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HIV Infection and AIDS

Guidelines

CDC Guidelines on HIV Screening in Men Who Have Sex with Men

The following are guidelines on HIV screening among men who have sex with men (MSM)^[160]:

The CDC concludes that the evidence, programmatic experience, and expert opinions are insufficient to warrant changing the recommendation of annual screening for men who have sex with men (MSM) to more frequent screening (every 3 or 6 months).
Providers in clinical settings should offer HIV screening at least annually to all sexually active MSM.
Clinicians can also consider the potential benefits of more frequent HIV screening (eg, every 3 or 6 months) for some asymptomatic sexually active MSM based on their individual risk factors, local HIV epidemiology, and local policies.
Among MSM who are prescribed preexposure prophylaxis, HIV testing every 3 months and immediate testing whenever signs and symptoms of acute HIV infection are reported is indicated.
MSM who experience a specific high-risk sexual exposure or have symptoms of recent HIV infection should seek immediate HIV testing, and clinicians should be alert for the symptoms of acute HIV infection and provide appropriate diagnostic testing.
Tenofovir alafenamide (TAF)/emtricitabine (FTC) is now included as an alternative for pre-exposure prophylaxis (PrEP) in men who have sex with men (MSM).

European AIDS Clinical Society Guidelines

The European AIDS Clinical Society (EACS) has issued updated guidelines on the management of HIV infection. In this latest version of the guidelines (version 10), a new drug-drug interaction panel has been introduced. The guidelines have six main sections, including a general overview table of all major issues in patients living with HIV infection; recommendations on antiretroviral treatment (ART); drug-drug interactions; and diagnosis, monitoring, and treatment of comorbidities, coinfections, and opportunistic diseases.^[161]

Antiretroviral therapy

A new recommendation in the updated guideline favors an unboosted integrase strand transfer inhibitor (INSTI) with high genetic barrier (bictegravir [BIC] or dolutegravir [DTG]) as a third agent for therapy initiation in treatment-naïve individuals with HIV infection.

Two nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus doravirine (DOR) has been included among the recommended regimens.

Tenofovir disoproxil fumarate (TDF)/lamivudine (3TC) has been added as a backbone, when indicated.

DTG plus 3TC dual therapy has been upgraded as a recommended regimen.

High-genetic-barrier INSTI or protease inhibitors pharmacologically boosted with cobicistat or ritonavir (PI/b) are recommended as initial therapy for primary HIV infection if resistance testing is unavailable.

Ritonavir- or cobicistat-boosted darunavir (DRV/b) plus rilpivirine (RPV) has been included as a dual-therapy option.

Monotherapy with PI/b is not recommended.

Initiation of ART in patients with tuberculosis (TB) and HIV coinfection who have a CD4 cell count of more than 50/µL may be deferred up to 8 weeks after TB treatment has been started.

Tenofovir alafenamide (TAF)/emtricitabine (FTC), raltegravir (RAL) once daily, and bictegravir (BIC) have been added as potential drugs for postexposure prophylaxis (PEP).

TAF/FTC is now included as an alternative for pre-exposure prophylaxis (PrEP) in men who have sex with men (MSM) and transgender women.

Comorbidities

Screening for kidney disease should incorporate albumin/creatinine ratio for glomerular disease and protein/creatinine ratio for screening for and diagnosing antiretroviral-related tubulopathy.

Lipid targets have been updated in terms of the threshold for ART modification, from 20% 10-year risk for cardiovascular disease (CVD) to 10% 10-year risk for CVD.

Medical management of hypertension has been updated to include amended drug-sequencing suggestions and recommended drugs.

The workup of liver disease among individuals with HIV infection should now include a fourth step to include risk stratification based on risk prediction tools and transient elastography and an updated algorithm for surveillance of varices.

Department of Health and Human Services

The US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents has published guidelines to help providers integrate treatment as prevention (TasP) into their clinical practice. The Panel emphasizes the importance of screening and early diagnosis of HIV. In order for persons with HIV to benefit from early diagnosis, the Panel recommends that ART be started immediately or as soon as possible after diagnosis to increase the uptake of ART, decrease the time required to achieve linkage to care and virologic suppression for individual patients, reduce the risk of HIV transmission, and improve the rate of virologic suppression among persons with HIV.^[162]

The guidelines recommend the following:

An initial antiretroviral (ARV) regimen for a treatment-naive patient generally consists of two nucleoside reverse transcriptase inhibitors (NRTIs) administered in combination with a third active ARV drug from one of three drug classes: an integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a protease inhibitor (PI) with a pharmacokinetic (PK) enhancer (also known as a booster; the two drugs used for this purpose are cobicistat and ritonavir).
Data also support the use of the two-drug regimen, dolutegravir plus lamivudine, for initial treatment.
Before initiating antiretroviral therapy (ART) in a person of childbearing potential, clinicians should discuss the person’s intentions regarding pregnancy and a pregnancy test should be performed (AIII). Clinicians should refer to the Perinatal Guidelines for recommendations on initial ARV regimen for an ART-naive person around the time of conception and during pregnancy.

The Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) classifies the following regimens as Recommended Initial Regimens for Most People with HIV (in alphabetical order):

For those with HIV who have no prior use of long-acting cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP), the following regimens are recommended:

Bictegravir/tenofovir alafenamide/emtricitabine (AI) (There are insufficient data to recommend Bictegravir during pregnancy.)
Dolutegravir/abacavir/lamivudine—only for individuals who are HLA-B*5701 negative and without chronic hepatitis B virus (HBV) coinfection (AI)
Dolutegravir plus (emtricitabine or lamivudine) plus (tenofovir alafenamide [TAF] or tenofovir disoproxil fumarate [TDF]) (AI)
Dolutegravir/lamivudine (AI)—except for individuals with HIV RNA >500,000 copies/mL, HBV coinfection, or when ART is to be started before the results of HIV genotypic resistance testing for reverse transcriptase or HBV testing are available.

For those with HIV and prior use of CAB-LA as PrEP, INSTI genotypic resistance testing should be done before beginning ART. If treatment is begun before receiving results of genotypic testing, the following regimen is recommended:

Boosted darunavir plus (TAF or TDF) plus (FTC or 3TC)—pending the results of the genotype test (AIII).

DHHS guidelines further recommend the following:

To address individual patient characteristics and needs, the Panel also provides a list of Recommended Initial Regimens in Certain Clinical Situations (see Table 6 below).
Given the many excellent options for initial therapy, selection of a regimen for a particular patient should be guided by such factors as virologic efficacy, toxicity, pill burden, dosing frequency, drug-drug interaction potential, resistance test results, comorbid conditions, access, and cost. Table 7 provides guidance on choosing an ARV regimen based on selected clinical case scenarios. Table 9 highlights the advantages and disadvantages of different components in a regimen.
Patients without prior ART who wish to begin long-acting intramuscular cabotegravir (CAB) and rilpivirine (RPV) should first achieve viral suppression on another regimen before shifting to oral, and then injectable, CAB and RPV (see Optimizing Antiretroviral Therapy in the Setting of Virologic Suppression).

Medication

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Media Gallery

Electron microscopy of human immunodeficiency virus (HIV)–1 virions. Courtesy of CDC (Dr Edwin P Ewing, Jr).
Genome layout of human immunodeficiency virus (HIV)–1 and HIV-2.
Timeline of CD4 T-cell and viral-load changes over time in untreated human immunodeficiency virus (HIV) infection. Courtesy of Wikipedia (based on an original from Pantaleo et al (1993)).
Incidence of HIV infection by risk group. Courtesy of CDC (derived from the revised 2006 estimated figures).
Changes in survival of people infected with HIV. As therapies have become more aggressive, they have been more effective, although survival with HIV infection is not yet equivalent to that in uninfected people. Modified from Lohse N et al. Survival of persons with and without HIV infection in Denmark, 1995-2005. Ann Intern Med. 2007;146(2):87-95.

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Table 1. Antiretroviral Drug Classes and Agents

Nucleoside reverse transcriptase inhibitors (NRTIs)	Abacavir (Ziagen, ABC) Didanosine (Videx, Videx EC, ddI) Emtricitabine (Emtriva, FTC) Lamivudine (Epivir, 3TC) Stavudine (Zerit, Zerit XR, d4T) Tenofovir DF (Viread, TDF) Tenofovir AF (TAF) Zalcitabine (Hivid, ddC)* Zidovudine (Retrovir, ZDV, AZT)
Protease inhibitors (PIs)	Amprenavir (Agenerase, AVP)* Atazanavir (Reyataz , ATV) Darunavir (Prezista, DRV) Fosamprenavir (Lexiva, f-APV) Indinavir (Crixivan, IDV) Lopinavir and ritonavir (Kaletra, LPV/r) Nelfinavir (Viracept, NFV) Ritonavir (Norvir, RTV) Saquinavir (Invirase [hard gel] capsule, SQV) Tipranavir (Aptivus, TPV)
Non-nucleoside reverse transcriptase inhibitors (NNRTIs)	Delavirdine (Rescriptor, DLV) Efavirenz (Sustiva, EFV) Etravirine (Intelence, ETR) Nevirapine (Viramune, NVP) Rilpivirine (Edurant) Doravirine (Pifeltro, DOR) Cabotegravir (CAB)
Fusion inhibitors	Enfuvirtide (Fuzeon, T-20)
Cellular chemokine receptor (CCR5) antagonists	Maraviroc (Selzentry, MVC)
Integrase inhibitors	Raltegravir (Isentress, RAL) Dolutegravir (Tivicay, DTG) Elvitegravir (Vitekta, EVG)
Entry inhibitors (CD4 post-attachment inhibitors)	Ibalizumab (Trogarzo, IBA)
gp120 Attachment inhibitors	Fostemsavir (Rukobia, FTR)
Capsid inhibitors	Lenacapavir (Sunlenca, LEN)
*No longer available on market

Table 2. Antiretroviral Combination Products

Drug Content per Tablet/Capsule*	Brand Name	Adult Dose (≥40 kg)
Darunavir 800 mg Cobicistat 150 mg Emtricitabine 200 mg Tenofovir AF 10 mg	Symtuza^#	1 tab PO qd with food
Bictegravir 50 mg Emtricitabine 200 mg Tenofovir AF 25 mg	Biktarvy^#	1 tab PO qd
Efavirenz 400 mg Lamivudine 300 mg Tenofovir DF 300 mg	Symfi Lo^#	1 tab PO qHS on an empty stomach
Efavirenz 600 mg Lamivudine 300 mg Tenofovir DF 300 mg	Symfi^#	1 tab PO qHS on an empty stomach
Dolutegravir 50 mg Rilpivirine 25 mg	Juluca^#	1 tab PO qd with a meal Note: This is a complete once-daily regimen in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable ART regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance
Dolutegravir 50 mg Lamivudine 300 mg	Dovato^#	1 tab PO qd with or without food Note: This a complete once-daily regimen in treatment-naïve adults with no known substitutions associated with resistance to dolutegravir or lamivudine
Elvitegravir 150 mg Cobicistat 150 mg Emtricitabine 200 mg Tenofovir AF 10 mg	Genvoya^#	1 tab PO qd
Elvitegravir 150 mg Cobicistat 150 mg Emtricitabine 200 mg Tenofovir DF 300 mg	Stribild^#	1 tab PO qd
Cabotegravir IM copackaged with Rilpivirine IM	Cabenuva^#	One-time initiating injection (on last day of oral lead-in dosing): Cabotegravir 600 mg IM plus rilpivirine 900 mg IM, THEN Once-monthly continuation injections: Cabotegravir 400 mg IM plus rilpivirine 600 mg IM
Abacavir 600 mg Lamivudine 300 mg	Epzicom	1 tab PO qd
Abacavir 600 mg Dolutegravir 50 mg Lamivudine 300 mg	Triumeq	1 tab PO qd
Abacavir 300 mg Lamivudine 150 mg Zidovudine 300 mg	Trizivir	1 tab PO bid
Efavirenz 600 mg Emtricitabine 200 mg Tenofovir DF 300 mg	Atripla^#	1 tab PO qd on empty stomach Note: May be used alone as a complete regimen or in combination with other ARTs
Emtricitabine 200 mg Rilpivirine 25 mg Tenofovir DF 300 mg	Complera^#	1 tab PO qd with a meal
Emtricitabine 200 mg Rilpivirine 25 mg Tenofovir AF 25 mg	Odefsey^#	1 tab PO qd with a meal
Emtricitabine 200 mg Tenofovir DF 300 mg	Truvada	1 tab PO qd CrCl 30-49 mL/min: 1 tab PO q48h CrCl < 30 mL/min: Do not administer
Emtricitabine 200 mg Tenofovir AF 300 mg	Descovy	1 tab PO qd CrCl < 30 mL/min: Do not administer
Lamivudine 150 mg Zidovudine 300 mg	Combivir	1 tab PO bid
Lamivudine 300 mg Tenofovir DF 300 mg	Cimduo	1 tab PO qd
Doravirine 100 mg Lamivudine 300 mg Tenofovir DF 300 mg	Delstrigo^#	1 tab PO qd with or without food
*Not indicated for patients requiring dosage adjustments (eg, weight < 40 kg, renal impairment, hepatic impairment, dose-limiting adverse effects) unless otherwise stated. ^#Complete once-daily regimen

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Author

Shelley A Gilroy, MD, FACP, FIDSA Associate Professor of Medicine, Infectious Disease and HIV Medicine, Albany Medical College; Associate Chief of Staff for Education/DEO, Lead Physician for HIV Medicine, Division of Infectious Diseases, Albany Stratton VA Medical Center

Shelley A Gilroy, MD, FACP, FIDSA is a member of the following medical societies: American College of Physicians, American Medical Association, Infectious Diseases Society of America

Disclosure: Nothing to disclose.

Coauthor(s)

John J Faragon, PharmD, BCPS, AAHIVP Pharmacist, HIV/HCV Medicine, Division of HIV Medicine and Department of Pharmacy, Albany Medical Center; Regional Pharmacy Director, Northeast Caribbean AIDS Education and Training Center; HIV and HCV Education Consultant, VirologyEd Consultants

Disclosure: Serve(d) as a speaker or a member of a speakers bureau for: Gilead; Janssen; Merck.

Chief Editor

Michael Stuart Bronze, MD David Ross Boyd Professor and Chairman, Department of Medicine, Stewart G Wolf Endowed Chair in Internal Medicine, Department of Medicine, University of Oklahoma Health Science Center; Master of the American College of Physicians; Fellow, Infectious Diseases Society of America; Fellow of the Royal College of Physicians, London

Michael Stuart Bronze, MD is a member of the following medical societies: Alpha Omega Alpha, American College of Physicians, American Medical Association, Association of Professors of Medicine, Infectious Diseases Society of America, Oklahoma State Medical Association, Southern Society for Clinical Investigation

Disclosure: Nothing to disclose.

Additional Contributors

Nicholas John Bennett, MBBCh, PhD, FAAP, MA(Cantab) Assistant Professor of Pediatrics, Co-Director of Antimicrobial Stewardship, Medical Director, Division of Pediatric Infectious Diseases and Immunology, Connecticut Children's Medical Center

Nicholas John Bennett, MBBCh, PhD, FAAP, MA(Cantab) is a member of the following medical societies: Alpha Omega Alpha, American Academy of Pediatrics

Disclosure: Received research grant from: Cubist<br/>Received income in an amount equal to or greater than $250 from: Horizon Pharmaceuticals, Shire<br/>Medico legal consulting for: Various.

Acknowledgements

Aaron Glatt, MD Professor of Clinical Medicine, New York Medical College; President and CEO, Former Chief Medical Officer, Departments of Medicine and Infectious Diseases, St Joseph Hospital (formerly New Island Hospital)

Aaron Glatt, MD is a member of the following medical societies: American College of Chest Physicians, American College of Physician Executives, American College of Physicians, American College of Physicians-American Society of Internal Medicine, American Medical Association, American Society for Microbiology, American Thoracic Society, American Venereal Disease Association, Infectious Diseases Society of America, International AIDS Society, and Society forHealthcare Epidemiology of America

Disclosure: Nothing to disclose.

Mary L Windle, PharmD Adjunct Associate Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Nothing to disclose.