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NEW HIV Guidelines Recommends HAART When CD4 >500 (BIII: moderate recommendation based on expert opinion) & Aging UPDATE....
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· Antiretroviral therapy (ART) is recommended for all HIV-infected individuals. The strength of this recommendation varies on the basis of pretreatment CD4 cell count:
· CD4 count <350 cells/mm3 (AI)
· CD4 count 350 to 500 cells/mm3 (AII)
· CD4 count >500 cells/mm3 (BIII)
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = data from randomized controlled trials; II = data from well-designed nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = expert opinion
"The recommendation to initiate therapy at CD4 count >500 cells/mm3 (BIII) is based on growing awareness that untreated HIV infection or uncontrolled viremia may be associated with development of many non-AIDS-defining diseases, including cardiovascular disease (CVD), kidney disease, liver disease, neurologic complications, and malignancy"
"The strength of Panel recommendations depends on disease stage. Randomized controlled trials provide definitive evidence supporting the benefit of ART in patients with CD4 counts ≤350 cells/mm3. Results from multiple observational cohort studies demonstrate benefits of ART in reducing AIDS- and non-AIDS-associated morbidity and mortality in patients with CD4 counts ranging from 350 to 500 cells/mm3. The Panel therefore recommends ART for patients with CD4 counts ≤500 cells/mm3 (AI for CD4 count <350 cells/mm3 and AII for CD4 count 350 to 500 cells/mm3)."
"Tempering the enthusiasm to treat all patients regardless of CD4 count is the absence of randomized data that definitively demonstrate a clear benefit of ART in patients with CD4 count >500 cells/mm3 and mixed results on the benefits of early ART from observational cohort studies. In addition, potential risks of short- or long-term drug-related complications and nonadherence to long-term therapy in asymptomatic patients may offset possible benefits of earlier initiation of therapy. When resources are not available to initiate ART in all patients, treatment should be prioritized for patients with the lowest CD4 counts and those with the following clinical conditions: pregnancy, history of an AIDS-defining illness, HIV-associated nephropathy (HIVAN), or HIV/hepatitis B virus (HBV) coinfection."
Antiretroviral therapy (ART) is recommended in patients >50 years of age, regardless of CD4 cell count (BIII), because the risk of non-AIDS related complications may increase and the immunologic response to ART may be reduced in older HIV-infected patients.
·ART-associated adverse events may occur more frequently in older HIV-infected adults than in younger HIV-infected individuals. Therefore, the bone, kidney, metabolic, cardiovascular, and liver health of older HIV-infected adults should be monitored closely.
HIV infection may increase the risk of many major health conditions experienced by aging adults and possibly accelerate the aging process----"OLDER PATIENTS: IMMEDIATE HAART RECOMMENDED: Antiretroviral therapy (ART) is recommended in patients >50 years of age, regardless of CD4 cell count (BIII: based on expert opinion, moderate recommendation), because the risk of non-AIDS related complications may increase and the immunologic response to ART may be reduced in older HIV-infected patients. ART-associated adverse events may occur more frequently in older HIV-infected adults than in younger HIV-infected individuals. Therefore, the bone, kidney, metabolic, cardiovascular, and liver health of older HIV-infected adults should be monitored closely. HIV experts and primary care providers should work together to optimize the medical care of older HIV-infected patients with complex comorbidities ".....HIV and the Older Patient
"Non-AIDS HIV-Related Complications and other Comorbidities:
With the reduction in AIDS-related morbidity and mortality observed with effective use of ART, non-AIDS conditions constitute an increasing proportion of serious illnesses in ART-treated HIV-infected populations [22-24]. Heart disease and cancer are the leading causes of death in older Americans [25]. Similarly, for HIV-infected patients on ART, non-AIDS events such as heart disease, liver disease, and cancer have emerged as major causes of morbidity and mortality. Neurocognitive impairment, already a major health problem in aging patients, may be exacerbated by the effect of HIV infection on the brain [26]. That the presence of multiple non-AIDS comorbidities coupled with the immunologic effects of HIV infection could add to the disease burden of an aging HIV-infected person is a concern [27-29]. At present, primary care recommendations are the same for HIV-infected and HIV-uninfected adults and focus on identifying and managing risks of conditions such as heart, liver, and renal disease; cancer; and bone demineralization [30-32]."
"outpatient clinics providing HIV care in the United States share the same financial problems as other chronic disease and primary care clinics and that reimbursement for care is not sufficient to maintain care at a sustainable level [36]. Continued involvement of HIV experts in the care of older HIV-infected patients is warranted. However, given that the current shortage of primary care providers and geriatricians is projected to continue, current HIV providers will need to adapt to the shifting need for expertise in geriatrics through continuing education and ongoing assessment of the evolving health needs of aging HIV-infected patients [37].The aging of the HIV-infected population also signals a need for more information on long-term safety and efficacy of ARV drugs in older patients."
"The primary goal of antiretroviral therapy (ART) is to reduce HIV-associated morbidity and mortality. This goal is best accomplished by using effective ART to maximally inhibit HIV replication, as defined by achieving and maintaining plasma HIV RNA (viral load) below levels detectable by commercially available assays. Durable viral suppression improves immune function and quality of life, lowers the risk of both AIDS-defining and non-AIDS-defining complications, and prolongs life. Based on emerging evidence, additional benefits of ART include a reduction in HIV-associated inflammation and possibly its associated complications.
The recommendation to initiate therapy at CD4 count >500 cells/mm3 (BIII) is based on growing awareness that untreated HIV infection or uncontrolled viremia may be associated with development of many non-AIDS-defining diseases, including cardiovascular disease (CVD), kidney disease, liver disease, neurologic complications, and malignancy; availability of ART regimens that are more effective, more convenient, and better tolerated than earlier ART combinations no longer widely used; and evidence from one observational cohort study that showed survival benefit in patients who started ART when their CD4 counts were >500 cells/mm3.
Initiating Antiretroviral Therapy in Treatment-Naive Patients
The NA-ACCORD study also observed patients who started ART at CD4 counts >500 cells/mm3 or after CD4 counts dropped below this threshold. The adjusted mortality rates were significantly higher in the 6,935 patients who deferred therapy until their CD4 counts fell to <500 cells/mm3 than in the 2,200 patients who started therapy at CD4 count >500 cells/mm3 (risk ratio: 1.94, 95% CI: 1.37-2.79) [11]. Although large and generally representative of the HIV-infected patients in care in the United States, the study has several limitations, including the small number of deaths and the potential for unmeasured confounders that might have influenced outcomes independent of ART.....In contrast, results from 2 cohort studies did not identify a benefit of earlier initiation of therapy in reducing AIDS progression or death."
"Tempering the enthusiasm to treat all patients regardless of CD4 count is the absence of randomized data that definitively demonstrate a clear benefit of ART in patients with CD4 count >500 cells/mm3 and mixed results on the benefits of early ART from observational cohort studies. In addition, potential risks of short- or long-term drug-related complications and nonadherence to long-term therapy in asymptomatic patients may offset possible benefits of earlier initiation of therapy. When resources are not available to initiate ART in all patients, treatment should be prioritized for patients with the lowest CD4 counts and those with the following clinical conditions: pregnancy, history of an AIDS-defining illness, HIV-associated nephropathy (HIVAN), or HIV/hepatitis B virus (HBV) coinfection.
The decision to initiate ART should always include consideration of other conditions and considerations listed in the Panel's boxed recommendations, the willingness and readiness of the patient to initiate therapy, and the availability of resources. The known benefits and limitations of ART are discussed below."
The Adult and Adolescent HIV Guidelines Panel welcomes feedback on the latest revisions to the adult and adolescent treatment guidelines.
The Panel also invites feedback on the new process and format for release of the guidelines. Please send your comments with the subject line "Adult and Adolescent Guidelines Comments" to ContactUs@aidsinfo.nih.gov by April 10 , 2012.
http://www.aidsinfo.nih.gov/guidelines
Currrent Guidelines
Adult and Adolescent Treatment Guidelines
· Guideline, Web Version HTML
· Panel Roster PDF (16kb)
· How to Cite HTML
· Slide Sets HTML
· Financial Disclosures PDF (75.3 KB)
· Patient Education Materials HTML
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
What's New in the Guidelines?
(Last updated:3/27/2012; last reviewed:3/27/2012)
· Print Section PDF (440 Kb)
Revisions to the October 14, 2011, version of the guidelines include both new sections and key updates to existing sections. The additions and updates, which are highlighted throughout the guidelines, are summarized below.
New Sections
The following new sections have been added to the guidelines.
HIV and the Older Patient
Effective antiretroviral therapy (ART) has led to greater longevity in HIV-infected individuals resulting in an increasing number of older individuals living with HIV infection. Compared with younger HIV-infected patients, older patients may have more comorbidities, which can complicate treatments of HIV and other diseases. This section focuses on HIV diagnosis and treatment considerations in the older HIV-infected patient.
Antiretroviral Drug Cost Table (Appendix C)
This new table lists the monthly average wholesale price (AWP) for U.S. Food and Drug Administration (FDA)-approved brand and generic antiretroviral (ARV) drugs, including fixed-dose combination products. (The AWP listed for an ARV may not represent the pharmacy acquisition price or the price paid by consumers for that drug.)
Key Updates to Existing Sections
Following are key updates to existing sections of the guidelines.
Initiating Antiretroviral Therapy in Treatment-Naive Patients
The Panel updated its recommendations on initiation of ART in treatment-naive patients. The changes are primarily based on increasing evidence showing the harmful impact of ongoing HIV replication on AIDS and non-AIDS disease progression. In addition, the updated recommendations reflect emerging data showing the benefit of effective ART in preventing secondary transmission of HIV. The updated section includes more in-depth discussion on the rationale for these recommendations and on the risks and benefits of long-term ART.
The Panel's recommendations are listed below.
· ART is recommended for all HIV-infected individuals. The strength of this recommendationa varies on the basis of pretreatment CD4 cell count:
o CD4 count <350 cells/mm3 (AI)
o CD4 count 350 to 500 cells/mm3 (AII)
o CD4 count >500 cells/mm3 (BIII)
· Regardless of CD4 count, initiation of ART is strongly recommended for individuals with the following conditions:
o Pregnancy (AI) (see perinatal guidelines for more detailed discussion)
o History of an AIDS-defining illness (AI)
o HIV-associated nephropathy (HIVAN) (AII)
o HIV/hepatitis B virus (HBV) coinfection (AII)
· Effective ART also has been shown to prevent transmission of HIV from an infected individual to a sexual partner. Therefore, ART should be offered to patients who are at risk of transmitting HIV to sexual partners (AI [heterosexuals] or AIII [other transmission risk groups]).
· Patients starting ART should be willing and able to commit to treatment and should understand the benefits and risks of therapy and the importance of adherence (AIII). Patients may choose to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy on the basis of clinical and/or psychosocial factors.
HIV-Infected Women
This revised section includes an expanded discussion on the use of hormonal contraception in HIV-infected women. The discussion focuses on drug-drug interactions between combined oral contraceptives and ARV drugs as well as on recent data showing a possible association between hormonal contraceptive use and acquisition or transmission of HIV.
HIV/Hepatitis C Coinfection
Updates to this section focus on the newly approved HCV NS3/4A protease inhibitors (PIs) boceprevir and telaprevir, the known interactions between these drugs and ART, and interim results from current ongoing research in HIV/HCV coinfected patients. The updated section includes preliminary recommendations on coadministration of the HCV NS3/4A drugs and ART.
Mycobacterium Tuberculosis Disease with HIV Coinfection
This update provides recommendations for timing of initiation of ART in HIV-infected patients who have been diagnosed with tuberculosis (TB) and are not receiving ART. The recommendations are based on results from randomized controlled trials showing survival benefits (1) when ART was initiated during rather than after TB treatment and (2) when ART was started within 2 weeks of TB treatment in patients with pretreatment CD4 count <50 cells/mm3. The updated section provides more in-depth discussions on the evidence and rationale supporting the recommendations.
The Panel's recommendations are as follows:
· For patients with CD4 counts <50 cells/mm3, ART should be initiated within 2 weeks of starting TB treatment (AI).
· For patients with CD4 counts >50 cells/mm3 with clinical disease of major severity as indicated by clinical evaluation (including low Karnofsky score, low body mass index [BMI], low hemoglobin, low albumin, organ system dysfunction, or extent of disease), the Panel recommends initiation of ART within 2 to 4 weeks of starting TB treatment (BI for CD4 count 50-200 cells/mm3 and BIII for CD4 count >200 cells/mm3).
· For other patients with CD4 counts >50 cells/mm3, ART can be delayed beyond 2 to 4 weeks but should be initiated by 8 to 12 weeks of TB therapy (AI for CD4 count 50-500 cells/mm3; BIII for CD4 count >500 cells/mm3).
Drug Interaction Tables (Tables 14-16b)
These tables are updated with recent data on pharmacokinetic (PK) interactions between ARV drugs and other drugs commonly prescribed for HIV-infected patients and the Panel's recommendations on coadministration of these drugs. The key updates include:
· Change in recommendation on dosing of rifabutin with HIV PIs
· New recommendation to not use HIV PIs and non-nucleoside reverse transcriptase inhibitors (NNRTIs) with rifapentine
· Addition of information on interactions of boceprevir and telaprevir with different ARV drugs and related recommendations
· Update of interactions between different ritonavir-boosted PI and HMG-CoA reductase inhibitors.
Prevention of Secondary HIV Transmission
This section is updated to discuss the role of effective ART in preventing HIV transmission. The updated section also indicates evidence-based interventions available to assist providers with HIV risk behavior identification and counseling.
Additional Updates
Minor revisions have also been made to the following sections:
· Treatment Goals
· What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient (new information regarding adverse effects of raltegravir)
· HIV and Illicit Drug Users (new drug interaction added to Table 11 included in the section)
· Adherence to Antiretroviral Therapy
· Adverse Effects of Antiretroviral Agents (and accompanying Table 13)
· Drug Characteristics Tables (Appendix B)
a Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = data from randomized controlled trials; II = data from well-designed nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = expert opinion
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