Trends in STDs: US Perspective. Michael Towns, M.D. WW Vice President, Medical Affairs BD Diagnostic Systems

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Transcription:

Trends in STDs: US Perspective Michael Towns, M.D. WW Vice President, Medical Affairs BD Diagnostic Systems

Outline Overview of STD Epidemiology and Current Situation in US Overview of Chlamydia infections Screening Guidelines & Recommendations Efficacy of Screening Reimbursement for testing Conclusions

Overview of STD Epidemiology The Top 3 reportable STDs in the US (rank) 1. Chlamydia (estimated ~ 3 million new cases/yr) 2. Gonorrhea 3. Syphilis Co-infections also common (up to 30%)

Estimated Annual Burden and Cost of STD in the U.S. Estimated Annual Cases Estimated Annual Direct Cost (millions) Chlamydia 2.8 million $624 Gonorrhea 718,000 $173 Syphilis 70,000 $22 Hepatitis B * 82,000 $42 Genital Herpes 1.6 million $985 Trichomoniasis 7.4 million $179 HPV 6.2 million $5,200 HIV * 40,000 $8,100 18.9 million $15.3 billion * Costs of sexually-acquired cases only.

The Hidden Epidemic: An Urgent Reality Still With Us STDs are hidden epidemics of tremendous health and economic consequences in the U.S. They are hidden from public view because many Americans are reluctant to address sexual health issues in an open way and because of the biological ands social factors associated with these diseases. In addition, the scope, impact, and consequences of STDs are under-recognized by the public and health care professionals.

Chlamydia trachomatis Affects both men and women In men, predominately causes urethritis In women, predominately causes both urethritis and cervicitis (50%) with 25% urethritis or cervicitis alone The majority of those infected are asymptomatic (up to 75% of women!!) Disease can be easily diagnosed and cured If not detected, can lead to pelvic inflammatory disease (PID), infertility, and tubal pregnancies in women PID occurs in up to 40% of women who have untreated chlamydial infection Increases risk of HIV infection in both women and men

Chlamydia (cont) Is transmitted via sexual intercourse, as well as oral and anal sex Transmission is facilitated since majority are asymptomatic and don t know that they are infected Sexually active women younger than 25 yr old are at greatest risk of disease AND are at the greatest risk for complications as a result of undetected and untreated chlamydial infection 15 19 yo women account for ~50% of reported cases in US 20 24 yo women account for an additional 33% of cases CDC reports that 1 in 10 teenage girls in US are infected

Chlamydia Rates Among Females, 2006 3000 Cases per 100,000 population 2500 2000 1500 1000 500 0 14- Oct 15-19 20-24 25-29 30-34 35-39 40-44 45-54 55-64 65+ Age Group

Present Situation in US Chlamydia cases are increasing (apparently) Increase in Screening activities Use of more sensitive diagnostic tests Increased emphasis on reporting Improvements in use of information systems Possible true increases in prevalence, (but recent data suggests a decline)

Chlamydia Rates: Total and by sex: United States, 1987 2006 Rate (per 100,000 population) 600 480 Men Women Total 360 240 120 0 1987 89 91 93 95 97 99 2001 03 05 Note: As of January 2000, all 50 states and the District of Columbia had regulations requiring the reporting of chlamydia cases.

Chlamydia Rates by state: United States and outlying areas, 2006 Guam 494 283 283 263 234 279 348 206 376 350 406 510 682 435 286 339 309 285 331 366 252 283 396 297 395 365 363 420 317 651 425 503 350 214 430 160 525 318 387 275 318 357 175 VT 191 NH 152 MA 241 RI 292 CT 312 NJ 232 DE 429 MD 390 DC 612 Rate per 100,000 population <=150 150.1-300 >300 (n= 1) (n= 21) (n= 32) Puerto Rico 130 Virgin Is. 187 Note: The total rate of chlamydia for the United States and outlying areas (Guam, Puerto Rico and Virgin Islands) was 345.0 per 100,000 population.

Chlamydia Cases by reporting source and sex: United States, 1997 2006 Cases (in thousands) 750 600 non-std Clinic Male non-std Clinic Female STD Clinic Male STD Clinic Female 450 300 150 0 1997 98 99 2000 01 02 03 04 05 06

Chlamydia Median state-specific positivity among 15- to 24-year-old women tested in family planning clinics: United States, 1997 2006 Median state-specific positivity rate 10 8 6 4 2 0 1997 98 99 2000 01 02 03 04 05 06 Note: As of 1997, all 10 Health and Human Services (HHS) regions, representing all 50 states, the District of Columbia, and outlying areas, reported chlamydia positivity data. SOURCE: Regional Infertility Prevention Projects; Office of Population Affairs; Local and State STD Control Programs; Centers for Disease Control and Prevention

Chlamydia Positivity among 15- to 24-year-old women tested in family planning clinics by state: United States and outlying areas, 2006 6.5 6.0 4.6 6.4 6.3 5.0 11.3 6.4 6.7 7.3 9.7 5.8 8.6 8.2 6.9 5.9 6.1 7.2 10.3 6.7 6.2 7.1 6.2 8.1 7.6 7.9 7.1 7.9 14.0 6.5 14.5 5.6 7.8 10.3 2.8 11.5 5.5 4.9 7.8 7.8 4.6 4.4 Positivity (%) VT 3.9 NH 4.1 MA 4.7 RI 6.7 CT 5.7 NJ 7.5 DE 7.7 MD 5.7 DC 7.2 <5.0 5.0-9.9 >=10.0 (n= 8) (n= 38) (n= 7) Puerto Rico 6.4 Virgin Is. 16.9 Note: Includes states and outlying areas that reported chlamydia positivity data on at least 500 women aged 15-24 years screened during 2006. SOURCE: Regional Infertility Prevention Projects; Office of Population Affairs; Local and State STD Control Programs; Centers for Disease Control and Prevention

Chlamydia trachomatis infections continue to increase? or decrease? The correct answer is: DECREASE By how much? At this point in 2007 there were 816,774 cases As of October 14, 2008 800,658 cases

Gonorrhea Rates: United States, 1941 2006 and the Healthy People 2010 target Rate (per 100,000 population) 500 400 Gonorrhea 2010 Target 300 200 100 0 1941 46 51 56 61 66 71 76 81 86 91 96 2001 06 Note: The Healthy People 2010 target for gonorrhea is 19.0 cases per 100,000 population.

Gonorrhea Rates: Total and by sex: United States, 1987 2006 and the Healthy People 2010 target Rate (per 100,000 population) 400 320 Male Female Total 2010 Target 240 160 80 0 1987 89 91 93 95 97 99 2001 03 05 Note: The Healthy People 2010 target for gonorrhea is 19.0 cases per 100,000 population.

Gonorrhea Rates by state: United States and outlying areas, 2006 Guam 58.1 67.3 20.7 40.1 14.4 23.6 115.6 36.0 93.4 79.2 100.2 89.9 94.9 69.4 24.0 47.3 81.5 80.5 133.2 139.5 64.4 66.3 175.9 154.9 125.1 240.6 154.9 158.2 139.2 162.6 167.4 78.5 52.5 234.0 216.8 257.1 242.5 92.2 85.6 199.4 134.8 90.7 10.4 VT 11.6 NH 13.7 MA 38.0 RI 47.2 CT 74.4 NJ 63.0 DE 176.0 MD 130.8 DC 342.8 Rate per 100,000 population <=19.0 19.1-100.0 >100 (n= 5) (n= 27) (n= 22) Puerto Rico 7.7 Virgin Is. 31.3 Note: The total rate of gonorrhea for the United States and outlying areas (Guam, Puerto Rico and Virgin Islands) was 119.4 per 100,000 population. The Healthy People 2010 target is 19.0 cases per 100,000 population.

Untreated Chlamydia Infection 3-5 fold Increased Risk of HIV Up to 40% Pelvic Inflammatory Disease (PID) Neonatal Pneumonia & Conjunctivitis 17% Chronic Pelvic Pain 9% Ectopic Pregnancy 17% Infertility

CT and GC Control: A Tale of Two Infections Chlamydia Rates: Total and by sex: U.S., 1988 2007* Gonorrhea Rates by race/ethnicity: U.S., 1998 2007* Rate (per 100,000 population) 600 Men Women 480 Total Rate (per 100,000 population) 900 720 360 240 540 360 American Indian/AK Native Asian/Pacific Islander Black Hispanic White 120 180 0 0 1988 90 92 94 96 98 2000 02 04 06 1998 99 2000 01 02 03 04 05 06 07 Chlamydia Trends in positivity among 15- to 24- year-old women tested in family planning clinics by HHS region, 2002 2006 Pelvic inflammatory disease Hospitalizations of women 15 to 44 years of age: U.S., 1996 2005 6.7 7.5 7.7 7.4 7.5 02 03 04 05 06 8.2 8.7 8.8 9.0 9.2 02 03 04 05 06 6.1 5.5 5.4 5.5 5.5 02 03 04 05 06 Hospitalizations (in thousands) 75 Region X Region V Region I 60 8.0 8.5 8.5 8.1 8.6 02 03 04 05 06 Region IX 7.4 7.3 7.6 7.4 8.4 02 03 04 05 06 X IX VIII VII VI V IV III II I 9.1 10.2 9.7 7.8 7.5 02 03 04 05 06 Region II 6.8 6.9 7.5 7.4 6.7 02 03 04 05 06 45 30 Acute, Unspec. Chronic Region VIII Region III 15 6.5 6.5 6.8 6.8 7.6 11.8 11.7 11.7 11.5 11.3 10.1 9.6 10.9 11.0 11.0 0 02 03 04 05 06 Region VII 02 03 04 05 06 Region VI 02 03 04 05 06 Region IV 1996 97 98 99 2000 01 02 03 04 05 *Preliminary 2007 data

Chlamydia Age- and sex-specific rates: United States, 2006 Men Rate (per 100,000 population) Women 3000 2400 1800 1200 600 0 Age 0 600 1200 1800 2400 3000 11.6 10-14 121.5 545.1 15-19 2862.7 856.9 20-24 2797.0 480.8 25-29 1141.2 222.2 30-34 415.7 120.8 35-39 174.2 65.1 40-44 69.0 27.8 45-54 25.6 9.1 55-64 6.8 2.8 65+ 2.2 173.4 Total 517.0

Gonorrhea Age- and sex-specific rates: United States, 2006 Men Rate (per 100,000 population) Women 750 600 450 300 150 0 Age 0 150 300 450 600 750 6.3 10-14 35.1 279.1 15-19 647.9 454.1 20-24 605.7 320.9 25-29 294.9 185.7 30-34 125.5 130.8 35-39 65.7 93.5 40-44 33.9 53.0 45-54 12.9 18.4 55-64 2.9 4.2 65+ 0.7 117.1 Total 124.6

Screening Guidelines in US

US Preventive Services Task Force (USPSTF) Group that systematically reviews the evidence of effectiveness of a wide range of clinical preventive services Currently in the US, it is recommended that ALL sexually active women <25 yo should be screened routinely, as well as those 25 yo who have multiple sex partners Routine screening will reduce the risk of PID, as well as improve the health of those pregnant

Chlamydia Screening Recommendations Sexually active women 24 yo All sexually active women with new or multiple sexual partners Or Whose partners have had multiple partners within the past year, regardless of age Have a history of STD within the last year, regardless of age All pregnant women at least once, regardless of age Consider re-screening any infected woman, especially adolescents, 3-4 months after treatment, due to high incidence of re-infection

How effective is screening? According to the CDC, states that have chlamydia screening programs have infection rates that have been reduced by 67%! Results from a randomized clinical study (NEJM 1996) showed a reduction in cases of PID in those screened for chlamydia compared to no screening CDC estimates that for every $1 spent on screening, that $12 is saved in treatment costs

CT Screening Prevents PID: Clinical Trial, Seattle HMO, 1990-1992 Randomized controlled trial high-risk women, ages 18-34 yo 1009 assigned to intervention (invitation to get tested) 1598 assigned to usual care Among intervention group, 64% were tested, with 7% positive and treated Outcome of PID within 1 yr: 9 cases in screening group 33 cases in usual care group (RR=0.44) PID Rate (per 1000) 20 15 10 5 0 Usual Care Screened Scholes, et. al., NEJM 334:1362-6, 1996

Pelvic inflammatory disease Initial visits to physicians offices by women 15 to 44 years of age: United States, 1997 2006 Visits (in thousands) 300 240 180 120 60 0 1997 98 99 2000 01 02 03 04 05 06 Note: The relative standard error for these estimates ranges from 19% to 30%. SOURCE: National Disease and Therapeutic Index (IMS Health)

CT screening coverage, 1999-2006 (HEDIS): slowly but surely Chlamydia Screening: Ages 16-25 60 50 % 40 30 20 Commercial 16-20 Medicaid 16-20 Commercial 21-25 Medicaid 21-25 10 0 1999 2000 2001 2002 2003 2004 2005 2006

Estimated Chlamydia Screening Coverage (HEDIS), Females 16-26, U.S.A. and California, 1999-2006 100 1999 2000 2001 2002 2003 2004 2005 2006 90 80 70 Percent Screened 60 50 40 30 20 10 0 Natl MCO Natl Medicaid MediCal MC NCal HMO FPACT Source: California Chlamydia Action Coalition Report, 2005

Will health insurance pay for screening? STD testing is covered by most U.S. health insurance plans. Surveys of major health insurers indicate that preventive care services (including vaccination and testing) are increasingly covered for persons at risk, under plans with a preventive care component. - Health insurers report that specific risk factor data is not required for reimbursement; an assessment by a clinician that the preventive care service is medically indicated is usually sufficient. - Office billing staff may need training in appropriate codes that allow for reimbursement.

Partnerships to Expand CT Screening Highest ranking clinical preventive services with lowest utilization rates (% population coverage) (Masciosek MV. Am J Prev Med 2006) Tobacco-use interventions (35%) Colorectal cancer screening > 50 (35%) Pneumococcal immunization > 65 (56%) Screening sexually active women < 25 for CT annually (40%) Next steps with Partnership for Prevention CT Screening Implementation Guide National Coalition for CT Screening Steering Committee of 8 organizations Discussions with additional organizations ongoing Committees to focus on Public Awareness, Provider Education, Health Services Research, Advocacy Planning meeting in May

Getting the Word out: STD Prevention is Everyone s Business Given the high incidence of STD and nature of our prevention approaches, STD prevention is relevant for ALL segments of society, not just those traditionally considered at high-risk. ALL youth: need for better awareness of STD and prevention options ALL pre-teen and adolescent females: need for HPV vaccine ALL persons 13-65 yo: at least 1 HIV test ALL sexually active F < 26: CT screening ALL sexually active MSM: annual STD/HIV testing In short, now more than ever, STD prevention is EVERYONE s business. Comprehensive approach to STD prevention is a shared concern among a variety of stakeholders interested in the health of our young people public health (national, state, local), health care providers, parents, educators public Normalizing conversations and policies around STD prevention so that we deal with this topic as openly and normatively as we would concerns about obesity or pandemic influenza is CRITICAL if we are going to effectively engage this broad network of stakeholders.

Priorities for Infertility Prevention: CT & GC Control Chlamydia Expand screening of sexually active women < 26 public sector screening into potentially higher prevalence populations (e.g., schools, detention) private sector screening (enhanced promotion of guidelines, partnerships with health plans and professional organizations) Reduce re-infection (improved partner management, re-screening) Male screening (selected high-prevalence venues) Gonorrhea Maintain effective therapy Monitoring GC resistance Access to effective antibiotics a growing problem

Conclusions STDs are still a major problem in the US Chlamydia is the most frequently reported STD in the US The problem with Chlamydia is that the majority of infections are asymptomatic Therefore, screening programs are needed to detect these infections Screening offers the opportunity for detection of disease and subsequent treatment Screening leads to a decrease in PID and associated costs of treating the complications of undiagnosed chlamydial infections