Medical Care Criteria Committee, April 2015
Antiretroviral 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, NtRTIs), 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.
Goals, Benefits, and Risks of ART
Goals of ART:
- Maximal and durable suppression of viral replication (measured by viral load assays)
- Restoration and/or preservation of immune function
- Reduced HIV-related morbidity and mortality
- Improved quality of life
- Limitation of the likelihood of viral resistance to preserve future treatment option
In typical clinical practice, durable suppression of viral replication to undetectable levels may be achieved in approximately 80% of cases. 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 (≥0.5 log reduction, or 3-fold, from baseline viral load value) and stable CD4 counts are reasonable alternative goals. 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. The clinician needs to review the benefits and risks of treatment for each individual patient (see below).
Benefits of ART:
- 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)
Risks of ART:
- 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 options
Appendix A: Risk of Progression to AIDS-Defining Illness
|CD4 ≤200 Plasma Viral Load (copies/mL) [a]||% AIDS (AIDS-Defining Complication) [b]|
|bDNA||RT-PCR||n||3 years||6 years||9 years|
|CD4 201-350 Plasma Viral Load (copies/mL) [d]||% AIDS (AIDS-Defining Complication) [d]|
|bDNA||RT-PCR||n||3 years||6 years||9 years|
|CD4 >350 Plasma Viral Load (copies/mL)||% AIDS (AIDS-Defining Complication) [b]|
|bDNA||RT-PCR||n||3 years||6 years||9 years|
Note: Adapted from the DHHS Guidelines for the Use of Antiretroviral Agents in HIV-infected Adults and Adolescents (2006).
Appendix B: Prognosis According to CD4 Cell Count and Viral Load in the Pre-HAART and HAART Eras
Click to enlarge: Reprinted with permission from Elsevier (The Lancet, 2002, Vol. 360, 19-29).
Selecting an Initial ART Regimen
Editor’s Note: This section is currently under revision. Please refer to the DHHS guideline What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient for the most current information on preferred initial ART regimens, alternative initial ART regimens, considerations for prescribing initial ART in the setting of specific clinical scenarios, and advantages and disadvantages of antiretroviral components recommended as initial ART.
When to Initiate ART
Preliminary results from the START trial  and increasingly strong cohort data show that untreated HIV infection leads to increased morbidity and mortality from both HIV-related and non-HIV-related conditions, even at high CD4 counts. 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 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-naïve patients with CD4 counts >500 cells/mm3 versus waiting for a decrease to ≤350 cells/mm3 before initiation showed a 53% reduction in serious illness and death in the early ART group . Data from NA-ACCORD, a large observational cohort study, showed that both morbidity and mortality were improved by initiation of ART in patients with CD4 counts in the high or even normal range . A significantly decreased risk of death was observed in patients who initiated therapy at CD4 counts >500 cells/mm3 compared to those who deferred to <500 cells/mm3, as well as in the cohort who initiated ART in the 350-500 cells/mm3 range compared with those deferring to <350 cells/mm3 . Although other cohort studies demonstrated only a minimal survival advantage  or no survival advantage among those starting ART at the highest CD4 counts, they did confirm the benefits of initiating ART at levels ≤500 cells/mm3 [4-6]. Another showed an approximately 33% reduction in the risk of death from end-stage liver disease, non-AIDS infections, and non-AIDS-defining cancers with each 100 cells/mm3 increase in CD4 count . A randomized study of early versus deferred therapy in patients with CD4 counts in the 350-550 cells/mm3 range showed no mortality benefit ; however, this study has significant limitations, most notably a relatively brief follow-up period.
Accumulating evidence suggests that patients who initiate ART earlier or spend less cumulative time with detectable plasma viremia are less likely to suffer certain complications, such as cardiovascular disease [7,9-12], neurocognitive dysfunction [13-16], decreased risk of severe bacterial infections , and some non-HIV-related malignancies [18-21]. Cohort data also demonstrate that although older patients are likely to achieve virologic suppression, they are less likely to achieve an immunologic response, as measured by an increase of CD4 count by 100 cells/mm3, and that patients >55 years old may be at higher clinical risk even after starting therapy . The poor immunologic recovery seen in older patients is associated with higher morbidity and mortality, particularly cardiovascular events . In one study, men ≥50 years of age who initiated ART with CD4 counts in the 351-500 cells/mm3 range were able to achieve similar immunologic responses as younger men who initiated at lower CD4 counts .
Studies have shown that, for HIV-infected pregnant women, the administration of ART during pregnancy and/or intrapartum significantly reduces the risk of mother-to-child transmission (MTCT) of HIV [25,26]. In addition, a large study showed a 96% reduction in transmission between serodiscordant heterosexual couples when the positive partner was receiving ART , adding to the body of evidence that lower viral load reduces transmission risk. 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 [27-29], ongoing efforts to offer universal HIV testing to all patients over age 13 may begin to identify patients earlier in their disease who can benefit from immediate treatment.
|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 1-866-637-2342 or 1-585-273-2793.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).|
Counseling and Education Before Initiating ART
Discussion of ART should occur at the start of care for all HIV-infected patients, regardless of CD4 count. The clinician and patient should discuss the benefits of early ART (see below) 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.
|Patients who do not have health insurance may qualify for Medicaid or the NYSDOH HIV Uninsured Care Program, which provides access to free health care (HIV drugs, primary care, home care, and the ADAP Plus Insurance Continuation Program, or APIC) for residents who are HIV-infected but uninsured or underinsured. The program is open Monday-Friday, 8:00AM-5:00PM and can be reached: in state 1-800-542-2437; out-of-state 1-518-459-1641; TDD 1-518-459-0121.If eligible, patients may also consider treatment options through enrollment in clinical trials. A resource that may help with this process is the AIDS Clinical Trials Information Service (1-800-TRIALS-A).|
The risks and benefits of early ART to discuss with patients when making the decision of whether and when to initiate ART are outlined below.
BENEFITS of early ART in asymptomatic patients:
(early therapy = initiation at CD4 counts >500 cells/mm3)
- Earlier treatment reduces both HIV-related and non-HIV-related morbidity and mortality [1,2,7,10,18,32-35]
- Delay or prevention of immune system compromise 
- Possible lower risk of antiretroviral resistance 
- Decreased risk of sexual transmission of HIV [8,38-40] (The risk of viral transmission still exists even when the plasma viral load is undetectable; ART is not a substitute for primary HIV prevention measures, such as avoiding needle sharing, practicing safer sex .)
- Decreased risk of several severe bacterial infections 
DISADVANTAGES of early ART in asymptomatic patients:
- Potential drug-related reduction in quality of life in otherwise asymptomatic individuals [41-43]
- Possibility of greater cumulative side effects from ART 
- Possibility for earlier development of drug resistance and limitation in future  antiretroviral options if adherence and viral suppression are suboptimal
- Possibility for earlier onset of treatment fatigue
- Higher prescription drug costs for the individual
Potential Barriers to Adherence
Although the current first-line regimens used for ART are much easier to tolerate with fewer side effects than earlier combinations, they are not free of side effects. Their use requires a lifelong commitment from the patient. Patients who prefer not to take medication, or who do not understand the significance of skipping doses, are at high risk for poor adherence and subsequent viral resistance. Except when initiation of treatment is clinically urgent, more than one visit before initiating ART is advisable to ensure adequate understanding of the importance of adherence and to address potential barriers or impediments to therapy. These may include but are not limited to active alcohol or drug use; lack of insurance, transportation, or housing; depression; mistrust of medical providers; or a poor social support system. These barriers should not necessarily preclude initiation of ART; some may not be completely modifiable before starting therapy and will require ongoing attention and use of supportive services throughout the course of therapy.
Patients who are at high risk for poor adherence may benefit if initiation of ART is temporarily deferred while further patient education efforts are undertaken. In these patients, the risk of viral resistance and eventual treatment failure may outweigh any clinical benefit from earlier treatment before strict adherence can be expected . These patients should remain under particularly close observation for clinical and laboratory signs of disease progression . ART should be initiated as soon as the patient seems prepared to adhere to a treatment regimen. In patients with advanced AIDS, it is appropriate to initiate ART even if some barriers to adherence are present. In these cases, referrals to specialized adherence programs should be made for intensified adherence support.
Long-term Nonprogressors and Elite Controllers
- 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 7-10 years of follow-up. 
- Elite controllers suppress HIV to low but detectable levels (<50-75 copies/mL) for many years. 
The role of early ART initiation in long-term nonprogressors or elite controllers is unclear. At this time, there are not enough data to recommend for or against initiation of ART in long-term nonprogressors and elite controllers. Close monitoring of CD4 count and viral load level may be an acceptable approach. Declines in CD4 count should prompt consideration of initiation of ART. Elite controllers have demonstrated CD4 cell increases after initiation of ART . Another study found higher rates of hospitalizations in elite controllers compared to treatment suppressed patients, particularly for cardiovascular and psychiatric conditions ; however, there were important limitations in this analysis and it does not provide definitive evidence in favor of treating this rare population based on current information . The clinician and patient should discuss the current data on the risks and benefits of early ART as well as individual factors that may affect the decision to initiate, such as patient readiness and reluctance, adherence barriers, CD4 cell count and viral load, comorbidities, age, and partner serodiscordance. If treatment is delayed, clinicians should counsel patients about the risk of HIV transmission to partners.
In a randomized study, patients who initiated ART at a median of 12 days from start of OI therapy had better outcomes, as measured by disease progression and death, without an increase in adverse events, compared to those who initiated ART at a median of 45 days from presentation . Although this study excluded patients with active TB, three randomized controlled trials in patients newly diagnosed with HIV and pulmonary TB have demonstrated a significant mortality benefit when ART was initiated during the first 2 months of starting anti-TB therapy and a further benefit when those who were severely immunocompromised initiated therapy in the first 2 weeks [53-55]. Although antiretroviral agents and anti-TB medications can have overlapping toxicities, ART should be initiated within the first 8 to 12 weeks of starting anti-TB therapy. Patients with CD4 counts <50 cells/mm3 should receive ART within the first 2 weeks of initiating anti-TB therapy.
Tuberculous meningitis and cryptococcal meningitis are exceptions; there are data showing that early initiation of ART increases adverse events and mortality in this setting [56-60]. Close attention should be paid to possible drug-drug interactions between OI therapy and ART. In some cases, determining the optimal timing for initiating ART in patients with OIs can be complex and may require consultation with a clinician with experience in management of ART in this context.
After initiating ART, clinicians need to be alert to the possibility of immune reconstitution syndromes as CD4 cell counts are restored (see Immune Reconstitution Inflammatory Syndrome).
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Medical Care Criteria Committee, September 2015
|ALL RECOMMENDATIONS: INITIATING ART|
Goals, Benefits, and Risks
When to Initiate
Counseling and Education before ART Initiation
Initiating ART Following Acute OIs