Publications

BACKGROUND & AIMS

We conducted a phase 4, open-label study with limited exclusion criteria to evaluate the safety and efficacy of sofosbuvir and ribavirin in veterans with hepatitis C virus genotype 2 infection, and compensated cirrhosis. This population is often excluded from clinical studies.

METHODS

We performed a prospective study of treatment-naive (n = 47) and treatment-experienced (n = 19) patients with chronic hepatitis C virus genotype 2 infection and compensated cirrhosis at 15 Department of Veterans Affairs sites. All subjects were given sofosbuvir (400 mg, once daily) plus ribavirin (1000-1200 mg/day) in divided doses for 12 weeks. Patients with major psychiatric diseases or alcohol or substance use disorders were not excluded. The primary endpoint was sustained virologic response 12 weeks after therapy.

RESULTS

Fifty-two patients achieved a sustained virologic response 12 weeks after therapy (79%; 95% confidence interval, 67%-88%); 16 of these patients were treatment experienced (84%; 95% confidence interval, 60%-97%) and 36 were treatment naive (77%; 95% confidence interval, 62%-88%). All patients had at least 1 comorbidity. Thirty-five percent had depression, 24% had posttraumatic stress disorder, and 30% had anxiety disorder. In addition, 29% had current substance use. Of the 7 patients (11%) who discontinued the study treatment prematurely, 3 did so because of adverse events. The most common adverse events were fatigue, anemia, nausea, and headache. Serious adverse events occurred in 8 patients. Only 2 of the serious adverse events (anemia and nausea) were considered to be related to study treatment.

CONCLUSIONS

In a phase 4 study, 12 weeks treatment with sofosbuvir and ribavirin led to a sustained virologic response 12 weeks after therapy in almost 80% of veterans with hepatitis C virus genotype 2 infection, compensated cirrhosis, and multiple comorbidities, regardless of their treatment history. ClinicalTrials.gov, Number: NCT02128542.

BACKGROUND

Antiretroviral therapy scale-up in Sub-Saharan Africa has created a growing, aging HIV-positive population at risk for non-communicable diseases such as hypertension. However, the prevalence and risk factors for hypertension in this population remain incompletely understood.

METHODS

We measured blood pressure and collected demographic data on over 65,000 adults attending multi-disease community health campaigns in 20 rural Ugandan communities (SEARCH Study: NCT01864603). Our objectives were to determine (i) whether HIV is an independent risk factor for hypertension, and (ii) awareness and control of hypertension in HIV-positive adults and the overall population.

RESULTS

Hypertension prevalence was 14% overall, and 11% among HIV-positive individuals. 79% of patients were previously undiagnosed, 85% were not taking medication, and 50% of patients on medication had uncontrolled blood pressure. Multivariate predictors of hypertension included older age, male gender, higher BMI, lack of education, alcohol use, and residence in Eastern Uganda. HIV-negative status was independently associated with higher odds of hypertension (OR 1.2, 95% CI: 1.1-1.4). Viral suppression of HIV did not significantly predict hypertension among HIV-positives.

SIGNIFICANCE

The burden of hypertension is substantial and inadequately controlled, both in HIV-positive persons and overall. Universal HIV screening programs could provide counseling, testing, and treatment for hypertension in Sub-Saharan Africa.

BACKGROUND

Pest allergen sensitization is associated with asthma morbidity in urban youth but minimally explored in Latino populations. Specifically, the effect of mouse sensitization on the risk of asthma exacerbation has been unexplored in Latino subgroups.

OBJECTIVE

To evaluate whether pest allergen sensitization is a predictor of asthma exacerbations and poor asthma control in urban minority children with asthma.

METHODS

Latino and African American children (8-21 years old) with asthma were recruited from 4 sites across the United States. Logistic regression models evaluated the association of mouse or cockroach sensitization with asthma-related acute care visits or hospitalizations.

RESULTS

A total of 1,992 children with asthma in the Genes-environments and Admixture in Latino American (GALA-II) and Study of African-Americans, Asthma, Genes, and Environments (SAGE-II) cohorts were studied. Asthmatic children from New York had the highest rate of pest allergen sensitization (42% mouse, 56% cockroach), with the lowest rate in San Francisco (4% mouse, 8% cockroach). Mouse sensitization, more than cockroach, was associated with increased odds of acute care visits (adjusted odds ratio [aOR], 1.47; 95% CI, 1.07-2.03) or hospitalizations (aOR, 3.07; 95% CI, 1.81-5.18), even after controlling for self-reported race and site of recruitment. In stratified analyses, Mexican youth sensitized to mouse allergen did not have higher odds of asthma exacerbation. Other Latino and Puerto Rican youth sensitized to mouse had higher odds of hospitalization for asthma (aORs, 4.57 [95% CI, 1.86-11.22] and 10.01 [95% CI, 1.77-56.6], respectively) but not emergency department visits.

CONCLUSION

Pest allergen sensitization is associated with a higher odds of asthma exacerbations in urban minority youth. Puerto Rican and Other Latino youth sensitized to mouse were more likely to have asthma-related hospitalizations than Mexican youth.

BACKGROUND

Alcohol and illicit drug use is more prevalent among men who have sex with men (MSM) compared to the general population and has been linked to HIV transmission in this population. Research assessing individual patterns of substance use often utilizes questionnaires or interviews that rely on retrospective self-reported information, which can be subject to recall bias. Ecological momentary assessment (EMA) is a set of methods developed to mitigate recall bias by collecting data about subjects' mental states and behaviors on a near real-time basis. EMA remains underutilized in substance use and HIV research.

OBJECTIVE

To assess the concordance between daily reports of substance use collected by EMA text messages (short message service, SMS) and retrospective questionnaires and identify predictors of daily concordance in a sample of MSM.

METHODS

We conducted a secondary analysis of EMA text responses (regarding behavior on the previous day) and audio computer-assisted self-interview (ACASI) survey data (14-day recall) from June 2013 to September 2014 as part of a randomized controlled trial assessing a pharmacologic intervention to reduce methamphetamine and alcohol use among nondependent MSM in San Francisco, California. Reports of daily methamphetamine use, alcohol use, and binge alcohol use (5 or more drinks on one occasion) were collected via EMA and ACASI and compared using McNemar's tests. Demographic and behavioral correlates of daily concordance between EMA and ACASI were assessed for each substance, using separate multivariable logistic regression models, fit with generalized estimating equations.

RESULTS

Among 30 MSM, a total of 994 days were included in the analysis for methamphetamine use, 987 for alcohol use, and 981 for binge alcohol use. Methamphetamine (EMA 20%, ACASI 11%, P<.001) and alcohol use (EMA 40%, ACASI 35%, P=.001) were reported significantly more frequently via EMA versus ACASI. In multivariable analysis, text reporting of methamphetamine (adjusted odds ratio 0.06, 95% CI 0.04-0.10), alcohol (0.48, 0.33-0.69), and binge alcohol use (0.27, 0.17-0.42) was negatively associated with daily concordance in the reporting of each respective substance. Compared to white participants, African American participants were less likely to have daily concordance in methamphetamine (0.15, 0.05-0.43) and alcohol (0.2, 0.05-0.54) reporting, and other participants of color (ie, Asian, Hispanic, multi-racial) were less likely to have daily concordance in methamphetamine reporting (0.34, 0.12-1.00). College graduates were more likely to have daily concordance in methamphetamine reporting (6.79, 1.84-25.04) compared to those with no college experience.

CONCLUSIONS

We found that methamphetamine and alcohol use were reported more frequently with daily EMA texts compared to retrospective ACASI, concordance varied among different racial/ethnic subgroups and education levels, and reported substance use by EMA text was associated with lower daily concordance with retrospective ACASI. These findings suggest that EMA methods may provide more complete reporting of frequent, discrete behaviors such as substance use.