PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV .

1y ago
16 Views
1 Downloads
1.62 MB
59 Pages
Last View : 4m ago
Last Download : 7d ago
Upload by : Mollie Blount
Transcription

US PUBLIC HEALTH SERVICEPREEXPOSURE PROPHYLAXISFOR THE PREVENTION OF HIVINFECTION IN THE UNITEDSTATES –2017 UPDATECLINICAL PROVIDERS’ SUPPLEMENTPreexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 1 f 59

What’s New in the Preexposure Prophylaxis for the Prevention of HIV Infection in the UnitedStates – 2017 Update – Clinical Providers’ Supplement?(Published Online March 2018)The Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2014 ClinicalProviders’ Supplement was published in an electronic format in July 2014 so that it could be updated asrelevant changes in supporting evidence became available. The Preexposure Prophylaxis for thePrevention of HIV Infection in the United States - 2016 Update – Clinical Providers’ Supplementincludes revisions to several sections. These revisions are highlighted throughout the document and areintended solely to update the developing evidence base and to clarify specific points in clinical care. Nochanges were made to the graded recommendations for the use of PrEP in the US.New: Section 7 HIV Incidence Risk Index for Injection Drug UsersAdded recently published validated risk screening toolNew: Section 8 Management of Patients Who Acquire HIV While On PrEPAdded additional detail about recommended steps in the clinical management at visits whenseroconversion is detected in patients being prescribed PrEPNew: Section 9 Transition of Patients From nPEP to PrEPAdded additional detail about recommended steps in the clinical management of patients who areconcluding a course of nPEP and transitioning directly to PrEPSection 12 PrEP-related ICD, CPT, and LOINC CodesDeleted ICD-9 codes since they no longer in useSection 13 Potential PrEP Quality Practice MeasuresRevised measure of medication prescription to measure medication adherence assessmentSection 14 Methods for Developing the PrEP Clinical Practice GuidelineConsolidated all information about the guidelines development and update process into this section andprovided details about the systematic literature review methods.Preexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 2 f 59

Minor revisions were also made to correct typos, add references, and update content from citedguidelines and source materials.Preexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 3 f 59

Disclaimers:All material in this publication is in the public domain and may be used and reprinted withoutpermission; 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 orimply endorsement of these organizations or their programs by CDC or the U.S. Department of Healthand Human Services. CDC is not responsible for the content of these sites. URL addresses listed werecurrent as of the date of publication.Use of trade names and commercial sources is for identification only and does not imply endorsementby the U.S. Department of Health and Human Services.Suggested Citation:Centers for Disease Control and Prevention: US Public Health Service: Preexposure prophylaxis for theprevention of HIV infection in the United States—2017 Update: clinical providers’supplement. -provider-supplement-2017.pdf.Published March 2018.For more clinical advice about PrEP guidelines: call the National Clinicians Consultation Center PrEPline at 855-448-7737 orgo to their website at re-exposure-prophylaxis/Preexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 4 f 59

Supplementary Materials:ContentsIntr ducti n.4Secti n 1Patient/Pr vider Checklist.6Secti n 2Patient Inf rmati n Sheet – PrEP.8Secti n 3Patient Inf rmati n Sheet – Truvada.11Secti n 4Patient Inf rmati n Sheet – Acute HIV Infecti n and PrEP .14Secti n 5Pr vider Inf rmati n Sheet – PrEP During C ncepti n, Pregnancy, and Breastfeeding .16Secti n 6HIV Incidence Risk Index f r Men Wh Have Sex With Men .22Secti n 7HIV Incidence Risk Index f r Pers ns Wh Inject Drugs .24Secti n 8Management f Patients Wh Acquire HIV While n PrEP .27Secti n 9Transiti n f Patients fr m nPEP t PrEP.29Secti n 10Supplemental C unseling Inf rmati n—Medicati n Adherence .31Secti n 11Supplemental C unseling Inf rmati n—HIV Risk Reducti n .36Secti n 12PrEP-related ICD, CPT and LOINC C des .38Secti n 13P tential PrEP Practice Quality Measures.42Secti n 14Meth ds f r Devel ping the PrEP Clinical Practice Guideline .43References .51Preexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 5 f 59

IntroductionRecent findings from several clinical trials have demonstrated safety1 and a substantial reduction in therate of HIV acquisition for men who have sex with men (MSM)2, men and women in heterosexualdiscordant couples3, and heterosexual men and women recruited as individuals4 who were prescribeddaily oral antiretroviral preexposure prophylaxis (PrEP) with a fixed-dose combination of tenofovirdisoproxil fumarate (TDF) and emtricitabine (FTC). The demonstrated efficacy of PrEP was in additionto the effects of repeated condom provision, sexual risk-reduction counseling, and the diagnosis andtreatment of sexually transmitted infection (STI) that were provided to all trial participants. In July2012, after reviewing these trial results, the U.S. Food and Drug Administration (FDA) approved anindication for the use of Truvada (TDF/FTC) “in combination with safer sex practices for pre-exposureprophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk” 5,6. In July2013, an additional clinical trial found that daily oral TDF reduced the rate of HIV acquisition forpersons who inject drugs (PWID) (also called injection drug users [IDU]) 7.On the basis of these trial results and the FDA approval, the U.S. Public Health Service has published acomprehensive clinical practice guideline for the use of PrEP for the prevention of HIV infection in theUnited States and updated it in 2017. -guidelines2017.pdfThis supplement to the PHS PrEP Clinical Practice Guidelines is intended to provide additionalinformation that may be useful to clinicians providing PrEP. As additional materials become available,this document will be updated.Section 1Contains a template checklist that clinicians can complete and share with patients todocument the services provided to PrEP patients and the actions expected frompatients to maximize the efficacy and safety of PrEP.Sections 2-4Contain templates for informational handouts that can be provided to patientsSection 5Contains an information sheet for providers counseling patients about PrEP use duringconception, pregnancy and breastfeeding.Section 6Contains the HIV incidence Risk Index for MSM, a tool that clinicians may use toquickly and systematically determine which men are at especially high risk foracquiring HIV infection, for whom PrEP may be indicated.Section 7Contains the HIV incidence Risk Index for PWID, a tool that clinicians may use toquickly determine which persons who inject drugs are at especially high risk foracquiring HIV infection, for whom PrEP may be indicated.Section 8Contains more detailed information about the clinical management of patients whoacquire HIV infection while on PrEP.Section 9Contains more detailed information about the clinical management of transitioningpatients from nPEP to PrEP.Sections 10-11 Contain more detailed information than that included in the guidelines about methodsand resources for counseling patients receiving PrEP about medication adherence andHIV risk reduction behaviors.Preexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 6 f 59

Sections 12Section 13Section 14Contains information relevant to administrative and billing codes for PrEP relatedservices.Contains potential practice quality practice measures.Documents the methods used to develop the PHS PrEP Clinical Practice Guidelines.Preexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 7 f 59

Section 1 Patient/Provider ChecklistOrganization/Clinic NameCHECKLIST FOR INITIATING PREEXPOSURE PROPHYLAXIS (PrEP)Print name of providerPrint name of patientToday’s date (month/day/year)Provider SectionI have provided this patient with the following: (check all as completed): Assessment for possible acute HIV infection Indicated laboratory screening to determine indications for these medications An HIV risk assessment to determine whether PrEP is indicated for this patient A medication fact sheet listing dosing instructions and side effects Counseling or a referral for counseling on condom use and any other HIV riskreduction methods this patient may need Advice on methods to help the patient to take medication daily as prescribed Information about PrEP use during conception and pregnancy (when indicated) A prescription for Truvada (300 mg tenofovir disoproxil fumarate, 200 mg emtricitabine) A follow-up appointment dateAs the provider, I will: Limit refill periods to recommended intervals for repeat HIV testing (at least every 3 months) Conduct follow-up visits at least every 3 months that include the following:o Assessment of HIV status (including signs or symptoms of acute HIV infection)o Assessment of side effects and advice on how to manage themo Assessment of medication adherence and counseling to support adherenceo Assessment of STI symptoms, HIV risk behavior and counseling support for riskreduction practices Inform the patient of any new information about PrEP and respond to questionsPreexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 8 f 59

Patient SectionIt has been explained to me that: Taking a dose of PrEP medication every day may lower my risk of getting HIV infection This medicine does not completely eliminate my risk of getting HIV infection, so I need to usecondoms during sex This medicine may cause side effects so I should contact my provider for advice by callingif I have any health problems It is important for my health to find out quickly if I get HIV infection while I’m taking thismedication, soo I will contact my provider right away if I have symptoms of possible HIV infection(fever with sore throat, rash, headache, or swollen glands) My provider will test for HIV infection at least once every 3 monthsTherefore, I will: Try my best to take the medication my provider has prescribed every day Talk to my provider about any problems I have in taking the medication every day Not share the medication with any other person Attend all my scheduled appointments Call to reschedule any appointments I cannot attendGive one copy to patientPreexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 9 f 59

Section 2 PrEP Information SheetPre-exposure Prophylaxis (PrEP) for HIV PreventionFrequently Asked QuestionsWhat is PrEP?“PrEP” stands for preexposure prophylaxis. The word “prophylaxis” (pronounced pro fil ak sis) meansto prevent or control the spread of an infection or disease. The goal of PrEP is to prevent HIV infectionfrom taking hold if you are exposed to the virus. This is done by taking a pill that contains 2 HIVmedications every day. These are the same medicines used to stop the virus from growing in people whoare already infected.Why take PrEP?The HIV epidemic in the United States is growing. About 50,000 people get infected with HIV eachyear. More of these infections are happening in some groups of people and some areas of the countrythan in others.Is PrEP a vaccine?No. PrEP medication does not work the same way as a vaccine. When you take a vaccine, it trains thebody’s immune system to fight off infection for years. You will need to take a pill every day by mouthfor PrEP medications to protect you from infection. PrEP does not work after you stop taking it. Themedication that was shown to be safe and to help block HIV infection is called “Truvada” (pronouncedtru va duh). Truvada is a combination of 2 drugs (tenofovir and emtricitabine). These medicines workby blocking important pathways that the HIV virus uses to set up an infection. If you take Truvada asPrEP daily, the presence of the medication in your bloodstream can often stop the HIV virus fromestablishing itself and spreading in your body. If you do not take the Truvada pills every day, there maynot be enough medicine in your blood stream to block the virus.Should I consider taking PrEP?PrEP is not for everyone. Doctors prescribe PrEP for some patients who have a very high risk ofcoming in contact with HIV by not using a condom when they have sex with a person who has HIVinfection. You should consider PrEP if you are a man or woman who sometimes has sex without using acondom, especially if you have a sex partner who you know has HIV infection. You should alsoconsider PrEP if you don’t know whether your partner has HIV infection but you know that your partneris at risk (for example, your partner inject drugs or is having sex with other people in addition to you) orif you have recently been told by a health care provider that you had a sexually transmitted infection. Ifyour partner has HIV infection, PrEP may be an option to help protect you from getting HIV infectionwhile you try to get pregnant, during pregnancy, or while breastfeeding.How well does PrEP work?PrEP was tested in several large studies with men who have sex with men, men who have sex withwomen, and women who have sex with men. All people in these studies (1) were tested at the beginningof the trial to be sure that they did not have HIV infection, (2) agreed to take an oral PrEP tablet daily,Preexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 10 f 59

(3) received intensive counseling on safer-sex behavior, (4) were tested regularly for sexuallytransmitted infections, and (5) were given a regular supply of condoms.Several studies showed that PrEP reduced the risk of getting HIV infection. Men who have sex with men who were given PrEP medication to take, were 44% less likely toget HIV infection than were those men who took a pill without any PrEP medicine in it (aplacebo). Forty-four percent was an average that included men who didn’t take the medicineevery day and those who did. Among the men who said they took most of their daily doses, PrEPreduced the risk of HIV infection by 73% or more, up to 92% for some.Among men and women in couples in which one partner had HIV infection and the other partnerinitially did not (“HIV-discordant” couples), those who received PrEP medication were 75% lesslikely to become infected than those who took a pill without any medicine in it (a placebo).Among those who said they took most of their daily doses, PrEP reduced the risk of HIVinfection by up to 90%.In one study of men and women who entered the study as individuals (not as a couple), PrEPworked for both men and women in one study: those who received the medication were 62% lesslikely to get HIV infection; those who said they took most of their daily doses, were 85% lesslikely to get HIV infection. But in another study, only about 1 in 4 women ( 26%) had PrEPmedication found in their blood when it was checked. This indicated that few women wereactually taking their medication and that study found no protection against HIV infection.More information on the details of these studies can be found at http://www.cdc.gov/hiv/prep.Is PrEP safe?The clinical trials also provided safety information on PrEP. Some people in the trials had early sideeffects such as an upset stomach or loss of appetite but these were mild and usually went away withinthe first month. Some people also had a mild headache. No serious side effects were observed. Youshould tell your doctor if these or other symptoms become severe or do not go away.How can I start PrEP?If you think you may be at high risk for HIV, talk to your doctor about PrEP. If you and your doctoragree that PrEP might reduce your risk of getting HIV infection, you will need to come in for a generalhealth physical, blood tests for HIV, and tests for other infections that you can get from sex partners.Your blood will also be tested to see if your kidneys and liver are functioning well. If these tests showthat PrEP medicines are likely to be safe for you to take and that you might benefit from PrEP, yourdoctor may give you a prescription after discussing it with you.Taking PrEP medicines will require you to follow-up regularly with your doctor. You will receivecounseling on sexual behaviors and blood tests for HIV infection and to see if your body is reacting wellto Truvada. You should take your medicine every day as prescribed, and your doctor will advise youabout ways to help you take it regularly so that it stands the best chance to help you avoid HIV infection.Tell your doctor if you are having trouble remembering to take your medicine or if you want to stopPrEP.Preexp sure Pr phylaxis f r the Preventi n f HIV Infecti n in the United States – 2017 Update Clinical Pr viders’ SupplementPage 11 f 59

If I take PrEP can I stop using condoms when I have sex?You should not stop using condoms because you are taking PrEP. If PrEP is taken daily, it offers a lotof protection against HIV infection, but not 100%. Condoms also offer a lot of protection against HIVinfection if they are used correctly every time you have sex, but not 100%. PrEP medications don’t giveyou any protection from other infections you can get during sex, but condoms do. So you will get themost protection from HIV and other sexual infections if you consistently take PrEP medication andconsistently use condoms during sex.How long do I need to take PrEP?You should discuss this with your doctor. There are several reasons that people stop taking PrEP. Ifyour risk of getting HIV infections becomes low because of changes that occur in your life, you maywant to stop taking PrEP. If you find you don’t want to take a pill every day or often forget to take yourpills, other ways of protecting yoursel

Sections 12 Contains information relevant to administrative and billing codes for PrEP related services. Section 13 Contains potential practice quality practice measures. Section 14 Documents the methods used to develop the PHS PrEP Clinical Practice Guidelines.