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Updated Guidelines for Antiretroviral Postexposure

Prophylaxis After Sexual, Injection Drug Use, or

Other Nonoccupational Exposure to HIV—

United States, 2016

from the

Centers for Disease Control and Prevention,

U.S. Department of Health and Human Services

2016 nPEP Guidelines Update Page 2 of 91

Disclaimers:

All material in this publication is in the public domain and may be used and reprinted without permission;

citation as to source, however, is appreciated.

References to non-CDC sites on the Internet are provided as a service to readers and do not constitute or imply

endorsement of these organizations or their programs by CDC or the U.S.

Department of Health and Human

Services. CDC is not responsible for the content of these sites. URL addresses listed were current as of the date

of publication.

This report describes use of certain drugs and tests for some indications that do not reflect labeling approved by

the Food and Drug Administration at the time of publication. Use of trade names and commercial sources is for

identification only and does not imply endorsement by the U.S. Department of Health and Human Services.

2016 nPEP Guidelines Update Page 4 of 91

VII

-B5. Pregnancy Testing ............................................................................................................................ 30

VII

-B6. Baseline and Follow-up Testing to Assess Safety of Antiretroviral Use for nPEP .......................... 30

VII-C. Recommended Antiretroviral nPEP Regimens ............................................................................................................. 30

VII-D. Prophylaxis for STIs and Hepatitis ................................................................................................................................ 38

VII-E. Considerations for All Patients Treated with Antiretroviral nPEP ............................................................................... 39

VII

-E1. Provision of nPEP Starter Packs or a 28-day Supply at Initiation .................................................... 39

VII

-E2. Expert Consultation .......................................................................................................................... 39

VII

-E3. Facilitating Adherence ...................................................................................................................... 39

VII

-E4. HIV Prevention Counseling .............................................................................................................. 40

VII

-E5. Providing PrEP After nPEP Course Completion .............................................................................. 40

VII.E6. Providing nPEP in the

Context

of PrEP ............................................................................................ 40

VII

-E7. Management of Source Persons with HIV Infection ........................................................................ 41

VII-F. Additional Considerations ............................................................................................................................................... 41

VII

-F1. Reporting and Confidentiality ........................................................................................................... 41

VII

-F2. Special Populations ........................................................................................................................... 41

VII

-F3. Special Legal and Regulatory Concerns ........................................................................................... 44

VII

-F4. Potential Sources of Financial Assistance for nPEP Medication ...................................................... 44

VIII. Conclusion ................................................................................................................................................................... 45

VIII

-A. Plans for Updating These Guidelines....................................................................................................................... 46

IX. References ....................................................................................................................................................................... 47

X. Appendices ....................................................................................................................................................................... 59

Appendix 1A.

Summary of Methods for nPEP Guidelines Development and Roles of Teams and Consultants..................... 60

Appendix 1B.

nPEP Guidelines Development Teams and Consultants ........................................................................................ 62

Appendix 1C.

Financial Disclosures of Potential Competing Interest nPEP Guidelines Consultants and Working Group .... 64

Appendix 2. Literature Search Methods for the nPEP Guidelines .................................................................................................. 67

Appendix 3. Studies Reviewed for the nPEP Guidelines ................................................................................................................ 68

Appendix 4. Consideration of Other Alternative HIV nPEP Antiretroviral Regimens ................................................................ 91

2016 nPEP Guidelines Update Page 5 of 91

I. LIST OF TABLES AND FIGURES

Figure 1. Algorithm for evaluation and treatment of possible nonoccupational HIV exposures ......................................... 23

Table 1.

Estimated per-act risk for acquiring human immunodeficiency virus (HIV) from an infected source, by exposure

act .......................................................................................................................................................... 25

Table 2.

Recommended schedule of laboratory evaluations of source and exposed persons for providing nPEP with preferred regimens

................................................................................................................................................ 27

Table 3. Clinical signs and symptoms of acute (primary) human immunodeficiency virus infection ............................... 28

Table 4.

Hepatitis B virus screening serology .................................................................................................................... 29

Table 5.

Preferred and

alternative antiretroviral medication 28-day regimens for nPEP ................................................... 31

Table 6.

Formulations, cautions, and dose adjustments for antiretroviral medications in preferred and alternative

nPEP regimens

...................................................................................................................................................... 33

Table 7.

Antiretroviral medications that should not be used for nPEP among pregnant women ....................................... 42

Figure 2. nPEP considerations su

mmary ............................................................................................................................. 45

2016 nPEP Guidelines Update Page 6 of 91

II. ABBREVIATIONS AND ACRONYMS

3TC lamivudine

Ab antibody

Ag antigen

Ag/Ab antigen/antibody combination test

AIDS acquired immunodeficiency syndrome

Anti-HBc hepatitis B core antibody

Anti-HBs hepatitis B surface antibody

aOR adjusted odds ratio

ATV atazanavir

ATV/r ritonavir-boosted atazanavir

CAI condomless anal intercourse

CA-NSI community-acquired needlestick injury

CD4 CD4 T lymphocyte

CDC Centers for Disease Control and Prevention

CI confidence interval

d4T stavudine

DDI didanosine

DNA deoxyribonucleic acid

DRV darunavir

DRV/r ritonavir-boosted darunavir

DTG dolutegravir

DHHS U.S. Department of Health and Human Services

ED emergency department

EFV efavirenz

ELISA enzyme-linked immunosorbent assay

FDA Food and Drug Administration

FTC emtricitabine

HBsAg hepatitis B surface antigen

HBV hepatitis B virus

HIV human immunodeficiency virus

IDV indinavir

IDV/r ritonavir-boosted indinavir

IFA indirect fluorescent antibody

LPV lopinavir

2016 nPEP Guidelines Update Page 7 of 91

LPV/r ritonavir-boosted lopinavir

MSM gay, bisexual, and other men who have sex with men

NAAT nucleic acid amplification test

NFV nelfinavir

NIH National Institutes of Health

NNRTI non-nucleoside reverse transcriptase inhibitors

NRTI nucleoside reverse transcriptase inhibitors

NVP nevirapine

nPEP nonoccupational postexposure prophylaxis oPEP occupational postexposure prophylaxis

PCR polymerase chain reaction

PI protease inhibitor

PrEP preexposure prophylaxis

PWID persons who inject drugs

OR odds ratio

PCR polymerase chain reaction

PEP postexposure prophylaxis

PrEP preexposure prophylaxis

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