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HIV Infection: Laboratory Testing for Diagnosis and Management

HIV Infection: Laboratory Testing for Diagnosis and Management

Test Guide

HIV Infection

Laboratory Testing for Diagnosis and Management

 

Laboratory testing plays a central role in the spectrum of clinical care for patients with human immunodeficiency virus (HIV) infection. This Test Guide provides an overview of the use of laboratory tests in the screening, diagnosis, and management of HIV infection. It also provides an Appendix that lists antiretroviral drugs used to treat HIV infection.

The material provided herein is for informational purposes. Treating physicians should base treatment or diagnostic decisions on their education, learning, and experience and the clinical assessment of the patient.

Screening and Diagnosis

The Centers for Disease Control and Prevention (CDC) recommends HIV screening for all adolescents and adults between the ages of 13 and 64 years.1 Annual screening is recommended for those with risk factors.1 Screening is also recommended for all pregnant women.1 Tests offered by Quest Diagnostics for screening and diagnosis can be found in Table 1.

Fourth-Generation Testing Algorithm

Newer screening tests that can detect HIV infection substantially earlier than Western blots have created a need for an algorithm with supplemental testing that is more sensitive for acute infection.2 The CDC has proposed an HIV testing algorithm designed to 1) detect acute infections more often; 2) reduce the frequency of indeterminate results on supplemental testing; and 3) differentiate HIV-1 and HIV-2 antibodies.3,4 This algorithm has been reported to have high sensitivity (>99.7%) and specificity (100%)2,3 and has been adopted by the Clinical Laboratory Standards Institute (CLSI).5

HIV Antibodies and p24 Antigen

The fourth-generation testing algorithm begins with a screening test for HIV-1/HIV-2. The screening test of choice is a fourth-generation combination assay that detects not only HIV IgM and IgG antibodies, but also HIV p24 antigen. HIV p24 antigen becomes detectable before seroconversion but rapidly disappears thereafter. Thus, the antigen component allows detection of infection during the pre-seroconversion window period, while the antibody component allows detection after seroconversion. Reports suggest that fourth-generation assays can detect acute infection a median of 5 to 7 days before third-generation antibody assays,5-7 although this interval can range from roughly 0 to 20 days. This type of antigen/antibody combination assay has >99.7% sensitivity and >99.3% specificity for HIV infection and identifies most (>80%) acute infections that would otherwise require nucleic acid testing for detection.8,9 As with third-generation assays, reactive screening results require confirmation with a supplemental test.

HIV-1/HIV-2 antibody differentiation assays tend to detect antibodies earlier than Western blots2,10 and are the recommended supplemental test in the fourth-generation algorithm.5 These immunoassays not only detect HIV-1 and HIV-2 antibodies but can also differentiate between them. This can have important treatment implications, as HIV-2 does not respond to some antiretroviral agents. Results are interpreted as reactive for HIV-1, reactive for HIV-2, reactive for HIV (nondifferentiated), or nonreactive. A reactive result confirms the presence of HIV-1 and/or HIV-2 antibodies, whereas nonreactive (or indeterminate) results prompt confirmation by HIV-1 RNA testing.5

HIV-1 RNA

HIV-1 RNA can be detected earlier than HIV antibodies and p24 antigen: as soon as 6 to 12 days after exposure and approximately 12 days before an HIV antibody test and 7 days before a p24 antigen test becomes positive.6 Ultrasensitive nucleic acid amplification-based tests such as the HIV-1 qualitative transcription-mediated amplification (TMA) assay (sensitive to 30 copies/mL) are thus useful for detecting suspected infection soon after exposure. Positive HIV-1 RNA results in the absence of detectable antibodies indicate acute infection; negative results are consistent with absence of HIV-1 infection. A negative HIV-1 RNA test may be followed with an HIV-2 DNA/RNA test if clinically warranted. When nucleic acid testing is used to diagnose acute infection, subsequent seroconversion should be documented.5

Infection in Newborns

HIV-1 RNA testing is also useful for detecting HIV-1 infection in high-risk infants (eg, those born to mothers with HIV infection).11 Guidelines recommend virologic (RNA or DNA) testing of perinatally-exposed, nonbreastfed infants at 1 to 2 months of age unless they are receiving antiretroviral prophylaxis. If receiving prophylaxis, infants should be tested 2 to 4 weeks after discontinuation.11 HIV-infected women who are breastfeeding should be counseled to stop. The infant should be tested immediately and at 4 to 6 weeks, 3 months, and 6 months after breastfeeding is discontinued.11

Antibody -based testing is not appropriate in high-risk infants younger than 18-24 months, as maternal antibodies can cross the placenta and be detected in the infant for extended periods after birth. At present, p24 antigen testing is also not recommended because of low sensitivity and specificity relative to other virologic assays in the early months after birth.11 The qualitative HIV-1 RNA TMA assay can be used as the initial test. Positive results need to be followed up with a repeat virologic test on a second sample.11

Table 1. Laboratory Tests Used for Screening and Diagnosis of HIV Infection

Test Code Test Name Primary Clinical Use and/or Differentiating Factors
91431 HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexesa Screen for and confirm HIV-1 and HIV-2 infection, including acute infection; uses “fourth-generation” screening immunoassay; reflexes are consistent with CDC proposed algorithm
16185 HIV-1 RNA, Qualitative TMA Detect HIV-1 infection, including acute infection; confirm HIV-1 infection in individuals with repeatedly reactive initial results, including those with nonreactive HIV-supplemental test results; detect HIV-1 infection in infants up to 24 months of age
34977 HIV-2 DNA/RNA Qualitative Real-Time PCRb,c Follow-up evaluation of negative results on confirmatory HIV-1 RNA testing, when clinically indicated5

a

Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).

b

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

c

Polymerase chain reaction (PCR) is performed pursuant to a license agreement with Roche Molecular Systems, Inc.

Management

This section provides a brief overview of tests used in the management of HIV infection (Figure) along with lists of commonly ordered assays (Tables 2 and 3).

Figure. Laboratory Tests Used in the Management of Confirmed HIV-1 Infection

Monitoring Immune Status and Viral Load

CD4 (Lymphocyte Subset Testing)

The CD4+ T-cell (CD4) count is the most valuable indicator of immune status in HIV-infected patients and is an important factor in determining when to initiate prophylaxis for opportunistic infections.13 Although antiretroviral therapy is recommended for all patients with HIV-1 infection, CD4 count still provides an indication of the urgency of beginning treatment. For patients who do not immediately begin therapy, CD4 counts should be monitored every 3-6 months.13 CD4 measurement also serves as the strongest predictor of disease progression and survival.13 In general, the risk of opportunistic infections and HIV-1-associated malignancies increases as the CD4 count decreases. The trend in counts is more important than any single value; a 30% or greater change in the absolute CD4 count between tests, or a 3-percentage point change in the CD4 percentage, is considered clinically significant.13

The CD4 count should be measured 3 months after antiretroviral treatment is initiated and then every 3 to 6 months to help assess immunologic response and the need to initiate or discontinue treatment for opportunistic infections.13 After 2 years of antiretroviral treatment, CD4 counts can be measured less frequently (every 12 months) for stable patients with suppressed viremia unless new treatment with interferon, corticosteroids, or antineoplastic agents is initiated.13

CD4 counts exhibit substantial diurnal variation (counts are generally lower in the morning) and may be affected by medications or transiently depressed by an intercurrent illness. Because of the potentially wide biologic variation, obtaining 2 measurements may be advisable if the CD4 count will affect treatment decisions; a third measurement would be required if the results are discordant.

HIV-1 RNA, Quantitative

HIV-1 viral load is the primary marker of antiretroviral treatment effectiveness. Before treatment initiation, the viral load provides information on the risk of disease progression and establishes a baseline for assessing the effect of antiviral treatment. After treatment is initiated, a primary goal is to decrease the viral load below the limits of detection (LODs) of the available assays within 12 to 24 weeks.13 Thereafter, viral load measurement is useful in assessing the continuing effectiveness of therapy. A confirmed viral load >200 copies/mL indicates virologic failure.13

The recommended frequency of viral load testing depends on the stage of disease management13:

  • Entry into care/prior to treatment initiation: at the time of diagnosis; repeat testing in patients not initiating treatment is optional

  • Start of treatment: immediately prior to initiation of therapy and every 4 to 8 weeks after treatment initiation until viral load decreases below the level of detection (<20 to 75 copies/mL)

  • Change in regimen because of suboptimal viral suppression: 2 to 8 weeks after change

  • Change in regimen because of treatment toxicity or regimen simplification: 4 to 8 weeks to assess the effectiveness of the new regimen

  • Continuing therapy/stable antiretroviral regimen: every 3 to 4 months or when there is a clinical event or significant decline in CD4 count; consider longer intervals (every 6 months) for patients who are adherent to therapy and exhibit long-term suppression of viral load (˃2 years) and stable immunologic status

Quest Diagnostics offers an FDA-cleared HIV-1 real-time polymerase chain reaction (PCR) assay for quantitation of HIV-1 RNA in plasma. A change in viral load of 3-fold (0.5 log10 copies/mL) or greater is considered statistically significant.13

Table 2. Laboratory Tests Used for Monitoring HIV-1 Infectiona

Test Code Test Name Primary Clinical Use and/or Differentiating Factors

Lymphocyte Subset Testing

8360

Lymphocyte Subset Panel 5

Includes absolute lymphocyte count, absolute CD4, and percentage CD4.

Monitor urgency of therapy initiation; monitor cellular immunocompetence

HIV-1 Viral Load Testing

40085

HIV-1 RNA, Quantitative, Real-Time PCRb

Evaluate prognosis; assess effectiveness of ART and need to switch treatment regimen

Reportable range: 20–10,000,000 HIV-1 RNA copies/mL

91691 HIV-1 RNA, Quantitative Real-Time PCR with Reflex to Genotype (RTI, PI, Integrase)b,c

Evaluate prognosis; assess effectiveness of ART and need to switch treatment regimen. See Table 3 for clinical use of genotypic assays.

ART, antiretroviral therapy.

a

This test listing is not intended to be comprehensive. For additional testing options, consult the Quest Diagnostics online Test Center (QuestDiagnostics.com/testcenter). Components of panels and reflex tests may be ordered individually.

b

Polymerase chain reaction (PCR) is performed pursuant to a license agreement with Roche Molecular Systems, Inc.

c

Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).

Antiretroviral Drug Selection

HIV-1 Drug Resistance Testing

The development of drug-resistant HIV-1 variants is an important cause of virologic failure (ie, persistent viremia in the presence of drug treatment). Resistance assays are useful for selecting active drugs when changing regimens because of virologic failure or suboptimal reduction in viral load. Genotypic testing is recommended for patients on their first or second regimen, with the addition of phenotypic testing for patients with complex drug resistance patterns.13 Ideally, testing should be performed on samples obtained while the patient is still receiving the failing regimen. If samples are taken beyond 4 weeks after a drug is withdrawn, resistant variants may not be detected but may re-emerge if the drug is reinstated. Because drug-resistant HIV-1 variants can be transmitted and may affect response to the initial drug regimen, resistance testing (preferably genotypic) is recommended upon entry into care; if therapy is not begun soon after entry into care, resistance testing may be repeated before treatment initiation to guide selection of the starting regimen.13

Quest Diagnostics offers genotypic resistance testing with a rules-based resistance prediction.

HIV-1 Genotype

HIV-1 genotyping identifies mutations that may confer drug resistance. Quest Diagnostics employs a rules-based algorithm developed by experts to interpret the results of this mutation analysis. Thus, predicted drug resistance patterns are reported in addition to the actual mutations. Tests for resistance to currently available protease, reverse transcriptase, and integrase strand transfer inhibitors are available (see Table 3).

The absence of resistance-associated mutations does not necessarily imply drug susceptibility; mutations in minor viral populations may not be detected but may become predominant in the future.

HIV-1 Coreceptor Tropism Testing

HIV-1 coreceptor tropism testing helps determine eligibility for treatment with CCR5 antagonists, a class of entry inhibitor. HIV-1 utilizes the CD4 cell surface receptor and 1 of 2 chemokine receptors, CCR5 or CXCR4, to infect cells. CCR5 antagonists such as maraviroc inhibit HIV-1 by binding to CCR5 and are only effective against R5-tropic viruses, which exclusively utilize the CCR5 coreceptor. They do not effectively inhibit either X4-tropic viruses, which exclusively utilize the CXCR4 coreceptor, or dual/mixed (D/M)-tropic viruses, which can utilize both X4 and R5. About 15% to 20% of treatment-naïve and 50% of treatment-experienced patients harbor X4 and D/M viruses.14 Thus, tropism testing is required before initiating an R5 antagonist to exclude patients with X4 or D/M tropic virus.

Phenotypic tropism testing is generally preferred because of a greater weight of supporting evidence, but genotypic tropism testing is considered an alternative because of its lower cost and faster analytical times.13 The Quest Diagnostics' genotypic tropism test is comparable to a high-sensitivity phenotypic test in distinguishing between virologic responders and nonresponders.15 It utilizes next-generation DNA sequencing (ultradeep sequencing) to detect HIV-1 envelope V3 variants associated with X4 and R5 utilization.

Standard coreceptor tropism testing requires a viral load of at least 1,000 HIV-1 RNA copies/mL. For patients with lower viral loads, the sequencing assay can be performed on proviral HIV-1 DNA rather than HIV-1 RNA.

HLA-B*5701 Typing

The nucleoside reverse transcriptase inhibitor abacavir is associated with a 2% to 9% risk of a hypersensitivity reaction.16 Susceptibility to this serious and sometimes fatal reaction has been associated with a specific human genetic variation known as HLA-B*5701. Pharmacogenetic screening for HLA-B*5701 is recommended for abacavir-naïve patients and before reinitiation of abacavir in previously treated patients.16 A negative result indicates that the patient is unlikely to have a hypersensitivity reaction to abacavir, but does not rule out this possibility. A positive result indicates that alternatives to abacavir should be used for treatment. This test uses PCR amplification followed by hybridization with sequence-specific oligonucleotide probes to detect the HLA-B*5701 allele.

Table 3. Laboratory Tests Used for Selection of Antiretroviral Drugsa
Test Code Test Name Primary Clinical Use and/or Differentiating Factors
34949

HIV-1 Genotypeb

Detect mutations associated with resistance to RTI and PI
91692 HIV-1 Genotype (RTI, PI, Integrase Inhibitors)b Detect mutations associated with resistance to RTIs, PIs, and integrase inhibitors
94015 HIV-1 Genotype and Coreceptor Tropism, Ultradeep Sequencingb,c Detect mutations associated with resistance to RTI and PI; evaluate eligibility for therapy with CCR5 antagonist
16868

HIV-1 Integrase Genotypeb

Assess mutations associated with resistance to integrase inhibitors (raltegravir, elvitegravir, and dolutegravir)
94014 HIV-1 Coreceptor Tropism, Ultradeep Sequencingb,c Evaluate eligibility for therapy with CCR5 antagonist (genotypic assay)
91299

HIV-1 Coreceptor Tropism, Proviral DNAb

Evaluate eligibility for therapy with CCR5 antagonist (genotypic assay) in patients with low viral load (<1,000 HIV-1 RNA copies/mL)
19774 HLA-B*5701 Typingd Assess risk of abacavir hypersensitivity reaction

PI, protease inhibitors; RTI, reverse transcriptase inhibitors.

a

This test listing is not intended to be comprehensive. For additional testing options, consult the Quest Diagnostics online Test Center (QuestDiagnostics.com/testcenter). Components of panels and reflex tests may be ordered individually.

b

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes..

c

Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).

d

Typing performed by using AS-PCR with reflex to the FDA-cleared LABType® SSO Kit. The AS-PCR portion of the test was developed and its performance characteristics have been determined by Quest Diagnostics.

Monitoring Patient Health

Blood Count, Basic Chemistry, Glucose, and Lipid Testing

Both HIV infection and the drugs used to treat it can have adverse effects on various organ systems. Moreover, because patients with HIV infection now tend to live normal lifespans, more emphasis is being given to routine screening. Periodic monitoring of patient health after entry into care typically includes complete blood count, basic chemistry tests, markers of liver and kidney function and bone health, and evaluation of fasting glucose and lipid profile (Figure). Please see current guidelines for comprehensive monitoring recommendations12,13 and refer to the Quest Diagnostics' online Test Center for testing options.

Testing for Comorbid Conditions

Table 4 describes tests used to evaluate conditions that are often associated with HIV infection. Current guidelines address testing for several comorbid infectious diseases, including tuberculosis, viral hepatitis (A, B, and C), trichomoniasis, cytomegalovirus, varicella zoster virus, chlamydia, gonorrhea, syphilis, and Toxoplasma gondii infection.12 HPV screening and Pap testing for cervical and anal neoplasia should also be considered in the context of a patient’s clinical history.12

Table 4. Laboratory Tests for Comorbid Conditions in Individuals with HIV-1 Infection Entering Carea
Test Code Test Name Primary Clinical Use
Chlamydia and Gonorrhea Testing
11361 Chlamydia trachomatis RNA, TMA (urine or swab) Detect infection with C trachomatis
16505 Chlamydia trachomatis RNA, TMA, Rectalb
70048 Chlamydia trachomatis RNA, TMA, Throatb
11362 Neisseria gonorrhoeae RNA, TMA (urine or swab) Detect infection with N gonorrhoeae
16504 Neisseria gonorrhoeae RNA, TMA, Rectalb
70049 Neisseria gonorrhoeae RNA, TMA, Throatb
16506 Chlamydia trachomatis/Neisseria gonorrhoeae RNA, TMA, Rectalb Detect infection with C trachomatis or N gonorrhoeae
70051 Chlamydia trachomatis/Neisseria gonorrhoeae RNA, TMA, Throatb
11363 SureSwab® Chlamydia trachomatis/ Neisseria gonorrhoeae RNA, TMA
91448 Chlamydia/N gonorrhoeae and T vaginalis RNA, Qualitative TMA, Pap Vialc

Detect infection with C trachomatis,
N gonorrhoeae, or Trichomonas vaginalis

16492

SureSwab®, CT/NG, T vaginalis

Hepatitis (Viral) Testing

508 Hepatitis A Antibody, Total Indicates prior or acute infection with, or immunization to, hepatitis A virus
498 Hepatitis B Surface Antigen with Reflex to Confirmationd First-line diagnostic test for acute hepatitis B; indicates chronic hepatitis when still positive 6 months after diagnosis of acute HBV infection
556 Hepatitis Be Antibody Indicator of resolution or carrier state when interpreted along with the other hepatitis B markers
555 Hepatitis Be Antigen Indicator of active viral replication and high infectivity
34181 Hepatitis B Virus DNA, Qualitative, Real-Time PCRb,e Indicator of chronic hepatitis when still positive 6 months after diagnosis of acute HBV infection; indicator of viral replication in patients with mutant HBV (eg, HBeAg- and HBeAb+ individuals)
8472 Hepatitis C Antibody with Reflex to HCV RNA, Quantitative Real-Time PCRd Screen for and confirm presence of HCV infection; establish viral load at baseline
35645 Hepatitis C Viral RNA, Quantitative Real-Time PCRe Confirm HCV infection; establish viral load at baseline; determine duration of treatment
Syphilis Testing
36126

RPR Diagnosis with Reflex to Titer and Confirmatory Testingd

Includes RPR screen with reflex to titer and fluorescent treponemal antibody.

Detect non-treponemal (reagin) antibodies associated with syphilis
90349

Syphilis Antibody Cascading Reflexd

Includes Treponema pallidum antibody immunoassay and reflex to RPR screen, which reflexes to either RPR titer or T pallidum antibody particle agglutination assay.

Detect and confirm presence of antibody to T pallidum
653 Treponema pallidum Ab, Particle Agglutination Confirm presence of antibody to
T pallidum
Toxoplasma Testing
3679 Toxoplasma Antibody (IgG)

Screen for T gondii infection

Trichomoniasis Testing
19550

SureSwab® Trichomonas vaginalis RNA, Qualitative TMA

Detect infection with T vaginalis
90521 Trichomonas vaginalis RNA, Qualitative TMA, Pap Vial
91448 Chlamydia/N gonorrhoeae and T vaginalis RNA, Qualitative TMA, Pap Vialc Detect infection with C trachomatis,
N gonorrh
oeae, or Trichomonas vaginalis
16492 SureSwab®, CT/NG, T vaginalis
Tuberculosis Testing
16603

QuantiFERON® TB Gold (Draw Site Incubated)

Detect infection with Mycobacterium tuberculosis
Cancer Screening (Cervical and Anal-rectal)
18810

SurePath™ Imaging Papf

14471

SurePath™ [Non Imaging] Papf

58315

ThinPrep® Imaging System Papf

Detect abnormal cervical cytology including cervical cancer; assess presence or absence of high risk HPV types
35455 ThinPrep® [Non Imaging] Papf
18811

SurePath™ Imaging Pap reflex HPV mRNA E6/E7d,f

Reflexes to HPV if ASCUS

90934

ThinPrep® Imaging Pap reflex HPV mRNA E6/E7d,f

Reflexes to HPV if ASCUS

15095 SurePath™ Pap and HPV mRNA E6/E7b,f
90931

ThinPrep® Pap and HPV mRNA E6/E7f

15949

HPV DNA, High Risk, Anal-Rectalb

Detect anorectal infection with HPV types associated with high risk of cancer
90887 HPV mRNA E6/E7 Detect infection with HPV types associated with high risk of cervical cancer
91826 HPV Genotypes 16, 18/45
90942 HPV mRNA E6/E7 with Reflex to Genotypes 16,18/45d

ASCUS, atypical squamous cells of undetermined significance; CT, Chlamydia trachomatis; NG, Neisseria gonorrhoeae; RPR, rapid plasma regain; TB, tuberculosis; TMA, transcription-mediated amplification.

a

This test listing is not intended to be comprehensive. For additional testing options, including cervical cytology and sexually transmitted infection (STI) testing using liquid-based cytology samples, consult the Quest Diagnostics online Test Center (QuestDiagnostics.com/testcenter). Components of panels and reflex tests may be ordered individually.

b

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

c

The analytical performance characteristics of this assay when used to test SurePath™ specimens have been determined by Quest Diagnostics. Performance characteristics refer to the analytical performance of the test.

d

Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).

e

Polymerase chain reaction (PCR) is performed pursuant to a license agreement with Roche Molecular Systems, Inc.

f

Pap results requiring physician interpretation will be performed at an additional charge and associated with an additional CPT code(s).

Appendix. Antiretroviral Drugs Commonly Used in the Treatment of HIV Infection
Drug or Drug Combination Abbreviation Brand Name
Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs)
Abacavir ABC

Ziagen®

Abacavir/lamivudine ABC/3TC

Epzicom®

Abacavir/zidovudine/lamivudine ABC/ZDV/3TC

Trizivir®

Emtricitabine FTC

Emtriva®

Lamivudine 3TC

Epivir®

Lamivudine/zidovudine ZDV/3TC

Combivir®

Tenofovir alafenamide/emtricitabine TAF/FTC Descovy®
Tenofovir disoproxil fumarate TDF

Viread®

Tenofovir disoproxil fumarate/emtricitabine TDF/FTC

Truvada®

Zidovudine ZDV (AZT)

Retrovir®

Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Efavirenz EFV

Sustiva®

Etravirine ETR

Intelence®

Nevirapine NVP

Viramune®

Rilpivirine RPV

Edurant®

Protease Inhibitors (PIs)
Atazanavir/cobicistat ATV/c

Evotaz®

Atazanavir/ritonavir ATV/r

Reyataz®/Norvir®

Darunavir/cobicistat DRV/c

Prezcobix®

Darunavir/ritonavir DRV/r

Prezista®/Norvir®

Fosamprenavir/ritonavir FPV/r

Lexiva®/Norvir®

Indinavir/ritonavir IDV/r

Crixivan®/Norvir®

Lopinavir/ritonavir LPV/r

Kaletra®

Saquinavir/ritonavir SQV/r

Fortovase® or Invirase®/Norvir®

Tipranavir/ritonavir TPV/r

Aptivus®/Norvir®

Entry Inhibitor (CCR5 Co-receptor Antagonist)

Maraviroc MVC

Selzentry®

Integrase Strand Transfer Inhibitor
Dolutegravir DTG

Tivicay®

Elvitegravir EVG Vitekta®
Raltegravir RAL

Isentress®

Multiclass Combination Therapy
Dolutegravir, abacavir, lamivudine DTG/ABC/3TC

Triumeq®

Efavirenz, emtricitabine, tenofovir EFV/FTC/TDF

Atripla®

Emtricitabine, rilpivirine, tenofovir disoproxil fumarate FTC/RPV/TDF Complera®
Emtricitabine, rilpivirine, tenofovir alafenamide FTC/RPV/TAF Odefsey®
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide EVG/COBI/FTC/TAF

Genvoya®

Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate EVG/COBI/FTC/TDF

Stribild®

References

  1. Centers for Disease Control and Prevention. HIV testing. http://www.cdc.gov/hiv/testing/. Updated June 20, 2016. Accessed October 3, 2016.

  2. Masciotra S, McDougal JS, Feldman J, et al. Evaluation of an alternative HIV diagnostic algorithm using specimens from seroconversion panels and persons with established HIV infections. J Clin Virol. 2011;52(suppl 1):S17-S22.

  3. Wesolowski LG, Delaney KP, Hart C, et al. Performance of an alternative laboratory-based algorithm for diagnosis of HIV infection utilizing a third generation immunoassay, a rapid HIV-1/HIV-2 differentiation test and a DNA or RNA-based nucleic acid amplification test in persons with established HIV-1 infection and blood donors. J Clin Virol. 2011;52(suppl 1):S45-S49.

  4. Branson BM. The future of HIV testing. J Acquir Immune Defic Syndr. 2010;55(suppl 2):S102-S105.

  5. CLSI. Criteria for laboratory testing and diagnosis of human immunodeficiency virus infection; approved guideline. M53-A ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.

  6. Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS. 2003;17:1871-1879.

  7. ARCHITECT HIV Ag/Ab Combo [package insert]. Wiesbaden, Germany: Abbott Laboratories; 2009.

  8. Nasrullah M, Wesolowski LG, Meyer WA, III, et al. Performance of a fourth-generation HIV screening assay and an alternative HIV diagnostic testing algorithm. AIDS. 2013;27:731-737.

  9. Chavez P, Wesolowski L, Patel P, et al. Evaluation of the performance of the Abbott ARCHITECT HIV Ag/Ab Combo Assay. J Clin Virol. 2011;52(suppl 1):S51-S55.

  10. Owen SM, Yang C, Spira T, et al. Alternative algorithms for human immunodeficiency virus infection diagnosis using tests that are licensed in the United States. J Clin Microbiol. 2008;46:1588-1595.

  11. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the use of antiretroviral agents in pediatric HIV infection. Department of Health and Human Services. https://aidsinfo.nih.gov/
    contentfiles/lvguidelines/pediatricguidelines.pdf
    . Updated March 1, 2016. Accessed September 1, 2016.

  12. Aberg JA, Gallant JE, Ghanem KG, et al. Executive Summary: Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2014;58:1-10.

  13. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. https://aidsinfo.nih.gov/
    contentfiles/lvguidelines/adultandadolescentgl.pdf
    . Updated July 14, 2016. Accessed September 1, 2016.

  14. Hunt PW, Harrigan PR, Huang W, et al. Prevalence of CXCR4 tropism among antiretroviral-treated HIV-1-infected patients with detectable viremia. J Infect Dis. 2006;194:926-930.

  15. Kagan RM, Johnson EP, Siaw M, et al. A genotypic test for HIV-1 tropism combining Sanger sequencing with ultradeep sequencing predicts virologic response in treatment-experienced patients. PLoS One. 2012;7:e46334.

  16. Information for Healthcare Professionals: Abacavir (marketed as Ziagen) and abacavir-containing medications. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm123927.htm. Published July 24, 2008. Updated August 15, 2013. Accessed September 1, 2016.

Content reviewed 10/2016

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* The tests listed by specialist are a select group of tests offered. For a complete list of Quest Diagnostics tests, please refer to our Directory of Services.