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1.
Transgend Health ; 8(6): 534-541, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38130987

ABSTRACT

Purpose: The purpose of this study was to determine if human immunodeficiency virus (HIV) practitioners offer gender-affirming hormone therapy (GAHT) to their transgender patients living with HIV, as previous studies have shown that these patients are more likely to be virally suppressed and retained in care. Methods: We conducted an online survey sent to 2570 HIV practitioners who attended an International Antiviral Society-USA event between 2017 and 2019. We also assessed demographics, transgender care training, comfort, prescribing practices, and knowledge. Results: Respondents (N=385) were mainly primary care (49%) and infectious disease (ID)/HIV (42%) practitioners. Fifty-seven percent prescribed GAHT to transgender people living with HIV, but only 7% received formal training. Thirty-five percent were ID/HIV, 60% were primary care, and 5% were other specialty practitioners. Most felt that it would be beneficial to have formal education in GAHT practices during training (83%). There were statistically significant differences in GAHT education, experiences, knowledge, and interest in future training and prescribing by health care specialty. Commonly cited barriers to providing therapy included lack of training (33%), lack of transgender people living with HIV in practice (18%), and lack of qualified mental health professionals (15%). Conclusion: This survey is the first to assess GAHT practices among HIV practitioners from across the United States. The majority of those surveyed prescribe GAHT to their transgender patients living with HIV. Although most felt comfortable doing so, few had formal training and knowledge scores were low. We advocate for the integration of GAHT education into formal training programs and offer resources for those who wish to pursue education.

2.
JAMA ; 329(1): 63-84, 2023 01 03.
Article in English | MEDLINE | ID: mdl-36454551

ABSTRACT

Importance: Recent advances in treatment and prevention of HIV warrant updated recommendations to guide optimal practice. Objective: Based on a critical evaluation of new data, to provide clinicians with recommendations on use of antiretroviral drugs for the treatment and prevention of HIV, laboratory monitoring, care of people aging with HIV, substance use disorder and HIV, and new challenges in people with HIV, including COVID-19 and monkeypox virus infection. Evidence Review: A panel of volunteer expert physician scientists were appointed to update the 2020 consensus recommendations. Relevant evidence in the literature (PubMed and Embase searches, which initially yielded 7891 unique citations, of which 834 were considered relevant) and studies presented at peer-reviewed scientific conferences between January 2020 and October 2022 were considered. Findings: Initiation of antiretroviral therapy (ART) is recommended as soon as possible after diagnosis of HIV. Barriers to care should be addressed, including ensuring access to ART and adherence support. Integrase strand transfer inhibitor-containing regimens remain the mainstay of initial therapy. For people who have achieved viral suppression with a daily oral regimen, long-acting injectable therapy with cabotegravir plus rilpivirine given as infrequently as every 2 months is now an option. Weight gain and metabolic complications have been linked to certain antiretroviral medications; novel strategies to ameliorate these complications are needed. Management of comorbidities throughout the life span is increasingly important, because people with HIV are living longer and confronting the health challenges of aging. In addition, management of substance use disorder in people with HIV requires an evidence-based, integrated approach. Options for preexposure prophylaxis include oral medications (tenofovir disoproxil fumarate or tenofovir alafenamide plus emtricitabine) and, for the first time, a long-acting injectable agent, cabotegravir. Recent global health emergencies, like the SARS-CoV-2 pandemic and monkeypox virus outbreak, continue to have a major effect on people with HIV and the delivery of services. To address these and other challenges, an equity-based approach is essential. Conclusions and Relevance: Advances in treatment and prevention of HIV continue to improve outcomes, but challenges and opportunities remain.


Subject(s)
Anti-Retroviral Agents , HIV Infections , Adult , Humans , Anti-HIV Agents/therapeutic use , Anti-Retroviral Agents/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/prevention & control , HIV Infections/drug therapy , HIV Infections/prevention & control , Pharmaceutical Preparations , SARS-CoV-2
3.
JAMA ; 324(16): 1651-1669, 2020 10 27.
Article in English | MEDLINE | ID: mdl-33052386

ABSTRACT

Importance: Data on the use of antiretroviral drugs, including new drugs and formulations, for the treatment and prevention of HIV infection continue to guide optimal practices. Objective: To evaluate new data and incorporate them into current recommendations for initiating HIV therapy, monitoring individuals starting on therapy, changing regimens, preventing HIV infection for those at risk, and special considerations for older people with HIV. Evidence Review: New evidence was collected since the previous International Antiviral (formerly AIDS) Society-USA recommendations in 2018, including data published or presented at peer-reviewed scientific conferences through August 22, 2020. A volunteer panel of 15 experts in HIV research and patient care considered these data and updated previous recommendations. Findings: From 5316 citations about antiretroviral drugs identified, 549 were included to form the evidence basis for these recommendations. Antiretroviral therapy is recommended as soon as possible for all individuals with HIV who have detectable viremia. Most patients can start with a 3-drug regimen or now a 2-drug regimen, which includes an integrase strand transfer inhibitor. Effective options are available for patients who may be pregnant, those who have specific clinical conditions, such as kidney, liver, or cardiovascular disease, those who have opportunistic diseases, or those who have health care access issues. Recommended for the first time, a long-acting antiretroviral regimen injected once every 4 weeks for treatment or every 8 weeks pending approval by regulatory bodies and availability. For individuals at risk for HIV, preexposure prophylaxis with an oral regimen is recommended or, pending approval by regulatory bodies and availability, with a long-acting injection given every 8 weeks. Monitoring before and during therapy for effectiveness and safety is recommended. Switching therapy for virological failure is relatively rare at this time, and the recommendations for switching therapies for convenience and for other reasons are included. With the survival benefits provided by therapy, recommendations are made for older individuals with HIV. The current coronavirus disease 2019 pandemic poses particular challenges for HIV research, care, and efforts to end the HIV epidemic. Conclusion and Relevance: Advances in HIV prevention and management with antiretroviral drugs continue to improve clinical care and outcomes among individuals at risk for and with HIV.


Subject(s)
Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy , HIV Infections/prevention & control , AIDS-Related Opportunistic Infections/drug therapy , Age Factors , Anti-Retroviral Agents/economics , Betacoronavirus , COVID-19 , Comorbidity , Coronavirus Infections/epidemiology , Drug Administration Schedule , Drug Costs , Drug Resistance, Viral/genetics , Drug Substitution/standards , Drug Therapy, Combination/methods , Female , HIV Infections/blood , HIV Infections/diagnosis , Humans , International Agencies , Male , Pandemics , Pneumonia, Viral/epidemiology , Polypharmacy , Pre-Exposure Prophylaxis/methods , Pregnancy , Pregnancy Complications, Infectious/drug therapy , RNA, Viral/blood , SARS-CoV-2 , Societies, Medical , United States , Viral Load/genetics
4.
PLoS One ; 15(9): e0238375, 2020.
Article in English | MEDLINE | ID: mdl-32881916

ABSTRACT

BACKGROUND AND OBJECTIVES: Less than 10 percent of the more than one million people vulnerable to HIV are using pre-exposure prophylaxis (PrEP). Practitioners are critical to ensuring the delivery of PrEP across care settings. In this study, we target a group of prescribers focused on providing HIV care and seeking up-to-date information about HIV. We assessed their experiences prescribing PrEP, whether these experiences differed by clinical specialty, and examined associations between willingness to prescribe PrEP as a "best first step" and different hypothetical prescribing scenarios. SETTING AND METHODS: Between March and May 2015, we circulated a paper survey to 954 participants ((652 of whom met our inclusion criteria of being independent prescribers and 519 of those (80%) responded to the survey)) at continuing medical education advanced-level HIV courses in five locations across the US on practitioner practices and preferences of PrEP. We employed multivariable logistic regression analysis for binary and collapsed ordinal outcomes. RESULTS: Among this highly motivated group of practitioners, only 54% reported ever prescribing PrEP. Internal medicine practitioners were 1.6 times more likely than infectious disease practitioners to have prescribed PrEP (95% CI: 0.99-2.60, p = .0524) and age, years of training, and sex were significantly associated with prescribing experience. Based on clinical vignettes describing different hypothetical prescribing scenarios, practitioners who viewed PrEP as the first clinical step for persons who inject drugs (PWID) were twice as likely to have also considered PrEP as the first clinical option for safer conception, and vice-a-versa (95% CI: 1.4-3.2, p < .001). Practitioners considering PrEP as the first preventive option for MSM were nearly six times as likely to also consider PrEP as the first clinical step for PWID, and vice-a-versa (95% CI: 2.28-13.56, p = .0002). CONCLUSIONS: Our findings indicate that even among a subset of HIV-focused practitioners, PrEP prescribing is not routine. This group of practitioners could be an optimal group to engage individuals that could most benefit from PrEP.


Subject(s)
HIV Infections/prevention & control , Physicians/psychology , Pre-Exposure Prophylaxis , Prescriptions/statistics & numerical data , Adult , Female , HIV Infections/pathology , Homosexuality, Male , Humans , Logistic Models , Male , Middle Aged , Odds Ratio , Surveys and Questionnaires , United States
5.
Open Forum Infect Dis ; 6(3): ofz082, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30895208

ABSTRACT

BACKGROUND: We sought to characterize human immunodeficiency virus (HIV) practitioners' recommendations to patients regarding treatment as prevention, pre-exposure prophylaxis (PrEP) and condom use among persons with HIV (PWH) with viral suppression and individuals receiving PrEP. METHODS: A brief survey about counseling practices was distributed electronically to previous attendees of an International Antiviral Society-USA continuing medical education activity. Descriptive analyses were performed for all questions. Pearson χ2 tests were used to identify potential differences in counseling practices based on sex, degree/license, years in practice, number of PWH cared for in the past year, and practice location. RESULTS: Of the 3238 persons surveyed, 478 (15%) responded. 65% were female, 47% were physicians, 78% had been in practice ≥6 years, and 52% had cared for >100 PWH in the last year. Of the respondents, 51% (95% confidence interval, 46.8%-56.0%) agreed that the evidence "supports, strongly supports or proves" that condomless sex with a PWH with viral suppression does not lead to HIV transmission, and 76% (72.2%-80.0%) commonly or always recommend condoms for such patients. Although 42% (95% confidence interval, 37.0%-46.0%) of respondents said the evidence "supports, strongly supports or proves" that condomless sex involving a person at risk for HIV infection receiving PrEP does not lead to HIV transmission, 81% (77.3%-84.5%) commonly or always recommend condom use for such patients. Responses differed significantly by practitioner experience, region, sex and degree. CONCLUSIONS: Although many practitioners caring for individuals with and at risk for HIV infection acknowledge that successful treatment or PrEP prevents transmission, the majority of practitioners commonly or always recommend condom use.

6.
Clin Infect Dis ; 68(2): 177-187, 2019 01 07.
Article in English | MEDLINE | ID: mdl-30052811

ABSTRACT

Background: Contemporary antiretroviral therapies (ART) and management strategies have diminished both human immunodeficiency virus (HIV) treatment failure and the acquired resistance to drugs in resource-rich regions, but transmission of drug-resistant viruses has not similarly decreased. In low- and middle-income regions, ART roll-out has improved outcomes, but has resulted in increasing acquired and transmitted resistances. Our objective was to review resistance to ART drugs and methods to detect it, and to provide updated recommendations for testing and monitoring for drug resistance in HIV-infected individuals. Methods: A volunteer panel of experts appointed by the International Antiviral (formerly AIDS) Society-USA reviewed relevant peer-reviewed data that were published or presented at scientific conferences. Recommendations were rated according to the strength of the recommendation and quality of the evidence, and reached by full panel consensus. Results: Resistance testing remains a cornerstone of ART. It is recommended in newly-diagnosed individuals and in patients in whom ART has failed. Testing for transmitted integrase strand-transfer inhibitor resistance is currently not recommended, but this may change as more resistance emerges with widespread use. Sanger-based and next-generation sequencing approaches are each suited for genotypic testing. Testing for minority variants harboring drug resistance may only be considered if treatments depend on a first-generation nonnucleoside analogue reverse transcriptase inhibitor. Different HIV-1 subtypes do not need special considerations regarding resistance testing. Conclusions: Testing for HIV drug resistance in drug-naive individuals and in patients in whom antiretroviral drugs are failing, and the appreciation of the role of testing, are crucial to the prevention and management of failure of ART.


Subject(s)
Anti-HIV Agents/pharmacology , Drug Resistance, Viral/physiology , HIV Infections/drug therapy , HIV Infections/virology , HIV-1/drug effects , Internationality , Developing Countries , Humans , Societies, Scientific , United States
8.
JAMA ; 320(4): 379-396, 2018 07 24.
Article in English | MEDLINE | ID: mdl-30043070

ABSTRACT

Importance: Antiretroviral therapy (ART) is the cornerstone of prevention and management of HIV infection. Objective: To evaluate new data and treatments and incorporate this information into updated recommendations for initiating therapy, monitoring individuals starting therapy, changing regimens, and preventing HIV infection for individuals at risk. Evidence Review: New evidence collected since the International Antiviral Society-USA 2016 recommendations via monthly PubMed and EMBASE literature searches up to April 2018; data presented at peer-reviewed scientific conferences. A volunteer panel of experts in HIV research and patient care considered these data and updated previous recommendations. Findings: ART is recommended for virtually all HIV-infected individuals, as soon as possible after HIV diagnosis. Immediate initiation (eg, rapid start), if clinically appropriate, requires adequate staffing, specialized services, and careful selection of medical therapy. An integrase strand transfer inhibitor (InSTI) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is generally recommended for initial therapy, with unique patient circumstances (eg, concomitant diseases and conditions, potential for pregnancy, cost) guiding the treatment choice. CD4 cell count, HIV RNA level, genotype, and other laboratory tests for general health and co-infections are recommended at specified points before and during ART. If a regimen switch is indicated, treatment history, tolerability, adherence, and drug resistance history should first be assessed; 2 or 3 active drugs are recommended for a new regimen. HIV testing is recommended at least once for anyone who has ever been sexually active and more often for individuals at ongoing risk for infection. Preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine and appropriate monitoring is recommended for individuals at risk for HIV. Conclusions and Relevance: Advances in HIV prevention and treatment with antiretroviral drugs continue to improve clinical management and outcomes for individuals at risk for and living with HIV.


Subject(s)
Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy , HIV Infections/prevention & control , Adult , Advisory Committees , Diagnosis, Differential , Fees, Pharmaceutical , HIV Infections/diagnosis , Humans , Time-to-Treatment
9.
JAMA ; 316(2): 191-210, 2016 Jul 12.
Article in English | MEDLINE | ID: mdl-27404187

ABSTRACT

IMPORTANCE: New data and therapeutic options warrant updated recommendations for the use of antiretroviral drugs (ARVs) to treat or to prevent HIV infection in adults. OBJECTIVE: To provide updated recommendations for the use of antiretroviral therapy in adults (aged ≥18 years) with established HIV infection, including when to start treatment, initial regimens, and changing regimens, along with recommendations for using ARVs for preventing HIV among those at risk, including preexposure and postexposure prophylaxis. EVIDENCE REVIEW: A panel of experts in HIV research and patient care convened by the International Antiviral Society-USA reviewed data published in peer-reviewed journals, presented by regulatory agencies, or presented as conference abstracts at peer-reviewed scientific conferences since the 2014 report, for new data or evidence that would change previous recommendations or their ratings. Comprehensive literature searches were conducted in the PubMed and EMBASE databases through April 2016. Recommendations were by consensus, and each recommendation was rated by strength and quality of the evidence. FINDINGS: Newer data support the widely accepted recommendation that antiretroviral therapy should be started in all individuals with HIV infection with detectable viremia regardless of CD4 cell count. Recommended optimal initial regimens for most patients are 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI). Other effective regimens include nonnucleoside reverse transcriptase inhibitors or boosted protease inhibitors with 2 NRTIs. Recommendations for special populations and in the settings of opportunistic infections and concomitant conditions are provided. Reasons for switching therapy include convenience, tolerability, simplification, anticipation of potential new drug interactions, pregnancy or plans for pregnancy, elimination of food restrictions, virologic failure, or drug toxicities. Laboratory assessments are recommended before treatment, and monitoring during treatment is recommended to assess response, adverse effects, and adherence. Approaches are recommended to improve linkage to and retention in care are provided. Daily tenofovir disoproxil fumarate/emtricitabine is recommended for use as preexposure prophylaxis to prevent HIV infection in persons at high risk. When indicated, postexposure prophylaxis should be started as soon as possible after exposure. CONCLUSIONS AND RELEVANCE: Antiretroviral agents remain the cornerstone of HIV treatment and prevention. All HIV-infected individuals with detectable plasma virus should receive treatment with recommended initial regimens consisting of an InSTI plus 2 NRTIs. Preexposure prophylaxis should be considered as part of an HIV prevention strategy for at-risk individuals. When used effectively, currently available ARVs can sustain HIV suppression and can prevent new HIV infection. With these treatment regimens, survival rates among HIV-infected adults who are retained in care can approach those of uninfected adults.


Subject(s)
Anti-Retroviral Agents/therapeutic use , HIV Infections/prevention & control , AIDS-Related Opportunistic Infections , Adolescent , Adult , Aged , CD4 Lymphocyte Count , Drug Therapy, Combination , Female , HIV Infections/drug therapy , HIV-1 , Humans , Male , Middle Aged , Post-Exposure Prophylaxis , Pre-Exposure Prophylaxis , Pregnancy , Prognosis , Treatment Failure , Viral Load , Viremia , Young Adult
10.
JAMA ; 312(4): 410-25, 2014.
Article in English | MEDLINE | ID: mdl-25038359

ABSTRACT

IMPORTANCE: New data and antiretroviral regimens expand treatment choices in resource-rich settings and warrant an update of recommendations to treat adults infected with human immunodeficiency virus (HIV). OBJECTIVE: To provide updated treatment recommendations for adults with HIV, emphasizing when to start treatment; what treatment to start; the use of laboratory monitoring tools; and managing treatment failure, switches, and simplification. DATA SOURCES, STUDY SELECTION, AND DATA SYNTHESIS: An International Antiviral Society-USA panel of experts in HIV research and patient care considered previous data and reviewed new data since the 2012 update with literature searches in PubMed and EMBASE through June 2014. Recommendations and ratings were based on the quality of evidence and consensus. RESULTS: Antiretroviral therapy is recommended for all adults with HIV infection. Evidence for benefits of treatment and quality of available data increase at lower CD4 cell counts. Recommended initial regimens include 2 nucleoside reverse transcriptase inhibitors (NRTIs; abacavir/lamivudine or tenofovir disoproxil fumarate/emtricitabine) and a third single or boosted drug, which should be an integrase strand transfer inhibitor (dolutegravir, elvitegravir, or raltegravir), a nonnucleoside reverse transcriptase inhibitor (efavirenz or rilpivirine) or a boosted protease inhibitor (darunavir or atazanavir). Alternative regimens are available. Boosted protease inhibitor monotherapy is generally not recommended, but NRTI-sparing approaches may be considered. New guidance for optimal timing of monitoring of laboratory parameters is provided. Suspected treatment failure warrants rapid confirmation, performance of resistance testing while the patient is receiving the failing regimen, and evaluation of reasons for failure before consideration of switching therapy. Regimen switches for adverse effects, convenience, or to reduce costs should not jeopardize antiretroviral potency. CONCLUSIONS AND RELEVANCE: After confirmed diagnosis of HIV infection, antiretroviral therapy should be initiated in all individuals who are willing and ready to start treatment. Regimens should be selected or changed based on resistance test results with consideration of dosing frequency, pill burden, adverse toxic effect profiles, comorbidities, and drug interactions.


Subject(s)
Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , Adult , Anti-HIV Agents/administration & dosage , Anti-HIV Agents/adverse effects , CD4 Lymphocyte Count , Drug Costs , Drug Resistance, Viral , Drug Therapy, Combination , HIV Infections/diagnosis , Humans , Treatment Failure
11.
JAMA ; 308(4): 387-402, 2012 Jul 25.
Article in English | MEDLINE | ID: mdl-22820792

ABSTRACT

CONTEXT: New trial data and drug regimens that have become available in the last 2 years warrant an update to guidelines for antiretroviral therapy (ART) in human immunodeficiency virus (HIV)-infected adults in resource-rich settings. OBJECTIVE: To provide current recommendations for the treatment of adult HIV infection with ART and use of laboratory-monitoring tools. Guidelines include when to start therapy and with what drugs, monitoring for response and toxic effects, special considerations in therapy, and managing antiretroviral failure. DATA SOURCES, STUDY SELECTION, AND DATA EXTRACTION: Data that had been published or presented in abstract form at scientific conferences in the past 2 years were systematically searched and reviewed by an International Antiviral Society-USA panel. The panel reviewed available evidence and formed recommendations by full panel consensus. DATA SYNTHESIS: Treatment is recommended for all adults with HIV infection; the strength of the recommendation and the quality of the evidence increase with decreasing CD4 cell count and the presence of certain concurrent conditions. Recommended initial regimens include 2 nucleoside reverse transcriptase inhibitors (tenofovir/emtricitabine or abacavir/lamivudine) plus a nonnucleoside reverse transcriptase inhibitor (efavirenz), a ritonavir-boosted protease inhibitor (atazanavir or darunavir), or an integrase strand transfer inhibitor (raltegravir). Alternatives in each class are recommended for patients with or at risk of certain concurrent conditions. CD4 cell count and HIV-1 RNA level should be monitored, as should engagement in care, ART adherence, HIV drug resistance, and quality-of-care indicators. Reasons for regimen switching include virologic, immunologic, or clinical failure and drug toxicity or intolerance. Confirmed treatment failure should be addressed promptly and multiple factors considered. CONCLUSION: New recommendations for HIV patient care include offering ART to all patients regardless of CD4 cell count, changes in therapeutic options, and modifications in the timing and choice of ART in the setting of opportunistic illnesses such as cryptococcal disease and tuberculosis.


Subject(s)
Anti-Retroviral Agents/administration & dosage , HIV Infections/drug therapy , AIDS-Related Opportunistic Infections , Adult , Anti-Retroviral Agents/adverse effects , CD4 Lymphocyte Count , Drug Administration Schedule , Drug Therapy, Combination , Female , HIV Infections/complications , Hepatitis B/complications , Hepatitis C/complications , Humans , Male , Medication Adherence , Pregnancy , Pregnancy Complications, Infectious/drug therapy , Quality of Health Care , RNA, Viral/blood , Societies, Medical , Treatment Failure
12.
Arch Intern Med ; 171(9): 840-6, 2011 May 09.
Article in English | MEDLINE | ID: mdl-21555662

ABSTRACT

BACKGROUND: Pharmaceutical and medical device company funding supports up to 60% of accredited continuing medical education (CME) costs in the United States. Some have proposed measures to limit the size, scope, and potential influence of commercial support for CME activities. We sought to determine whether participants at CME activities perceive that commercial support introduces bias, whether this is affected by the amount or type of support, and whether they would be willing to accept higher fees or fewer amenities to decrease the need for such funding. METHODS: We delivered a structured questionnaire to 1347 participants at a series of 5 live CME activities about the impact of commercial support on bias and their willingness to pay additional amounts to eliminate the need for commercial support. RESULTS: Of the 770 respondents (a 57% response rate), most (88%) believed that commercial support introduces bias, with greater amounts of support introducing greater risk of bias. Only 15%, however, supported elimination of commercial support from CME activities, and less than half (42%) were willing to pay increased registration fees to decrease or eliminate commercial support. Participants who perceived bias from commercial support more frequently agreed to increase registration fees to decrease such support (2- to 3-fold odds ratio). Participants greatly underestimated the costs of ancillary activities, such as food, as well as the degree of support actually provided by commercial funding. CONCLUSION: Although the medical professionals responding to this survey were concerned about bias introduced from commercial funding of CME, many were not willing to pay higher fees to offset or eliminate such funding sources.


Subject(s)
Attitude of Health Personnel , Drug Industry , Education, Medical, Continuing/economics , Financial Support , Health Knowledge, Attitudes, Practice , Bias , Commerce , Female , Humans , Male , Surveys and Questionnaires
13.
JAMA ; 304(3): 321-33, 2010 Jul 21.
Article in English | MEDLINE | ID: mdl-20639566

ABSTRACT

CONTEXT: Recent data regarding the consequences of untreated human immunodeficiency virus (HIV) infection and the expansion of treatment choices for antiretroviral-naive 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 HIV-infected 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 < or = 500/microL, for all symptomatic patients, and those with specific conditions and comorbidities. Therapy should be considered for asymptomatic patients with CD4 cell count > 500/microL. 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.


Subject(s)
Anti-Retroviral Agents/administration & dosage , HIV Infections/drug therapy , HIV-1 , Adult , Anti-Retroviral Agents/adverse effects , CD4 Lymphocyte Count , Drug Administration Schedule , Humans , RNA, Viral/blood , Treatment Failure , Viral Load
14.
JAMA ; 300(5): 555-70, 2008 Aug 06.
Article in English | MEDLINE | ID: mdl-18677028

ABSTRACT

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.


Subject(s)
Anti-HIV Agents/administration & dosage , Antiretroviral Therapy, Highly Active/standards , HIV Infections/drug therapy , AIDS Serodiagnosis/standards , AIDS-Associated Nephropathy , AIDS-Related Opportunistic Infections , Adult , CD4 Lymphocyte Count , Comorbidity , Drug Monitoring , Drug Resistance, Multiple, Viral , Evidence-Based Medicine , Female , HIV Infections/diagnosis , HIV-1/pathogenicity , Humans , Male , Monitoring, Immunologic , Pregnancy , Pregnancy Complications, Infectious , Risk Assessment , Treatment Failure , Viral Load
15.
Clin Infect Dis ; 47(2): 266-85, 2008 Jul 15.
Article in English | MEDLINE | ID: mdl-18549313

ABSTRACT

Resistance to antiretroviral drugs remains an important limitation to successful human immunodeficiency virus type 1 (HIV-1) therapy. Resistance testing can improve treatment outcomes for infected individuals. The availability of new drugs from various classes, standardization of resistance assays, and the development of viral tropism tests necessitate new guidelines for resistance testing. The International AIDS Society-USA convened a panel of physicians and scientists with expertise in drug-resistant HIV-1, drug management, and patient care to review recently published data and presentations at scientific conferences and to provide updated recommendations. Whenever possible, resistance testing is recommended at the time of HIV infection diagnosis as part of the initial comprehensive patient assessment, as well as in all cases of virologic failure. Tropism testing is recommended whenever the use of chemokine receptor 5 antagonists is contemplated. As the roll out of antiretroviral therapy continues in developing countries, drug resistance monitoring for both subtype B and non-subtype B strains of HIV will become increasingly important.


Subject(s)
Anti-HIV Agents/pharmacology , Drug Resistance, Viral , HIV Infections/drug therapy , HIV-1/drug effects , Microbial Sensitivity Tests/methods , Adult , Anti-HIV Agents/therapeutic use , CCR5 Receptor Antagonists , Drug Resistance, Viral/physiology , Female , HIV Fusion Inhibitors/pharmacology , HIV Infections/epidemiology , HIV-1/genetics , HIV-1/physiology , Human Immunodeficiency Virus Proteins/drug effects , Human Immunodeficiency Virus Proteins/genetics , Humans , Integrase Inhibitors/pharmacology , Mutation , Pregnancy , Protease Inhibitors/pharmacology , Reverse Transcriptase Inhibitors/pharmacology , Treatment Failure , Tropism
16.
Top HIV Med ; 16(3): 266-85, 2008.
Article in English | MEDLINE | ID: mdl-19856548

ABSTRACT

Resistance to antiretroviral drugs remains an important limitation to successful human immunodeficiency virus type 1 (HIV-1) therapy. Resistance testing can improve treatment outcomes for infected individuals. The availability of new drugs from various classes, standardization of resistance assays, and the development of viral tropism tests necessitate new guidelines for resistance testing. The International AIDS Society-USA convened a panel of physicians and scientists with expertise in drug-resistant HIV-1, drug management, and patient care to review recently published data and presentations at scientific conferences and to provide updated recommendations. Whenever possible, resistance testing is recommended at the time of HIV infection diagnosis as part of the initial comprehensive patient assessment, as well as in all cases of virologic failure. Tropism testing is recommended whenever the use of chemokine receptor 5 antagonists is contemplated. As the roll out of antiretroviral therapy continues in developing countries, drug resistance monitoring for both subtype B and non-subtype B strains of HIV will become increasingly important.

17.
Top HIV Med ; 14(3): 827-43, 2006.
Article in English | MEDLINE | ID: mdl-17016878

ABSTRACT

CONTEXT: Guidelines for antiretroviral therapy are important for clinicians worldwide given the complexity of the field and the varied clinical situations in which these agents are used. The International AIDS Society-USA panel has updated its recommendations as warranted by new developments in the field. OBJECTIVE: To provide physicians and other human immunodeficiency virus (HIV) clinicians with current recommendations for the use of antiretroviral therapy in HIV-infected adults in circumstances for which there is relatively unrestricted access to drugs and monitoring tools. The recommendations are centered on 4 key issues: when to start antiretroviral therapy; what to start; when to change; and what to change. Antiretroviral therapy in special circumstances is also described. DATA SOURCES AND STUDY SELECTION: A 16-member noncompensated panel was appointed, based on expertise in HIV research and patient care internationally. Data published or presented at selected scientific conferences from mid 2004 through May 2006 were identified and reviewed by all members of the panel. DATA EXTRACTION AND SYNTHESIS: Data that might change previous guidelines were identified and reviewed. New guidelines were drafted by a writing committee and reviewed by the entire panel. CONCLUSIONS: Antiretroviral therapy in adults continues to evolve rapidly, making delivery of state-of-the-art care challenging. Initiation of therapy continues to be recommended in all symptomatic persons and in asymptomatic persons after the CD4 cell count falls below 350/microL and before it declines to 200/microL. A nonnucleoside reverse transcriptase inhibitor or a protease inhibitor boosted with low-dose ritonavir each combined with 2 nucleoside (or nucleotide) reverse transcriptase inhibitors is recommended with choice being based on the individual patient profile. Therapy should be changed when toxicity or intolerance mandate it or when treatment failure is documented. The virologic target for patients with treatment failure is now a plasma HIV-1 RNA level below 50 copies/mL. Adherence to antiretroviral therapy in the short-term and the long-term is crucial for treatment success and must be continually reinforced.

18.
JAMA ; 296(7): 827-43, 2006 Aug 16.
Article in English | MEDLINE | ID: mdl-16905788

ABSTRACT

CONTEXT: Guidelines for antiretroviral therapy are important for clinicians worldwide given the complexity of the field and the varied clinical situations in which these agents are used. The International AIDS Society-USA panel has updated its recommendations as warranted by new developments in the field. OBJECTIVE: To provide physicians and other human immunodeficiency virus (HIV) clinicians with current recommendations for the use of antiretroviral therapy in HIV-infected adults in circumstances for which there is relatively unrestricted access to drugs and monitoring tools. The recommendations are centered on 4 key issues: when to start antiretroviral therapy; what to start; when to change; and what to change. Antiretroviral therapy in special circumstances is also described. DATA SOURCES AND STUDY SELECTION: A 16-member noncompensated panel was appointed, based on expertise in HIV research and patient care internationally. Data published or presented at selected scientific conferences from mid 2004 through May 2006 were identified and reviewed by all members of the panel. DATA EXTRACTION AND SYNTHESIS: Data that might change previous guidelines were identified and reviewed. New guidelines were drafted by a writing committee and reviewed by the entire panel. CONCLUSIONS: Antiretroviral therapy in adults continues to evolve rapidly, making delivery of state-of-the-art care challenging. Initiation of therapy continues to be recommended in all symptomatic persons and in asymptomatic persons after the CD4 cell count falls below 350/microL and before it declines to 200/microL. A nonnucleoside reverse transcriptase inhibitor or a protease inhibitor boosted with low-dose ritonavir each combined with 2 nucleoside (or nucleotide) reverse transcriptase inhibitors is recommended with choice being based on the individual patient profile. Therapy should be changed when toxicity or intolerance mandate it or when treatment failure is documented. The virologic target for patients with treatment failure is now a plasma HIV-1 RNA level below 50 copies/mL. Adherence to antiretroviral therapy in the short-term and the long-term is crucial for treatment success and must be continually reinforced.


Subject(s)
Antiretroviral Therapy, Highly Active , HIV Infections/drug therapy , Adult , Antiretroviral Therapy, Highly Active/standards , Drug Monitoring , Drug Resistance, Viral , Female , HIV/drug effects , HIV/genetics , HIV Infections/complications , HIV Infections/immunology , Hepatitis B/complications , Hepatitis C/complications , Humans , Male , Pregnancy , Pregnancy Complications, Infectious/drug therapy , Tuberculosis/complications , Viral Load
19.
JAMA ; 292(2): 251-65, 2004 Jul 14.
Article in English | MEDLINE | ID: mdl-15249575

ABSTRACT

CONTEXT: Substantial changes in the field of human immunodeficiency virus (HIV) treatment have occurred in the last 2 years, prompting revision of the guidelines for antiretroviral management of adults with established HIV infection. OBJECTIVE: To update recommendations for physicians who provide HIV care regarding when to start antiretroviral therapy, what drugs to start with, when to change drug regimens, and what drug regimens to switch to after therapy fails. DATA SOURCES: Evidence was identified and reviewed by a 16-member noncompensated panel of physicians with expertise in HIV-related basic science and clinical research, antiretroviral therapy, and HIV patient care. The panel was designed to have broad US and international representation for areas with adequate access to antiretroviral management. STUDY SELECTION: Evidence considered included published basic science, clinical research, and epidemiological data (identified by experts in the field or extracted through MEDLINE searches using terms relevant to antiretroviral therapy) and abstracts from HIV-oriented scientific conferences between July 2002 and May 2004. DATA EXTRACTION: Data were reviewed to identify any information that might change previous guidelines. Based on panel discussion, guidelines were drafted by a writing committee and discussed by the panel until consensus was reached. DATA SYNTHESIS: Four antiretroviral drugs recently have been made available and have broadened the options for initial and subsequent regimens. New data allow more definitive recommendations for specific drugs or regimens to include or avoid, particularly with regard to initial therapy. Recommendations are rated according to 7 evidence categories, ranging from I (data from prospective randomized clinical trials) to VII (expert opinion of the panel). CONCLUSION: Further insights into the roles of drug toxic effects, drug resistance, and pharmacological interactions have resulted in additional guidance for strategic approaches to antiretroviral management.


Subject(s)
Antiretroviral Therapy, Highly Active/standards , HIV Infections/drug therapy , Adult , Anti-HIV Agents/therapeutic use , CD4 Lymphocyte Count , Humans , Viral Load
20.
Clin Infect Dis ; 37(1): 113-28, 2003 Jul 01.
Article in English | MEDLINE | ID: mdl-12830416

ABSTRACT

New information about the benefits and limitations of testing for resistance to human immunodeficiency virus (HIV) type 1 (HIV-1) drugs has emerged. The International AIDS Society-USA convened a panel of physicians and scientists with expertise in antiretroviral drug management, HIV-1 drug resistance, and patient care to provide updated recommendations for HIV-1 resistance testing. Published data and presentations at scientific conferences, as well as strength of the evidence, were considered. Properly used resistance testing can improve virological outcome among HIV-infected individuals. Resistance testing is recommended in cases of acute or recent HIV infection, for certain patients who have been infected as long as 2 years or more prior to initiating therapy, in cases of antiretroviral failure, and during pregnancy. Limitations of resistance testing remain, and more study is needed to refine optimal use and interpretation.


Subject(s)
Anti-HIV Agents/pharmacology , Drug Resistance, Viral/physiology , HIV-1/drug effects , Adult , Anti-HIV Agents/therapeutic use , Drug Therapy, Combination , Female , HIV Infections/drug therapy , HIV Infections/immunology , HIV-1/physiology , HLA Antigens/immunology , Health Planning Guidelines , Humans , Microbial Sensitivity Tests , Pregnancy , Reverse Transcriptase Inhibitors/pharmacology , Virus Replication/drug effects
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