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HIV Clinical Resource : Antiretroviral Therapy Updates to sections of this guideline are date stamped. As of June 2. 01. Selecting an Initial ART Regimen” is under revision.
Please refer to the April 2. DHHS guideline for the most current information on ART for adults. GUIDELINE UPDATESJune 2.
New York State Department of Health Policy defines eligibility for HIV care and treatment based on infection status, thus making any person with a diagnosis of HIV eligible for care. Read policy announcement. September 2. 01. 5: The recommendation for initiation of treatment was updated to initiate treatment at the time of diagnosis. This recommendation is based on evidence that patients with established HIV infection benefit from ART at all stages of disease and on recent data that demonstrate a dramatic reduction of HIV transmission risk from ART- treated patients (see Section III: When to Initiate ART). Public health guidance currently recommends that all patients living with HIV be treated with ART to reduce transmission of HIV in a strategy commonly known as “treatment as prevention.” This Committee strongly supports the idea of treatment as prevention. I. INTRODUCTIONAntiretroviral therapy (ART) refers to the use of pharmacologic agents that have specific inhibitory effects on HIV replication.
The use of less than three active agents is not recommended for initiating treatment. These agents belong to six distinct classes of drugs: the nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs, Nt. RTIs), the non- nucleoside reverse transcriptase inhibitors (NNRTIs), the protease inhibitors (PIs), the fusion inhibitors (FIs), the CCR5 co- receptor antagonists, and the integrase strand transfer inhibitors (INSTIs). See all commercially available antiretroviral drugs that are FDA- approved for the treatment of HIV/AIDS. II. GOALS, BENEFITS, AND RISKS OF ARTUpdated March 2.
April 2. 01. 5RECOMMENDATIONS: Clinicians should prescribe an ART regimen that is best able to delay disease progression, prolong survival, and maintain quality of life through maximal viral suppression (see Table 1). The clinician should review the benefits and risks of treatment for each individual patient. The maximal suppression of viral replication is generally associated with gradual increases in the CD4 count and clinical stabilization or improvement of HIV- associated symptoms. When maximal suppression is not attainable due to the inability to construct an effective regimen for the patient, partial viral suppression (.
However, incomplete suppression of viral replication may be associated with continued immunologic and clinical deterioration and the evolution of additional resistance mutations. Patients who are unable to adhere strictly to complex medication regimens are those most likely to develop HIV- drug resistance and to face limited future ART options (see Section IV: The Importance of Patient Adherence).
The clinician needs to review the benefits and risks of treatment for each individual patient (see Table 2). Table 2: Benefits and Risks of Antiretroviral Therapy.
The benefits of ART include: The preservation and/or restoration of immune function. Improvement of overall health and the prolongation of life.
The suppression of viral replication. The possible decrease in risk of viral transmission to others (including fetal transmission)The risks of ART include: Adverse effects of the medications on quality of life. Known, and as yet unknown, long- term drug toxicities, including potential fetal toxicity. The development of HIV drug resistance to drugs currently available and possibly to those not yet available, which may limit future treatment optionsback to top. III. WHEN TO INITIATE ARTUpdated September 2.
Table 3: Recommendations for Initiating ART1. ART should be recommended for all patients with a diagnosis of HIV infection. Clinicians should strongly recommend initiation of ART for patients who present with any of the following conditions that increase the urgency of starting ARTa: AIDS- defining condition (AI)Pregnancyb (AI)Symptomaticfrom HIV, including any of the following: HIV- associated neurocognitive disorder (HAND)c (AII)Severe thrombocytopenia (AII)HIV- associated nephropathy (AII)HIV- related malignancies (AII)Chronic hepatitis B or C infectiond,e (AII)Age 5. AII)3. Patients with seronegative partners should be counseled about the reduction of HIV transmission risk when effective ART is initiated; ART is strongly recommended in patients with seronegative partners. Decisions to initiate ART should be individualized (see Section III.
B), particularly for the following populations: Long- term nonprogressorsf (AII)Elite controllersg (AIII)Patients with potential barriers to adherence (AIII)a See Appendix B for evidence and ratings. For recommendations on initiating ART in HIV- infected pregnant women, refer to the DHHS Recommendations for the Use of Antiretroviral Drugs in Pregnant HIV- 1- Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. HAND is currently used to encompass a hierarchy of progressive patterns of central nervous system involvement ranging from asymptomatic neurocognitive impairment (ANI), to minor neurocognitive disorder (MND), to the more severe HIV- associated dementia (HAD) (see Cognitive Disorders and HIV/AIDS). Initial ART regimens for patients with chronic hepatitis B must include NRTIs that are active against hepatitis B (see Hepatitis B Virus guidelines). In co- infected patients with HCV genotype 1 and CD4 counts > 5.
ART until HCV treatment is concluded due to significant interactions between some antiretroviral agents and NS3/4. A protease inhibitors used as part of hepatitis C therapy (see Hepatitis C Virus guidelines). Long- term nonprogressors demonstrate a lack of disease progression, marked by no symptoms and low viral loads in the absence of therapy during long- term follow- up. Most published studies of long- term nonprogressors include 7- 1. Section III. B). g Elite controllers suppress HIV to low but detectable levels (Section III.
B). RECOMMENDATIONS: Evaluation and preparation for ART initiation includes each of the following essential components: Clinicians should refer patients for supportive services as necessary to address modifiable barriers to adherence. An ongoing plan for coordination of care should be established. The patient should make the final decision of whether and when to initiate ART. Together with the dramatic reduction of transmission risk with effective treatment, these data support the initiation of ART regardless of CD4 count in all adequately prepared patients, including patients diagnosed with acute HIV infection (for more discussion see Diagnosis and Management of Acute Infection). Patients in care who are documented long- term nonprogressors or elite controllers are a group that may warrant special consideration (see Section B: Deferring ART). Patients with chronic infection and higher CD4 counts are at low risk for short- term adverse outcomes, allowing time for proper assessment, education, and engagement of the patient in the decision to treat.
In START, a randomized trial initiating ART in treatment- na. ART is now part of the established strategy aimed at reducing HIV transmission and is an essential component of prevention interventions along with risk- reduction counseling, safer- sex practices, and avoidance of needle- sharing.
Although the majority of patients both in New York and worldwide present later in the course of their HIV infection,2. HIV testing to all 1. Key Point: For HIV therapy to be successful over time, the initiation of ART should involve both the selection of the most appropriate regimen and the acceptance of the regimen by the patient, bolstered by education and adherence counseling. All are critical in achieving the goal of durable and complete viral suppression.
Resources. The CEI Line provides primary care providers in New York State the opportunity to consult with clinicians who have experience managing ART. The CEI Line can be reached at 1- 8. The AIDS Institute maintains a voluntary HIV Provider Directory to assist with identification of experienced providers in New York State.
Experienced providers can also be identified through the American Academy of HIV Medicine (AAHIVM) and the HIV Medicine Association (HIVMA). A. Counseling and Education Before Initiating ARTRECOMMENDATIONS: Counseling and education should include the following: Basic education about HIV, CD4 cells, viral load, and resistance (AIII)Available treatment options and potential risks and benefits of therapy (AIII) (see Table 4)The need for strict adherence to avoid the development of viral drug resistance (AII) (see Section IV: The Importance of Patient Adherence)Use of safer- sex practices and avoidance of needle- sharing activity, regardless of viral load, to prevent HIV transmission or superinfection (AIII)Clinicians should involve the patient in the decision- making process regarding initiation of ART. The clinician and patient should discuss the benefits of early ART (see Table 4) and individual factors that may affect the decision to initiate, such as patient readiness or reluctance and adherence barriers. Clinicians should involve the patient in the decision- making process regarding initiation of ART. When clinicians and patients engage in shared decision- making, patients are more likely to choose to initiate ART and to achieve an undetectable viral load. Misconceptions about treatment initiation should be addressed, including the implication that starting ART represents advanced HIV illness.
Initiating ART before symptoms occur allows patients to stay healthier and live longer.