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Characteristics of Native Americans with HIV and implications for care Christina Connel, PharmD, BCPS, Jeffrey S. Stroup, PharmD, BCPS, Johnny R. Stephens, PharmD, and Erica Martin, PharmD, BCPS Limited data have been published about HIV infections and response to antiretroviral therapy in the Native American population. We reviewed baseline characteristics of 112 Native American patients to determine if there were any shared characteristics that would dictate the best treatment for this population. Metabolic diseases and psychiatric disorders were common findings among our patients. Native American patients should be monitored and screened as appropriate for comorbid conditions, and these disease states should be considered when choosing an antiretroviral regimen. IV rates vary across ethnic groups in the United States. Data from 2009 estimated that approximately 3000 Native Americans were living with an HIV diagnosis in the United States (1). While Native Americans represent <1% of persons living with HIV, the rates of diagnosis increased in this population from 2007 to 2010 (1). In 2010, the estimated rates of HIV per 100,000 population of Native Americans was 9.7, which is higher than that for Asian or Caucasian populations, although lower than that for African American or Hispanic populations (1). HIV has not been well studied in the Native American population, leading to limited data for treatment specific to this group. The present study assessed the baseline characteristics and treatment of patients with HIV and Native American heritage. Our goal was to determine if there were any common variables among this population that would dictate the best treatment options for them. This study was conducted at a Ryan White clinic that cares for approximately 1100 HIV-positive patients. H METHODS This retrospective study evaluated the baseline characteristics of HIV-positive Native American patients >17 years of age at their initial visit to the Oklahoma State University Internal Medicine Specialty Clinic. Native American heritage was defined as either patient-reported ethnicity or a record of medical care through Indian Health Services. Data collected included patients’ age at transmission, gender, HIV genotype, baseline CD4 count and viral load, renal function, home medications (including antiretroviral therapy regimen), comorbid conditions, and mode of Proc (Bayl Univ Med Cent) 2014;27(2):103–105 transmission of HIV. Use of the clinic electronic medical record identified 149 patient charts meeting inclusion criteria for the study. Upon review, 21 patients had incomplete initial documentation, and 16 did not have documentation of Native American heritage. These charts were excluded, and 112 charts were reviewed for baseline characteristic data. Descriptive statistics of the patient population were used to analyze the data gathered. RESULTS Patients’ baseline characteristics at the first visit are shown in Table 1. Viral loads and CD4 counts of patients already controlled on antiretroviral therapy are not reported. Twenty-seven patients (24%) entered care with a diagnosis of AIDS based on a CD4 cell count <200/μL at the time of entry; however, previous AIDS-defining illnesses were not assessed in this study. Most patients (83%) were men, and the average age of diagnosis was 33 years. Ages of transmission ranged from birth to 65 years. One patient had vertical transmission and the other 111 patients received a diagnosis of HIV at the age of 18 or older. As shown in the Figure, the most frequent mode of transmission was men having sex with men, followed by heterosexual intercourse. Two patients reported intravenous drug use in addition to sexual activity as a possible mode for acquisition of HIV. Those reporting heterosexual intercourse as the form of transmission were more likely to be female. Thirty-five patients (31%) entered the clinic already on antiretroviral therapy; 20 of them had an undetectable viral load at entry into care. Eleven patients were continued on regimens despite evidence of undetectable viral loads, two did not have viral load recorded, and four had a viral load <500 copies/mL. Baseline HIV genotypes were collected when available. Unfortunately, only nine patients (8%) had resistance From the Department of Pharmacy Services (Connel, Martin) and the Department of Medicine (Stroup, Stephens), Oklahoma State University Medical Center, Tulsa, Oklahoma. Corresponding author: Jeffrey S. Stroup, PharmD, Chief Pharmacy Officer, Oklahoma State University Medical Center, Associate Professor of Medicine, Oklahoma State University Center for Health Sciences, 717 S. Houston Avenue, 3rd Floor, Tulsa, OK 74127 (e-mail: [email protected]). 103 Table 1. Baseline demographics in 112 Native American HIV-positive patients Variable Table 2. Comorbid conditions in 112 Native American HIV-positive patients Mean (range) Comorbid condition n (%) Age at diagnosis (years) 33 (0–65) Psychiatric disorder 34 (30%) Men 93 (83%) Viral load (copies/mL) CD4 (cells/μL) Serum creatinine (mg/dL) 137,807 (43–750,000) 374 (2–1142) 0.95 (0.61–1.51) Height (cm) 175 (150–198) Weight (kg) 80 (45–182) Depression 24 (71%) Anxiety 18 (53%) Bipolar disorder 2 (6%) Schizophrenia 1 (3%) Attention deficit hyperactive disorder 17 (15%) Dyslipidemia 17 (15%) Diabetes mellitus profiles at baseline. Six patients, all of whom were treatment naive, were sensitive to all antiretroviral agents, while three were resistant to at least one agent. Of the three, one was treatment naive with conferred resistance to lamivudine. The other two patients reported having previously been on therapy, and genotyping showed resistance to nelfinavir and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), respectively. The most common comorbid conditions were psychiatric disorders (depression and anxiety being the most common), hypertension, dyslipidemia, diabetes mellitus, alcohol abuse, tobacco abuse, and hepatitis (Table 2). Based on home medication lists, these conditions were being treated 33% to 50% of the time. Twenty-seven patients entered our clinic with a CD4 count <200/μL, and nine of these patients had lower CD4 counts of <50/μL. Prophylaxis for pneumocystis pneumonia and mycobacterium avium complex was continued or initiated in 70% and 56%, respectively. 1 (3%) Hypertension 8 (7%) Alcohol abuse 11 (10%) Tobacco abuse 29 (26%) Hepatitis B 4 (4%) Hepatitis C 9 (8%) DISCUSSION Disease states found in our HIV-positive Native American patients refl ect those reported in national data for Native American patients. However, there was a lower prevalence of hypertension, diabetes mellitus, and cardiac disease than would be anticipated. This could be due to the overall younger age of the study patient population. Data including all ethnicities has shown a higher frequency of the metabolic syndrome among patients between 45 and 64 than in younger populations (2). Nevertheless, due to the known increased risk in the Native American population for metabolic disease, patients should be closely monitored for this disease state and screened as appropriate. Serum glucose levels should be monitored 80 with the initiation/change of antiretroviral therapy and 70 every 6 months thereafter; 60 monitoring should be more frequent if abnormalities 50 are found (3). The NRTIs didanosine, stavudine, and 40 Male zidovudine as well as some Female protease inhibitors, particu30 larly those that are ritonavir 20 boosted, have been found to increase the risk of diabetes 10 mellitus and insulin resistance (3–5). Non-nucleoside 0 reverse transcriptase inhibiMSM Heterosexual IVDU Not Other tors (NNRTI) and integrase Documented inhibitors do not appear to Figure. Modes of transmission among 112 Native American HIV-positive patients. MSM indicates men having sex with alter insulin resistance and men; IVDU, intravenous drug use. 104 Baylor University Medical Center Proceedings Volume 27, Number 2 would be better choices in a patient with diabetes or a patient at risk for diabetes. Adult HIV guidelines list NRTIs (stavudine, zidovudine, abacavir), the NNRTI efavirenz, and all ritonavir-boosted protease inhibitors as having the risk of increasing lipid levels (3). A baseline fasting lipid profile should be drawn prior to therapy initiation, and the risk of dyslipidemia should be assessed. Lipid levels should be monitored annually, and it is not unreasonable to check a fasting lipid profile 4 to 8 weeks after starting a new regimen (3). Due to the risk of cardiovascular disease in Native Americans, it may be prudent to avoid the above regimens if possible; however, HIV should be treated despite the risk of vascular disease (5). When choosing a regimen for a Native American HIVpositive patient, it is important to assess possible adverse effects as they will affect or precipitate comorbid conditions (6). Currently, three of the four preferred regimens supported by adult HIV treatment guidelines contain a component that could precipitate diabetes mellitus, dyslipidemia, or psychiatric comorbid issues. The preferred integrase inhibitor regimen and the alternative non-efavirenz-containing NNRTI regimens appear to be favorable regimens to use in patients at risk for these conditions. The risk of precipitating a comorbid adverse event should not deter treatment of HIV. Monitoring should be done in accordance April 2014 with current guidelines to reduce and prevent medication complications. Newer therapies on the market, such as elvitegravir/ cobicistat or dolutegravir, may also have a role in these patients. Centers for Disease Control and Prevention. HIV Surveillance Report 2010. Atlanta, GA: CDC, March 2012. Available at http://www.cdc.gov/hiv/ topics/surveillance/resources/reports/. 2. Schiller JS, Lucas JW, Ward BW, Peregoy JA. Summary health statistics for U.S. adults: National Health Interview Survey, 2010. Vital Health Stat 2012;10(252):1–207. 3. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Rockville, MD: US Department of Health and Human Services. Available at http://www.aidsinfo.nih.gov/contentfiles/ lvguidelines/adultandadolescentgl.pdf. 4. Bozzette SA, Ake CF, Tam HK, Chang SW, Louis TA. Cardiovascular and cerebrovascular events in patients treated for human immunodeficiency virus infection. N Engl J Med 2003;348(8):702–710. 5. Brown TT, Cole SR, Li X, Kingsley LA, Palella FJ, Riddler SA, Visscher BR, Margolick JB, Dobs AS. Antiretroviral therapy and the prevalence and incidence of diabetes mellitus in the multicenter AIDS cohort study. Arch Intern Med 2005;165(10):1179–1184. 6. De Wit S, Sabin CA, Weber R, Worm SW, Reiss P, Cazanave C, El-Sadr W, Monforte Ad, Fontas E, Law MG, Friis-Møller N, Phillips A; Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. Incidence and risk factors for new-onset diabetes in HIV-infected patients: the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. Diabetes Care 2008;31(6):1224–1229. 1. Characteristics of Native Americans with HIV and implications for care 105