTI re-introduction upon viral rebound, in virologically-suppressed patients merits further prospective long-term evaluation.
Prioritizing CD4 Count Monitoring in Response to ART in Resource-Constrained Settings: A Retrospective Application of Prediction-Based Classification
(2012) Azzoni, Livio; Foulkes, Andrea S.; Liu, Yan; Li, Xin; Johnson, Mark; Smith, Charles; Kamarulzaman, Adeeba; Montaner, Julio; Mounzer, Joseph; Saag, Michael; Cahn, Pedro; Cesar, Carina; Krolewiecki, Alejandro J.; Sanne, Ian; Montaner, Luis J.
Background Global programs of anti-HIV treatment depend on sustained laboratory capacity to assess treatment initiation thresholds and treatment response over time. Currently, there is no valid alternative to CD4 count testing for monitoring immunologic responses to treatment, but laboratory cost and capacity limit access to CD4 testing in resource-constrained settings. Thus, methods to prioritize patients for CD4 count testing could improve treatment monitoring by optimizing resource allocation. Methods and Findings Using a prospective cohort of HIV-infected patients (n=1,956) monitored upon antiretroviral therapy initiation in seven clinical sites with distinct geographical and socio-economic settings, we retrospectively apply a novel prediction-based classification (PBC) modeling method. The model uses repeatedly measured biomarkers (white blood cell count and lymphocyte percent) to predict CD4+ T cell outcome through first-stage modeling and subsequent classification based on clinically relevant thresholds (CD4+ T cell count of 200 or 350 cells/µl). The algorithm correctly classified 90% (cross-validation estimate=91.5%, standard deviation [SD]=4.5%) of CD4 count measurements <200 cells/µl in the first year of follow-up; if laboratory testing is applied only to patients predicted to be below the 200-cells/µl threshold, we estimate a potential savings of 54.3% (SD=4.2%) in CD4 testing capacity. A capacity savings of 34% (SD=3.9%) is predicted using a CD4 threshold of 350 cells/µl. Similar results were obtained over the 3 y of follow-up available (n=619). Limitations include a need for future economic healthcare outcome analysis, a need for assessment of extensibility beyond the 3-y observation time, and the need to assign a false positive threshold. Conclusions Our results support the use of PBC modeling as a triage point at the laboratory, lessening the need for laboratory-based CD4+ T cell count testing; implementation of this tool could help optimize the use of laboratory resources, directing CD4 testing towards higher-risk patients. However, further prospective studies and economic analyses are needed to demonstrate that the PBC model can be effectively applied in clinical settings.
Should active recruitment of health workers from Sub-Saharan Africa be viewed as a crime?
(2008) Mills, Edward J.; Schabas, William A.; Volmink, Jimmy; Walker, Roderick; Ford, Nathan; Katabira, Elly; Anema, Aranka; Joffres, Michel; Cahn, Pedro; Montaner, Julio
Shortages of health-care staff are endemic in sub-Saharan Africa (table). 1 Overall, there is one physician for every 8000 people in the region. In the worst affected countries, such as Malawi, the physician-to-population ratio is just 0·02 for every 1000 (one per 50 000). There are also huge disparities between rural and urban areas: rural parts of South Africa have 14 times fewer doctors than the national average. 2 These numbers are very different to those in developed countries: the UK, for example, has over 100 times more physicians per population than Malawi. 3 Furthermore, almost one in ten doctors working in the UK are from Africa. The insufficiency of health staff to provide even basic services is one of the most pressing impediments to health-care delivery in resource-poor settings. The consequences are clearly shown by the inverse relation that exists between health-care worker density and mortality.
Time to act: global apathy towards HIV/AIDS is a crime against humanity
(2002-11) Hogg, Robert; Cahn, Pedro; Katabira, Elly; Lange, Joep; Samuel, NM; O'Shaughnessy, Michael; Vella, Stefano; Wainberg, Mark; Montaner, Julio
“There are some people who say that in Africa, people will not be able to take these drugs because they cannot tell time. I may not have a watch, but I can assure you that since I started taking my triple therapy in August last year, I haven't missed one dose.” Fred Minandi, a farmer from Malawi
Universal access in the fight against HIV/AIDS
(2010) Girard, Françoise; Ford, Nathan; Montaner, Julio; Cahn, Pedro; Katabira, Elly
In 2006, all United Nations member states committed themselves to the goal of universal access to comprehensive programs for HIV prevention, treatment, care, and support by 2010 (1). This commitment has inspired national and international responses to achieve impressive results. Unfortunately, it is now clear that the global community has failed to deliver on the universal access pledge. Worse, the global AIDS response is currently under attack. What have we learned, and where should we go from here?

Browsing by Author "Montaner, Julio"

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