UPDATE: GENITAL HERPES SIMPLEX VIRUS INFECTION Nick Van Wagoner, MD, PhD University of Alabama at Birmingham Webinar NICK VAN WAGONER: DISCLOSURES Will not discuss off-label use of commercial products and/or services No commercial interest or affiliations LEARNING OBJECTIVES BY THE END OF THE LECTURE: 1. Reviewed HSV-2 epidemiology in the U.S. 2. Understand the pathogenesis of HSV-2 3. Identify the clinical manifestations of HSV-2 4. Choose appropriate test(s) for HSV-2 diagnosis 5. Discuss the management of HSV-2 6. Introduce new research in HSV-2 prevention and treatment 1. 2. 3. 4. 5. 6. Genital Herpes is the most prevalent STD in the U.S. Life-long infection Sexually transmitted Most people don’t know their infected Viral shedding occurs in the absence of symptoms Transmission usually occurs when symptoms are absent EPIDEMIOLOGY GENITAL HSV IN THE U.S. HSV IS THE MOST PREVALENT STD IN THE US Over 1 million new genital herpes infections occur each year. Centers for Disease Control and Prevention: available at http:/www.cdc.gov Xu et al. JAMA. 2006: 296: 964-973 Leone, Update on Epidemiology and Treatment Strategies for Genital Herpes. 2008 SEROPREVALENCE OF HSV-2, NHANES, 20052008 Overall Seroprevalence: 16.2% Women: 20.9% Men: 11.9% MMWR. 2010.59(15):456 HSV RISK FACTORS Biology Gender Race Male Circumcision Age Sociodemographics Income Living conditions Sexual Networks Behavior No. of Partners Early Sexual Debut Drug Use XU et al., JAMA. 2006. 296: 964-973 Newman, STD. 2008. 35: S4-S12 UNKNOWN HSV-2 INFECTION Men Attending the JCHD HSV-2 Positive Know it HSV-2 Positive Don’t know it HSV-2 Negative ~80-90% of people that test positive for HSV-2 in the U.S are unaware that they are infected Xu et al. JAMA. 2006: 296: 964-973, MMWR. 2010.59(15):456 PATHOGENESIS VIROLOGY: HSV-1 AND HSV-2 Members of the human herpes virus family (herpetoviridae). Genome: ~154,000 bp DS DNA HSV-1 and HSV-2 50% Identical Todar. Ken Todar’s Microbial World. U of Wisconsin. 2006 HSV-2 causes about ½ of genital ulcers The other ½ are caused by HSV-1 Dwyer and Cunningham. MJA 2002 177(5): 267-273 Asymptomatic Infection Gupta et al., Lancet 2007 HSV GENITAL/ANOGENITAL TRANSMISSION Sexual Receptive Vaginal--Insertive Vaginal Receptive Anal--Insertive Anal Receptive Oral (HSV-1) Efficiency of sexual transmission: greater from men to women Likelihood of transmission declines with duration of infection DEFINITIONS OF FIRST CLINICAL EPISODES Primary infection First infection ever (HSV-1 or HSV-2) More severe No antibody present when symptoms appear Non-primary New HSV-1 or HSV-2 in an individual previously seropositive to the other virus infection Will have antibody to the other HSV virus when symptoms appear Symptoms usually milder than primary infection FIRST EPISODE PRIMARY INFECTION Characteristics of Lesions: Usually multiple and bilateral More severe than recurrences Contain higher virus titers than in recurrence Last 11-12 days and shed virus for ~12 days Local symptoms include pain, itching, dysuria, vaginal or urethral discharge, and tender inguinal adenopathy ○ Cervicitis is common Systemic Symptoms Last 2-4 weeks Fever, headache, malaise, myalgias RECURRENT SYMPTOMATIC INFECTION Disease is milder and shorter in duration Antibody to HSV-2 present Prodromal Lesions No last 5-10 days systemic symptoms HSV-2 is more prone to recur than HSV-1 HSV LESION PROGRESSION Papule Vesicle Pustule Ulcer Crust A circumscribed elevated, sollid lesion, less than 1 cm A circumscribed, serous ,fluid filled elevation of the skin, less than 0.5 cm A small (< 1 cm in diameter), circumscribed superficial elevation of the skin that is filled with purulent material. A localized defect in the skin of irregular size and shape where epidermis and some dermis have been lost. Varying colors of liquid debris (serum or pus) that has dried on the surface of the skin Images /Definitions from: missinglink.ucsf.edu/ (2009) living with herpes.net (2009) Cincinnati STD/HIV Prevention Training Center Herpes Doesn’t Read Textbooks HSV LESION PROGRESSION Papule Vesicle A circumscribed elevated, sollid lesion, less than 1 cm A circumscribed, serous ,fluid filled elevation of the skin, less than 0.5 cm Lesions Pustule Ulcer A small (< 1 cm in A localized defect in diameter), the skin of irregular circumscribed size and shape superficial elevation where epidermis and of the skin that is some dermis have Canfilled Have Many Appearances with purulent been lost. material. Crust Varying colors of liquid debris (serum or pus) that has dried on the surface of the skin Images /Definitions from: missinglink.ucsf.edu/ (2009) living with herpes.net (2009) Cincinnati STD/HIV Prevention Training Center Asymptomatic Infection Asymptomatic But Gupta etShedding al., LancetHSV-2 2007 Gupta et al., Lancet 2007 ASYMPTOMATIC VIRAL SHEDDING No genital lesions present Between clinical outbreaks No history of clinical outbreaks Antibody present Common sites Women: vulva and perianal region Men: penile skin and perianal region Greatest in the first 3 months but continues Asymptomatic shedding is of briefer than during clinical recurrences VIRAL SHEDDING OCCURS IN THE ABSENCE OF SYMPTOMS Mark et al, 2008. JID 198: 1141-9 TRANSMISSION USUALLY OCCURS WHEN SYMPTOMS ARE ABSENT 144 discordant couples followed over time Median 334 Days 14 of 144 partners were infected (9.7%) 70% of transmission occurred when the index case was asymptomatic Mertz et al. 1992. Risk Factors for the Sexual Transmission of Genital Herpes. Ann Intern Med. 116(3) CLINICAL MANIFESTATIONS Clinical Manifestations HERPES: PRIMARY COMPLEX papules vesicles pustules ulcers crusts healed Source: Cincinnati STD/HIV Prevention Training Center Clinical Manifestations HERPESpapules : GENITALIS MULTIPLE ULCER vesicles pustules ulcers crusts healed Source: Cincinnati STD/HIV Prevention Training Center Clinical Manifestations HERPES: GENITALIS EXTERNALLABIA MINOR papules vesicles pustules ulcers crusts healed Source: Cincinnati STD/HIV Prevention Training Center HERPES: GENITALIS CLINICAL Clinical Manifestations PERIURETHAL LESIONS ON VESTIBULE papules vesicles pustules ulcers crusts healed Source: Cincinnati STD/HIV Prevention Training Center Clinical Manifestations HERPES: CERVICITIS papules vesicles pustules ulcers crusts healed Source: Cincinnati STD/HIV Prevention Training Center Clinical Manifestations HERPES ON THE BUTTOCK papules vesicles pustules ulcers crusts healed Source: Cincinnati STD/HIV Prevention Training Center HSV DIAGNOSIS Clinical diagnosis is insensitive and nonspecific Clinical diagnosis should be confirmed by lab testing Virologic Two types Serologic VIROLOGIC TESTS Viral culture (gold standard) Preferred test for patients with genital ulcers or other mucocutaneous lesions ○ ○ Most sensitive when lesions are in the vesicular-pustular stage Sensitivity rapidly declines as lesions ulcerate and crust Nucleic Acid Amplification User Friendly More Sensitive TYPE-SPECIFIC SEROLOGIC TESTS Type-specific and nonspecific antibodies to HSV develop during the first several weeks following infection and persist indefinitely Presence of HSV-2 antibody indicates anogenital infection Presence of HSV-1 does not distinguish anogenital from orolabial infection. Lab-Based Serology Tests % Sensitivity (95% CI) % Specificity (95% CI) HerpesSelect HSV-1 ELISA 91 (85-95) 92 (85-97) HerpeSelect HSV-2 ELISA 96 (89-99) 97 (93-99) HerpeSelect HSV-1 Immunoblot IgG 99 (96-100) 95 (89-98) HerpeSelect HSV-2 Immunoblot IgG 97 (91-100) 98 (95-100) Captia HSV-1 ELISA 88 (82-94) 100 (96-100) Captia HSV-2 ELISA 97 (89-100) 90 (84-95) HerpeSelect Express Rapid HSV-2 IgG 98 (95-99) (Capillary whole blood) 99 (97-100) (Capillary whole blood) Biokit HSV-2 Rapid Test Sure-Vue HSV-2 Rapid Tests 92 (91-94) (Capillary whole blood) 87 (85-89) (Capillary whole blood) Point-of-Care Serology From: The HERPES Testing Toolkit: A clinician’s guide to serologic testing for Herpes simlex virus (HSV). ASHA DIAGNOSIS Infection Type Lesions/ Symptoms Type-specific antibody at time of presentation HSV-1 HSV-2 First episode, Primary (Type 1 or 2) +/Severe, bilateral - - First episode, Non-primary Type 2 +/Moderate + - First episode, Recurrence Type 2 +/Mild +/- + Symptomatic, Recurrence Type 2 +/Mild, unilateral +/- + Asymptomatic, Infection Type 2 - +/- + CANDIDATE PATIENTS FOR TYPE-SPECIFIC GENITAL HERPES TESTS Testing Recommended Typical Genital Lesion Swab Test (Viral Culture or PCR) Serological Test (Type Specific Ab) X X Clinical dx with negative or no swab test Atypical Lesion (e.g, fissure, erythema) X X X Recurrent lower genital tract inflammation with no lesions (e.g, dysuria, burning, itching) X STI evaluation, no lesions X Sexually active patient requests test, no lesion X Sex partner of patient with genital herpes X Experts disagree on whether or not these patients should be tested HIV, no lesion X Sexual assault, no lesion X Pregnancy, no lesions X High risk populations (e.g. MSM), no X lesions From: The HERPES Testing Toolkit: A clinician’s guide to serologic testing for Herpes simlex virus (HSV). ASHA PATIENT MANAGEMENT PRINCIPLES OF MANAGEMENT OF GENITAL HERPES Systemic antiviral chemotherapy Partially controls symptoms and signs of herpes episodes Does not eradicate latent virus Does not affect risk, frequency or severity of recurrences after drug is discontinued Counseling Natural history Sexual transmission Perinatal transmission Methods to reduce transmission Management ANTIVIRAL MEDICATIONS Systemic antiviral chemotherapy includes 3 oral medications: Acyclovir Valacyclovir Famciclovir Topical antiviral treatment has minimal clinical benefit and is not recommended. FIRST CLINICAL EPISODE START EARLY AND TREAT LONGER 2010 STD Treatment Guideline 2010 EPISODIC TREATMENT FOR RECURRENT GENITAL HERPES Therapy should be initiated within one day of symptoms Patients can be given prescriptions ahead of time SUPPRESSIVE THERAPY FOR RECURRENT GENITAL HERPES Reduces frequency of recurrences Reduces but does not eliminate subclinical viral shedding Periodically (e.g., once a year), reassess need for continued suppressive therapy. SPECIAL POPULATIONS Percent HVS-2 Positive HIV AND HSV-2 COINFECTION IS COMMON Modifed from Russel et al. J of Clin Vir. 2001. 22: 305; and Wald and Celum. Medscape CE course 2005: www.medscape.com HSV AND HIV ARE LINKED Effect of HIV on HSV2 Alters the clinical presentation of HSV-2 Increased HSV-2 shedding Larger, slowerhealing lesions in persons with advanced HIV Increased risk of HSV-2 acquisition Effect of HSV-2 on HIV Increases risk of HIV acquisition/ transmission HSV HIV Genital Lesions provide a portal of entry for HIV Increased number of activated CD4+ and CD8+ T cells in genital mucosa and skin Increased HIV levels in plasma and genital tract Leone, Update on Epidemiology and Treatment Strategies for Genital Herpes. 2008 CDC-RECOMMENDED REGIMENS FOR EPISODIC INFECTION IN HIV-INFECTED PERSONS TREAT LONGER CDC-RECOMMENDED REGIMENS FOR DAILY SUPPRESSIVE THERAPY IN HIV-INFECTED PERSONS HERPES IN PREGNANCY (NEONATAL HERPES) Most commonly transmitted during delivery Greater risk to infant if mother has primary genital lesions Primary genital lesions = 40-50% of infants affected Recurrent genital lesions = 2-3% Risk of transmission 1 in 3,000-20,000 live births Affects ~1,500-2,000 infants/yr in US Young maternal age Maternal seronegativity Presence of vaginal lesions during delivery Infant prematurity Manifests during first 4 weeks after birth HERPES IN PREGNANCY (NEONATAL HERPES) Neonatal Herpes Syndromes Skin, eye and mouth (SEM) Typically lesions are on the scalp, mouth, nose, and eye (where the skin comes in contact with the mother’s genital lesions) CNS (Seizures, lethargy, and hypotonia) Accounts for ~60% of cases. May have skin lesions 40% of survivors may have neurological deficits Disseminated (including liver, adrenal glands, lungs) Devastating 50% mortality Present with shock (multi-organ system failure) HERPES IN PREGNANCY (CONTINUED) Prevention of neonatal herpes depends on avoiding acquisition of HSV during late pregnancy and avoiding exposure of the infant to herpetic lesions during delivery. HERPES IN PREGNANCY (CONTINUED) Ask all pregnant women if they have a history of genital herpes. At the onset of labor: Question all women about symptoms of genital herpes, including prodrome. Examine all women for herpetic lesions. Women without symptoms or signs of genital herpes or its prodrome can deliver vaginally. HERPES IN PREGNANCY (CONTINUED) Treatment in Pregnancy Oral Acyclovir may be administered to pregnant women with first-episode genital herpes or recurrent herpes IV Acyclovir may be administered to pregnant women with severe HSV infection No increased risk of birth defects in women treated with acyclovir during 1st trimester More limited data for valacyclovir and famciclovir LESSON VI: PREVENTION PATIENT COUNSELING AND EDUCATION Goals Help patients cope with the infection Physical and Psychological Aspects Prevent sexual and perinatal transmission Education is an ongoing process Nature of the infection Transmission Treatment Options Risk-reduction Partner Management NATURE OF THE INFECTION Sexual transmission of HSV can occur during asymptomatic periods. Stressful events may trigger recurrences. Prodromal symptoms may precede outbreaks. TRANSMISSION Abstain from sexual activity with uninfected partners when lesions or prodromal symptoms are present. Inform current sex partners. Inform future sex partners before initiating sex. TREATMENT OPTIONS Discuss: Effectiveness of suppressive and episodic therapy to prevent or shorten the duration of recurrent episodes When and how to take antiretroviral medications Recognition of prodromal symptoms Treatment is not curative RISK REDUCTION Assess client's behavior-change potential. Discuss prevention strategies (abstinence, mutual monogamy with an uninfected partner, condoms, limiting number of sex partners, etc.). Work with patient to develop individualized riskreduction plans. COUNSELING FOR ASYMPTOMATIC PERSONS Asymptomatic HSV-2 infected persons should receive the same counseling messages as symptomatic persons. Teach the common manifestations of genital herpes PARTNER MANAGEMENT Symptomatic sex partners Evaluate and treat in the same manner as patients who have genital lesions. Asymptomatic sex partners Ask about history of genital lesions. Educate to recognize symptoms of herpes. Offer type-specific serologic testing. THE FUTURE OF HSV-2 (VACCINATION AND MICROBICIDES) HOPE FOR A VACCINE Johnston et al. 2011. JCI. 121(12): 4600 HOPE FOR A VACCINE Johnston et al. 2011. JCI. 121(12): 4600 Belshe et al. 2012. NEJM Johnston et al. 2011. JCI. 121(12): 4600 THERAPEUTIC VACCINES FOR HSV-2 Johnston et al. 2011. JCI. 121(12): 4600 TENOFOVIR MICROBIDICE: HIV AND HSV-2 PREVENTION HIV 51% Reduction in HSV-2 Acquisition in women using the Tenofovir Gel Karim et al. 2010. Science. 329:1168 NEW THERAPEUTICS Still Searching… LEARNING OBJECTIVES BY THE END OF THE LECTURE: 1. Reviewed HSV-2 epidemiology in the U.S. 2. Understand the pathogenesis of HSV-2 3. Identify the clinical manifestations of HSV-2 4. Choose appropriate test(s) for HSV-2 diagnosis 5. Discuss the management of HSV-2 6. Introduce new research in HSV-2 prevention and treatment