FAQs

What is Rapid Initiation of ART (RIA)?

Rapid Initiation of ART (RIA) refers to starting antiretroviral treatment at the time a person is diagnosis with HIV. Access to RIA is an important intervention, consistent with the concept of universal ART and necessary to our efforts to end the HIV epidemic. We know that a person with a sustained undetectable HIV viral load is healthier and cannot transmit HIV. Offering treatment to persons newly diagnosed with HIV provides a way for an individual to take swifter steps to improve their health, protect their partners, and may help minimize HIV-related stigma.

What is the suggested timeline for RIA?
Why is access to RIA Important now?

Improved health outcomes

Rapid initiation of ART accelerates the time to viral load suppression, prevents HIV transmission and improves viral load suppression compared to standard ART treatments

"Delays in testing, linkage to care, and treatment are major factors that contribute to increase mortality in HIV patients." [1]

Expert recommendations
The NYSDOH Clinical Guidelines, US Department of Health and Human Services (DHHS), World Health Organization, and the International Antiviral Society-USA (IAS-USA) all advise prompt ART initiation regardless of CD4+ T cell count.

RIA benefits the community
Earlier treatment has the potential to reduce new infections

Patients want this option

  • Patients accept the practice of treatment once a disease is diagnosed and RIA is a proactive approach to a life changing diagnosis.
  • Data from clinics in New York State and San Francisco show that over 75% of the patients accepted the option of expedited treatment. These patients achieved viral load suppression more quickly than those started on a “standard treatment” timeline and at the end of one year, patients in the rapid initiation group were more likely to remain engaged in care.

[1] Koenig SP et al. Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial. PLoS Med. 2017; 14(7):e1002357.

What is the evidence base for RIA?

In pilot studies in the United States and in randomized controlled trials in resource-limited settings, rapid ART initiation has been shown to reduce the time to linkage to care and viral load suppression. “The START (“Strategic Timing of Antiretroviral Treatment”) study is a randomized, controlled clinical trial of “immediate” (CD4>500) vs. “deferred” (CD4 ≤ 350) ART, designed to more clearly define the optimal time for HIV- infected individuals to begin antiretroviral therapy.”[2] The study found that the risk of developing serious illness or death was 53% lower in the early treatment group than in the deferred treatment group. Additionally, rates of serious AIDS related events and serious non-AIDS related events were lower in the immediate treatment group than in the deferred treatment group. [3]

Other benefits include:

  • Immediate ART may reduce reservoir size and chronic inflammation
  • ART started later in infection is associated with less robust immune reconstitution
  • Providers who have used rapid initiation protocols report decreased anxiety and increased sense of control among their patients who start ART at the time of diagnosis

Immediate ART protocols have been piloted in various U.S. clinics [4,5,6], and initiating ART at the time of HIV diagnosis has become standard of care in several clinics and jurisdictions, including San Francisco (under the municipal Getting to Zero initiative and New York City (in the NYC Department of Health and Mental Health Sexual Health Clinics). Immediate ART is supported by the International Antiviral Society-USA (IAS-USA) guidelines, which state: “ART should be initiated as soon as possible after diagnosis, including immediately after diagnosis, unless [the] patient is not ready to commit to starting therapy (evidence rating A1a).”

[2] Rosen S et al. Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapID Randomized Controlled Trial. PLoS Med. 2016; 13 (5):e1002015.
[3] Amanyire G, Semitala FC, Namusobya J, et al. Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial. Lancet HIV. 2016; 3 (11):e539-e548.
[4] Pilcher CD, Ospina-Norvell C, Dasgupta A, et al. The Effect of Same-Day Observed Initiation of Antiretroviral Therapy on HIV Viral Load and Treatment Outcomes in a US Public Health Setting. J Acquir Immune Defic Syndr. 2017 Jan 1;74(1):44-51.
[5] Ford N, Migone C, Calmy A, et al. Benefits and risks of rapid initiation of antiretroviral therapy. AIDS. Jan 2, 2018; 32(1):17-23.
[6]Colasanti J, Sumitani J, Mehta CC, et al. Implementation of a Rapid Entry Program Decreases Time to Viral Suppression Among Vulnerable Persons Living with HIV in the Southern United States. Open Forum Infect Dis. 2018 Jun 28;5(6).

When should RIA be offered?

ART should be initiated as soon as possible after diagnosis, including immediately after diagnosis, unless the patient is not ready to commit to starting therapy [8]. A newly diagnosed patient who is interested in immediate treatment can be started on treatment based on a single reactive HIV rapid test result. If available, a second test from a different manufacturer or based on a different rapid test technology will increase provider confidence in the initial result but is not required. If both tests are reactive, it is extremely unlikely that this is a false-positive and the practitioner can provide the patient with that information.
RIA implementation procedures will vary by facility. If agency policy requires laboratory verification before starting treatment, obtain baseline laboratory tests along with a confirmatory HIV 1/2 antigen/antibody assay. Discuss the option of rapid treatment and schedule an intake/medication initiation appointment as soon as the laboratory-based HIV diagnostic test results are available.

[8] Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2018 recommendations of the International Antiviral Society-USA Panel. JAMA. 2018; 320(4):379-396

Is RIA safe?

Yes. The regimens suggested as initial treatment for RIA are included as “preferred” choices in the NYSDOH Clinical Guidelines. Once-daily regimens promote adherence and are more likely to be taken as prescribed. The recommended regimens are equally efficacious, are safe, well-tolerated, and likely to achieve viral suppression even in the setting of limited drug resistance. The only “preferred initial” once daily regimens not suitable for same day initiation contain abacavir.

It is important to emphasize that immediate treatment of ART is safe and can begin to decrease viral load while the results of resistance testing and baseline laboratory results are still pending.

Who is appropriate for RIA?

Individuals with a new, confirmed HIV diagnosis with no known contraindication. Patients may include:

  • Those with a reactive point-of-care (POC) HIV test, or

  • Those with a positive lab result from a lab-based HIV test, or

  • Those who are identified as previously diagnosed and:

    • have never been in care, or
    • are treatment naïve
Are persons who have been out of care eligible for RIA?

Patients re-engaging in care with clear, uncomplicated ART history and low like-hood of resistance may be eligible for RIA - determined on a case-by- case basis.

When is rapid initiation of ART contraindicated?

An HIV specialist should be consulted when immediate treatment might be medically dangerous such as in the setting of:

  • Severe liver or kidney disease
  • Untreated cryptococcal meningitis (defer ART for 5 weeks after the diagnosis of cryptococcal meningitis
  • Other intracranial opportunistic infections (defer ART for 5 weeks after the diagnosis of cryptococcal meningitis)
  • Other intracranial opportunistic infections (defer ART per attending physician’s discretion)
  • Pulmonary Kaposi sarcoma before chemotherapy (usually Doxil) has been started
Who can prescribe ART at the time of diagnosis?

Below clinicians can offer immediate ART to a newly diagnosed patient:

  • Physician
  • Nurse Practitioner
  • Midwife
  • Physician’s Assistant
What is included in an RIA initial visit?

The initial visit is a compressed version of the standard initial HIV primary care visit. [9] The clinician takes the patient’s history and performs an assessment in condensed formats, with goals of:

  • Obtaining enough history to form a decision about whether to start ART and what ARV medications to use
  • Beginning education about HIV, ART (potential benefits of early ART, adherence, etc.), and preventing transmission to others
  • Engaging the patient to increase their comfort level with the provider and clinic staff, increasing the likelihood of retention in care
  • Ensuring required laboratory tests are drawn before treatment is started.
  • Offer an ART Prescription using one of the preferred regimen

[9] Wong.S and Kay, K. Clinical Essentials: HIV testing, Rapid ART, PEP, and Prep. Pacific AIDS Education and Training Centers, National Resource Center; November 2018. Available at http://paetc.org/wp-content/uploads/2018/12/PAETCHIVEssentialsAndQuickClinicalGuides.pdf

Recommended elements for the initial visit

HIV Risk/Prevention History

  • Last negative HIV test
  • PrEP use
  • PEP use
  • Serostatus of partners if known

Medical History

  • Comorbidities (especially renal/liver problems)
  • Medications
  • Drug allergies
  • Review of systems [to alert for the presence of opportunistic infections(OI) or Acute HIV (AHI)]

Initial examination and assessment are done, and baseline laboratory tests drawn before starting ART. It is important to remember that the medication can be started prior to receiving laboratory test results.

What baseline laboratory tests are recommended for those starting immediate Art?

All patients newly diagnosed with HIV should have the following laboratory tests performed on the initial visit:

▪ HIV quantitative viral load
▪ CD4 count
▪ HIV genotype [including protease and reverse transcriptase genes]
▪ Serology for Hepatitis A, B and C
▪ CBC, metabolic panel [including creatinine and LFTs]
▪ Syphilis serology
▪ Chlamydia and gonorrhea, including appropriate extragenital sites
▪ Pregnancy test

Patient Follow-up

Patients started on ART at the first clinic visit need additional education and extra supports in the days and weeks that follow. Models used in NYS clinical settings include phone calls and/or texts in the period immediately following ART initiation and schedule a return clinical visit within the next 7 days.

  • Schedule a phone check-in with a social worker, nurse or clinician within the next two days to answer questions and assess for any issues with medication. Because they have recently been diagnosed with HIV and started on ART with little or no advance preparation, they will need additional HIV-related education, information regarding the importance of medication adherence, counseling about preventing HIV transmission, and encouragement about living healthy lives with HIV.
  • The first follow-up visit should include medical, nursing and social work assessments, adherence counseling, and partner services information. Review baseline laboratory results including genotype resistance testing and adjust initial regimen if necessary.
  • Complete NYSDOH Patient Reporting Form (PRF).
What support and ongoing assessments are required for patients on immediate ART?

Newly diagnosed patients need much of the same support that patients treated under standard protocols need, including support from pharmacists, mental health professionals, substance abuse counselors, and social workers.

Regional HIV service organizations are located across NYS and can provide unique and vital navigation and support services to individuals who are newly aware that they are living with HIV.

HIV program staff are knowledgeable about community resources and can help navigate the patient through barriers such as medication adherence or adherence to appointments, transportation, insurance, and then link patient to appropriate support services.

Agency social workers and peers help patients deal with issues such as disclosure and other stresses related to learning of their diagnosis.

What assistance is available to ensure immediate access to recommended ARVs?
  • Patients enrolled in fee for service Medicaid or managed Medicaid at the time of diagnoses can access immediate ART.
  • Patients with commercial insurance should be able to access immediate ART. They may need pharmacy coupons or enrollment in pharma-sponsored patient assistance programs, to help with copays or share of cost, especially before their deductible is exhausted.
  • The AIDS Drug Assistance Program (ADAP) will cover office fees for services provided by ADAP enrolled clinicians and laboratories for up to 30 days prior to enrollment. However, these patients may require pharmacy coupons or enrollment in pharma-sponsored patient assistance programs, to cover costs related to initial medications.
  • Manufacturers of medications included in the preferred once daily initial regimens have patient assistant programs that provide free medication or copay assistance to persons newly diagnosed with HIV. These benefits can be immediately activated by a provider through the manufacturer’s website or by telephone.
Should providers wait for genotype results before ART initiation?

For treatment naïve persons, no. The goal of RIA is to remove barriers to ART initiation. The regimens recommended for initial treatment should provide a high barrier to resistance while the results of the screening genotype are pending. Therefore, providers should not wait for genotype results before starting ART but should instead modify the regime based if indicated by the genotype results.

Should providers wait for psychosocial stabilization before ART initiation?

Patients who want to start treatment immediately should have that choice when possible. While patients with untreated mental health, active substance use, immigration issues and/or marginal housing may face barriers to successful adherence and linkage, they deserve the highest standard of HIV care, which includes the option of RIA.

Despite individual barriers, most patients can achieve viral load suppression by taking recommended medication, in conjunction with appropriate counseling and contingency management plans that address immediate issues. Linkage to support services for help with significant issues will improve long term engagement.

Are there Drug – Drug Interactions to consider with these two choices?

The NYSDOH HIV Guideline table “Select Drug-Drug Interactions to Discuss before Initiating ART” includes a comprehensive table of Drug-Drug interactions. The following interactions only pertain to a component in the regimens listed above.

Cobicistat (COBI) have interactions with:

  • Inhaled steroids and statins may require alternative choices or dose adjustments. Consult the package inserts for drug-drug interactions between specific statins and ARVs.
  • Factor Xa inhibitors: Aixiban – requires dose adjustment. Dabigatran – avoid if CrCl <50 mL/min. Rivaroxaban: avoid use.
  • Platelet inhibitors: Clopidogrel and Ticagrelor: Avoid use; Prasugrel: No adjustment needed
Should a patient wait to start ART until a long-term relationship with an HIV provider has been established?

In almost all cases, patients should NOT wait to start ART until a relationship with an HIV provider has been established. Data from New York City, San Francisco and other rapid treatment sites show that this process can take weeks to months, delaying treatment. Rapid initiation protocols allow for the simultaneous initiation of ART and establishment of a patient-provider relationship.

What does RIA mean for the patient?
  • The offer of treatment on the day of diagnosis has been shown to improve adherence and retention in care. Immediate treatment is standard care with other treatable conditions and reinforces the importance of viral load suppression and medication adherence. Clinical experience demonstrates that: Readily available treatment reduces anxiety and uncertainty associated with the extended waiting time for an appointment, baseline evaluations and tests prior to routine treatment.
  • Even as patients adjust to their diagnosis, starting treatment can represent an active, responsible decision to improve health and prevent HIV transmission.
  • Taking ART as prescribed can help the patient achieve an undetectable viral load faster than ever and minimizes the risk of sexually transmitting HIV to their partners.
  • Patients offered treatment at time of diagnosis rate their patient experience positively.
What once-daily regimens are recommended for rapid initiation of ART?

The NYSDOH Clinical Guidelines include these once daily regimens in the group of “Preferred Initial ART Regimens for Non-pregnant Adults” . All are appropriate for immediate initiation. The full chapter “Selecting an Initial ART Regimen” includes several equally efficacious regimens as well as dose adjustments for renal or hepatic impairment.

Regimens

REGIMEN 1: Tenofovir alafenamide/emtricitabine/bictegravir
(TAF 25mg/FTC/BIC; Biktarvy)

  • Initiate only in patients with CrCl ≥30 mL/min.
  • Contains 25 mg of TAF, unboosted.
  • Take magnesium- or aluminum-containing antacids 2 hours before or 6 hours after BIC; calcium-containing antacids or iron supplements may be taken simultaneously if taken with food.

REGIMEN 2: Tenofovir alafenamide/ emtricitabine and dolutegravir
(TAF 25 mg/FTC & DTG [Descovy & Tivicay])

  • Initiate only in patients with CrCl ≥30 mL/min.
  • Documented DTG resistance after initiation in treatment-naive patients is rare.
  • Contains 25 mg of TAF, unboosted.
  • Take magnesium- or aluminum-containing antacids 2 hours before or 6 hours after DTG; calcium-containing antacids or iron supplements may be taken simultaneously if taken with food.

REGIMEN 3: Tenofovir alafenamide/ emtricitabine and raltegravir
(TAF 25 mg/FTC & RAL HD [Descovy & Isentress HD])

  • Initiate only in patients with CrCl ≥30 mL/min.
  • To date, no clinical trials have been conducted with TAF and RAL; data are based on bioequivalence pharmacokinetic studies.
  • Contains 25 mg of TAF, unboosted.
  • Administer as TAF/FTC once daily and RAL HD 1200 mg once daily, dosed as two 600 mg HD tablets.
  • Magnesium- or aluminum-containing antacids are contraindicated; co-administration of calcium-containing antacids is not recommended with RAL HD.

current as of January 2019

What are the treatment options for newly diagnosed patients recently on PEP or PrEP?

Integrating early treatment for patients who have a reactive HIV test can be clinically straightforward, with minimal risks and substantial benefits. While awaiting results from resistance tests, the DHHS recommends using a regimen consisting of an integrase inhibitor (dolutegravir or bictegravir) + boosted darunavir + TAF/FTC (or TDF/FTC or TDF/3TC) in patients who acquire the infection before or shortly after the use of prophylactic ART.

What regimens are NOT recommended for immediate ART?

Abacavir-containing regimens are not recommended for immediate ART, since ART is begun while HLA B5701 testing is pending.