Baseline antiretroviral resistance and clinical outcomes in an urban HIV clinic
| Autor: | Ferealem Assefa, Tagbo J. Ekwonu, Olga M. Klibanov, Christian R. Dolder |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty Urban Population Pharmacist HIV Infections Drug resistance Microbial Sensitivity Tests Logistic regression Ambulatory Care Facilities Acquired immunodeficiency syndrome (AIDS) Statistical significance Internal medicine Antiretroviral Therapy Highly Active Drug Resistance Viral medicine North Carolina Prevalence Humans Retrospective Studies business.industry Public Health Environmental and Occupational Health HIV Retrospective cohort study RNA-Directed DNA Polymerase medicine.disease Clinical trial Exact test Infectious Diseases Treatment Outcome Anti-Retroviral Agents Socioeconomic Factors Mutation Regression Analysis Female business |
| Zdroj: | AIDS patient care and STDs. 27(4) |
| ISSN: | 1557-7449 |
| Popis: | Transmitted drug resistant mutations (TDRMs) of HIV in North America and Europe have been well documented over the last decade. In the United States, TDRM rates are up to 19% of HIV-infected patients who are naive to treatment, and baseline drug resistance testing is now the standard of care of HIV-infected individuals. Our urban setting clinic currently provides care to approximately 250 HIV-infected individuals. Since the clinic opened in 2008, baseline resistance testing has been performed in newly diagnosed patients, but the rates of baseline drug resistance have never been quantified. The main objective of this retrospective study was to quantify TDRM rates, 2008–2011. Due to some data suggesting that patients in urban clinic settings may not achieve the same high levels of virologic success rates as patients in large prospective HIV clinical trials, the secondary objective of our study was to evaluate virologic outcomes in treatment-naive patients after initiation of highly active antiretroviral therapy (HAART). All treatment-naive HIV-1-infected adults who had baseline genotype testing performed (2008–2011) were retrospectively evaluated. Analysis of the HIV pol and protease genes was performed by Virco Laboratory. Antiretroviral drug resistance was defined based on the International AIDS Society 2011 definition and the CDC surveillance mutation list 2009. To evaluate virologic outcomes, only patients who started HAART 2008–2010 were included, since 12-month data for the year 2011 were not available at the time of data analysis. Persistence in care was defined as availability of ‡ 12 months of follow up data. Virologic success was defined as HIV-1 RNA < 50 copies after 12 months of therapy. The primary objective, the prevalence of TDRMs between 2008 and 2011, was assessed using Pearson’s chi-square analysis and the Fisher’s exact test as appropriate. Predictors of persistence with care and the ability to achieve HIV-1 RNA < 50 copies/mL were examined using logistic regression. Age, gender, ethnicity, new HIV diagnosis, baseline CD4 count, baseline HIV-1 RNA level, type of initial of HAART therapy, and baseline pharmacist counseling were entered into the regression analysis. These predictors were chosen based on previous studies, and variables we predetermined to be of interest. Descriptive statistics were also used as appropriate. We conducted analyses using SPSS version 15.0. Tests were two-tailed with statistical significance set at a p value of less than 0.05. Wingate University’s research review board approved this study. Between 2008 and 2011, 189 treatment-naive HIV-1-infected adults had resistance testing performed. Baseline characteristics were as follows: male, 131 (69%); mean (SD) age, 36 (11); African American, 164 (87%); Hispanic, 7 (4%); Caucasian, 15 (8%); viral subtype B, 181 (96%); median baseline CD4 count (range), 299 (1-1,299); median log10 baseline HIV-1 RNA (range), 4.6 (2.6–6.9); median number of months between HIV diagnosis and resistance testing (range), 4 (0.25–240); recent HIV diagnosis (i.e., within 12 months of resistance testing), 137 (72%); baseline counseling by a clinical pharmacist, 80 (42%). Of the 189 patients, 19 (10.1%) had baseline resistance to ‡ 1 drug class. In the 137 recently diagnosed patients, baseline resistance was seen in 17 (12.4%). Baseline resistance to two drug classes was seen in only 1 patient. Year-to-year comparisons indicated a 0% TDRM rate in 2008, 12% in 2009, 8% in 2010, and 16% in 2011 (v = 3.19; p = 0.36) (Fig. 1). Among 137 recently diagnosed patients, TDRM rates were 0% in 2008, 13% in 2009, 10% in 2010, and 20% in 2011 ( p = 0.49). In the 19 cases with TDRMs, resistance to NNRTIs was seen in 13 (68%) patients (K103N, n = 10; Y181C, n = 2; V106M, n = 1), resistance to NRTIs was seen in 5 (26%) patients (M41L, n = 2; D67N, n = 1; K219Q, n = 1, M41L and L210W, n = 1), and 1 (5%) patient had dual class (NNRTI and PI) at baseline (K103N and L90M). Of the 137 patients initiated on HAART 2008–2010, 103 (75%) patients remained in care for ‡ 12 months and 81 (59%) achieved HIV-1 RNA level of < 50 copies after 12 months of therapy. The virologic success rate is 79% (81/103) in the as-treated analysis of the 103 patients who remained in care. Recent HIV diagnosis was the only factor significantly associated with persistence with care (OR 3.53; 95% CI 1.49 to 8.36; p = 0.004) and with achieving HIV-1 RNA < 50 copies/mL after 12 months of therapy (OR 3.78; 95% CI 1.68–8.53; p = 0.001) (Table 1). This study suggests that the prevalence of TDRMs in our clinic is similar to that reported in other clinical trials performed in the United States. Recent data from the CDC National HIV Surveillance System (2006–2009) showed a 14.7% |
| Databáze: | OpenAIRE |
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