Biomedical / Medical / Treatment Update - December 3, 2014

Transcription

1 Biomedical / Medical / Treatment Update - December 3, 2014 Jeffrey Beal, MD, AAHIVS Medical Director, HIV/AIDS Section Florida Department of Health Paul Arons, MD Medical Consultant, HIV/AIDS Section Florida Department of Health

2 The Epidemic in Florida Population in 2013: 19.3 million à (4 th in the nation) Newly diagnosed** HIV infections in 2013: 4,864 (2 nd in the nation in 2011) Newly diagnosed** AIDS cases in 2013: 2,532 (3 rd in the nation in 2011) Cumulative pediatric AIDS cases reported through 2013: 1,547 (2 nd in the nation in 2011) Persons diagnosed and living*** with HIV disease through 2013: 106,335à (3rd in the nation in 2010) HIV prevalence estimate through 2013: 126,000 (11.4% of the U.S. estimate for 2010) 57% White 15% Black 24% Hispanic 4% Other* 29% White 49% Black 20% Hispanic 2% Other* HIV Incidence Estimates in 2012: 4,056 (There was a 19% decrease from ) HIV-related deaths in 2013: 935 (Up 1.3% from 2012) *Other = Asian/Pacific Islanders; American Indians/Alaskan Natives; multi-racial. **Data by year of diagnosis for 2013 are incomplete and should be interpreted with care *** Living (prevalence) data as of 06/30/2014

3 The Epidemic in Florida Population in 2013: 19.3 million à (4 th in the nation) Newly diagnosed** HIV infections in 2013: 4,864 (2 nd in the nation in 2011) Newly diagnosed** AIDS cases in 2013: 2,532 (3 rd in the nation in 2011) Cumulative pediatric AIDS cases reported through 2013: 1,547 (2 nd in the nation in 2011) Persons diagnosed and living*** with HIV disease through 2013: 106,335à (3rd in the nation in 2010) HIV prevalence estimate through 2013: 126,000 (11.4% of the U.S. estimate for 2010) HIV Incidence Estimates in 2012: 4,056 (There was a 19% decrease from ) HIV-related deaths in 2013: 935 (Up 1.3% from 2012) *Other = Asian/Pacific Islanders; American Indians/Alaskan Natives; multi-racial. **Data by year of diagnosis for 2013 are incomplete and should be interpreted with care *** Living (prevalence) data as of 06/30/2014; Source: 57% White 15% Black 24% Hispanic 4% Other* 29% White 49% Black 20% Hispanic 2% Other*

4 HIV Infection Cases and Rates*, by Year of Report, , Florida Number of Cases 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1, ,719 6,954 6,684 6,867 7,853 5,557 4,913 5,044 4,531 5, Year of Report Year Rate Note: Enhanced laboratory reporting (ELR) laws in 2006 and the expansion of ELR in 2007 led to an artificial peak in newly reported cases of HIV infection in This was followed by a general decline in reported cases through Another surge in the expansion of ELR in 2012 was followed by another increase in newly reported cases of HIV infection in These trends were observed across most race/sex/risk groups throughout the state. *Source: Population estimates are provided by Florida CHARTS as of 06/03/2014.

5 A Preliminary Analyses of HIV Infection Cases Diagnosed January-September 2013 and 2014 Data * Overall larger increases among whites and Hispanics, and a very small increase among blacks; the proportion of black is decreasing annually compared to other races * Increases among males of all races * Decreases among black females * Large increases among MSM and MSM/IDU * Some increase among IDU * Decreases among heterosexuals HIV/AIDS Section, Surveillance Program, December 2014

6 FLORIDA HIV Infections * January through 11/30/ * January through 11/30/ (25% increase) * January through 11/30/ (11% increase) AIDS Cases * January through 11/30/ * January through 11/30/ (24% increase) * January through 11/30/ (16% decrease) NOTE: The decrease in AIDS cases following last year s large increase is encouraging, although NOT ALL counties have a YTD decrease. HIV/AIDS Section, Surveillance Program, December 2014

7 HIV Infected Births in Florida * There are now 10 known HIV-infected births born in Florida for 2013 * 4 were diagnosed with AIDS in These are the first AIDS babies under age 2 since * For known HIV-infected birth born in Florida * one from Escambia County * one from Orange County * one from Miami-Dade County * one from West Palm Beach County HIV/AIDS Section, Surveillance Program

8 Proportion of Adult HIV Infection Cases, by Sex and Year of Report Florida Proportion of Cases Male Female M:F Ratio : : Year of Report Note: In 2013, 77% of the adult HIV infection cases were male, compared to only 70% in Over the past ten years, the proportion of HIV infection cases among men has increased while the proportion among women has decreased. The result is an increase in the male-to-female ratio, from 2.3:1 in 2004 to 3.3:1 in The relative increase in male HIV cases might be attributed to proportional increases in HIV transmission among men who have sex with men (MSM). Source: _documents/hiv-aids-slide%20sets/state-trends pdf

9 Adult HIV Infection Cases, by Race/Ethnicity, and Year of Report Florida White Black Hispanic Other* Number of Cases Year of Report Note: Over the past ten years, HIV infection cases decreased among blacks by 32% and among whites by 21%. There was a 1% overall increase among Hispanics for this same period. *Other includes American Indian/Alaska Native, Asian/Pacific Islander, and multi-racial. Source:

10 Adult HIV Infection Cases by Mode of Exposure, Reported in the United States* and Florida U.S. (2011) N=49,081 Florida (2013) N=5,916 8% 3% 27% <1% MSM IDU 34% <1% MSM/IDU 2% Heterosexual Other 5% 62% 59% Note: NIRs redistributed. Similar to the AIDS data, the estimated proportion of reported MSM cases for the US is higher than that of Florida (62% vs. 59% respectively). Also, the proportion of IDU cases are higher in the U.S. (8% vs. 5%) and heterosexual cases are lower (27% vs. 34%) when compared to HIV Infection cases reported in Florida. *Source: US data, CDC HIV surveillance report, Vol. 23, Table 1a, (from all 50 states) 2012 data not available.

11 Proportion of Cases Adult HIV Infection Cases, by Age Group at Diagnosis, and Year of Report Florida Year of Report Over the past ten years, the proportion of newly reported adult HIV cases has shown increases for both the (7 percentage points) and 50+ (7 percentage points) age groups. In contrast, the proportion of newly reported adult HIV cases among those in the and age groups decreased by 10 and 4 percentage points respectively, over the same time period. Source: state-trends pdf

12 HIV Treatment Cascade Treatment Cascades or Continuums Visualize: * Number diagnosed with HIV * Number linked to care * Number retained in care * Number of people on HIV therapy * Number achieving an undetectable viral load resources/policies/care- continuum

13 Treatment Cascade Targets Set by UNAIDS * Diagnose 90% of people with HIV * Treat 90% of those diagnosed * 90% treated to have undetectable VL with-undetectable-viral-load/page/ /

14 Raymond A et al. Large disparities in HIV treatment cascades between eight European and high-income countries: analysis of break points. International Congress of Drug Therapy in HIV Infection, abstract 0-237, Glasgow, 2014.

15 Number and Percentage of HIV Diagnosed Persons Florida (incl. DOC), 2013 * Recent 2011 CDC data shows 1.2 million people living with HIV in the US. Source:

16 Number and Percentage of HIV-Diagnosed Persons Engaged in Selected Stages of The Continuum of HIV Care Florida (incl. DOC), 2013 Linkage to Care * Recent 2011 CDC data shows 40% linked to HIV care in US Source:

17 Number and Percentage of HIV-Diagnosed Persons Engaged in Selected Stages of The Continuum of HIV Care Florida (incl. DOC), 2013 In Care Source:

18 Number and Percentage of HIV-Diagnosed Persons Engaged in Selected Stages of The Continuum of HIV Care Florida (incl. DOC), 2013 On ART * Recent 2011 CDC data shows 37% on ART in US Source:

19 Number and Percentage of HIV-Diagnosed Persons Engaged in Selected Stages of The Continuum of HIV Care Florida (incl. DOC), 2013 On ART and Undetectable Percent of Cases 100% 80% 60% 40% 20% 0% 106, % 91,193 86% 86% of those diagnosed with HIV were linked to care. HIV-infected = 126,289 58,820 55% 65% of those linked to care were in care this year. 53,291 50% 91% of those in care this year were on ART. 41,567 39% 78% of those on ART have a suppressed VL. (1) HIV Diagnosed (2) Linked to Care (3) In Care this Year (4) On ART (5) Suppressed Viral Load (<200 copies/ml on ART) * Recent 2011 CDC data shows 30% with viral suppression in US Source:

20 Impact of STIs on HIV Infection q Early detection and treatment of Sexually Transmitted Infections (STIs) has a major impact on sexual transmission of HIV. q STDs increase HIV infectivity and susceptibility. Source: Division of Disease Control, HIV/AIDS Section, Medical

21 Cases 90,000 80,000 70,000 60,000 50,000 40,000 30,000 20,000 10,000 0 Chlamydia, Gonorrhea, Syphilis* and HIV Cases, Reported , Florida Chlamydia Gonorrhea Syphilis HIV Year of Report * Note: Syphilis data include both Primary and Secondary Syphilis. Source: STD data validated through Florida CHARTS as of 4/18/2014. FloridaCHARTS.com is provided by the Florida Department of Health, Division of Public Health Statistics and Performance Management data is provisional as of 4/15/2014.

22 Florida Syphilis 5-Year Trends July 2014, 3 Day Intensive STD/HIV Training 22

23 HIV NEWS UPDATE

24 2014 New FDA Approvals * Triumeq = ABC/3TC/DTG * Vitekta = elvitegravir * Once daily 85 mg + ATV (300 mg)/rtv (100 mg) once daily OR LPV (400 mg)/rtv (100 mg) BID * Once daily 150 mg + DRV (600 mg)/rtv (100 mg) BID OR FPV (700 mg)/rtv (100 mg) BID OR TPV (500 mg)/rtv (200 mg) BID

25 2014 New FDA Approvals Cobicistat (Tybost ) * Pharmacokinetic enhancer - boosts other medications * Recommended dosage for Tybost - 150mg tablet once daily combined with: * Atazanavir (Reyataz ) 300 mg once daily * Darunavir (Prezista) 800 mg once daily * Must be coadministered with atazanavir (300mg once daily) or darunavir (800mg once daily) at the same time, with food * Assess estimated creatinine clearance at baseline and if on TDF assess urine glucose and protein at baseline as well Source: and TheBodyPRO.com. It is a part of the publication The 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2014).

26 New NNRTI on Horizon Doravirine (next generational NNRTI) vs Efavirenz * Treatment naïve patients * NRTI backbone is tenofovir/emtricitabine * Doravirine 100 mg dose * Remains active against HIV with common NNRTI mutations including K103N and Y181C * Fewer central nervous system (CNS) side effects * Viral suppression similar to efavirenz in study * Phase 3 to begin: doravirine vs DRV/r Gatell M et al. 48-week efficacy and safety and early CNS tolerability of doravirine (MK-1439), a novel NNRTI, with TDF/ FTC in ART-naive HIV-positive patients. International Congress of Drug Therapy in HIV Infection, Glasgow, abstract O434, 2014.

27 Dolutegravir (Integrase Inhibitor) * 1 st line treatment with ARV therapy containing dolutegravir (Tivicay ) * Superior to ritonavir boosted protease inhibitor darunavir (Prezista ) from studies * At week 96, 80% of patients taking dolutegravir had VL < 50copies/ml versus 68% of patients taking darunavir * Dolutegravir 50mg once a day remained superior to darunavir/ ritonavir 800/100mg once a day maintaining a good safety profile Molina J-M et al. Once-daily dolutegravir is superior to once-daily darunavir/ritonavir in treatment-naïve HIV-1- infected individuals: 96-week results from FLAMINGO (ING114915). J Int AIDS Soc 17 (3): 6 (abstract 0153), 2014

28 Restoring and Maintaining High CD4 Count * French study showed vast majority of people living with HIV on treatment since 2000 achieve CD4 count in normal range * Italian study showed achieving normal CD4 count while on treatment greatly reduced risk of cancer and serious non-aids illnesses Costagliola D et al. CD4+ cell count recovery in naïve patients initiating ART, who achieved and maintained plasma HIV-RNA suppression. J Int AIDS Soc 17 (3): 2 (abstract 0113), 2014.

29 DISCUSSION

30 Pre-Exposure Prophylaxis (PrEP)

31 WHAT IS PrEP? Start :46 End 2:59

32 In All PrEP RCTs PrEP is part of a comprehensive HIV prevention package, including: Comprehensive baseline assessment Counseling STD testing and treatment Condoms / lube In some cases, referral for circumcision Every 3 month f/u HIV/STI, risk reduction

33 PrEP Efficacy and Drug Detection

34 Increased PrEP Prescriptions in US * The US Food and Drug Administration (FDA) approved once-daily Truvada for PrEP in July * Centers for Disease Control and Prevention (CDC) recommended people at substantial risk should consider PrEP to prevent HIV infection. * World Health Organization (WHO) has also recommended PrEP as an option for at-risk gay men. * Truvada PrEP use rising in United States, especially among men * Uptake of Truvada PrEP has not been as widespread as many hoped. Flash C et al. Two years of Truvada for pre-exposure prophylaxis utilization in the US. International Congress of Drug Therapy in HIV Infection, abstract P198, Glasgow, 2014.

35 CDC Guidance for PrEP Prescribing: TIMELINE January 2011: PrEP for MSM August 2012: PrEP for Heterosexually Active Adults June 2013: PrEP for Injecting Drug Users CDC. MMWR 2011;60: CDC MMWR 2012;61:

36 High Efficacy Halts IPERGAY and PROUD Studies in 2014 IPERGAY: MSM 6 sites France/1-Canada; Placebo vs Truvada * 2 pills 12 hours before anticipated sex then one pill daily times two doses * Significant difference between placebo and tx arm PROUD study (immediate PrEP vs. 12 month delay) ended early as well switching all MSM and transgender women to daily Truvada All participants in both trials received: risk reduction, regular HIV/STI screens, condoms, Hep B screen/vaccine /

37 Factors to Help Identify Individuals at High Risk Is partner known to be HIV-1 infected, or engages in sexual activity within a high prevalence area or social network and one or more of the following: Inconsistent or no condom use Diagnosis of sexually transmitted infections Exchange of sex for commodities (such as money, shelter, food, or drugs) Use of illicit drugs or alcohol dependence Incarceration Partner(s) of unknown HIV-1 status with any of the factors listed above CDC. MMWR 2011;60: CDC MMWR 2012;61:

38 PrEP for Heterosexually Active Men and Women * Serodiscordant couples * In ongoing sexual relationship with an HIV-positive partner * Man who has sex with both women and men * Infrequently uses condoms during sex with one or more partners of unknown HIV * HIV-negative women who wish to become pregnant with male HIV-positive partner Pre-exposure Prophylaxis for the Prevention of HIV Infection in the United States 2014 Clinical Practice Guidelines

39 Source: Division of Disease Control, HIV/AIDS Section, Medical

40 PrEP Development - PrEPline * Clinical Consultation Center implemented a PrEPline * Provides expert guidance to US-based clinicians in identifying appropriate patients for PrEP * Informs on prevention measures, administration of PrEP medications, protocols and best practices * PrEPline :00a.m. 6:00p.m. EST Clinical ConsultationCenter PrEPline the- ccc- prepline

41 Future PrEP Injectable cabotegravir (INSTI) every 3 months Injectable rilpivirine? Vaginal and rectal gels

42 QUESTIONS?

43 HIV/AIDS Section Division of Disease Control and Health Protection Bureau of Communicable Diseases Florida Department of Health Jeffrey A. Beal, MD, AAHIVS, Medical Director Phone: Paul Arons, MD, Medical Consultant Phone: Debra L. Taylor, RN, MPA, ASQ-CQIA, Registered Nurse Consultant Phone: Roxanne Sieks, RN, CARN, Registered Nurse Consultant Phone: , Ext Annie Farlin, IOM, Administrative Assistant Phone: , Ext. 2514