Publications

BACKGROUND

Hepatitis C virus (HCV) RNA monitoring during antiviral therapy is essential for early prediction of treatment success and failure to peginterferon alfa/ribavirin (PEG-IFN/RBV) therapy.

OBJECTIVES

In this multi-center study we assessed the clinical utility of the Abbott RealTime HCV assay for monitoring patients undergoing antiviral therapy for chronic infection with HCV genotypes (GT) 1-3.

STUDY DESIGN

We analyzed serum from 361 patients with chronic hepatitis C who had been treated with PEG-IFN/RBV. The predictive value of rapid virologic response (RVR), partial (≥2log(10) decline) and complete (HCV-RNA undetectable) early virologic response (pEVR/cEVR) based on RealTime HCV for achieving sustained virologic response was evaluated. In addition, the utility of RealTime HCV to tailor treatment duration according to individual virologic responses was studied in a subset of 136 GT 1 patients and compared to the reference tests, Versant HCV Quantitative 3.0 (bDNA) and Qualitative (TMA) assay.

RESULTS

At week 4 of therapy, patients with RVR had a 100% and 93.5% probability to achieve an SVR in GT 1 and GT 2/3 patients, respectively. At week 12, patients who did not achieve a pEVR had a 97.2% and 100% probability of not achieving an SVR. In addition, assignment of GT 1 patients to abbreviated or extended treatment durations based on low baseline HCV-RNA (<800,000IU/mL) and RVR or pEVR was highly concordant between RealTime HCV and bDNA/TMA assays (97.8% and 91.9%, respectively).

CONCLUSIONS

The RealTime HCV assay is suitable for monitoring virologic response to PEG-INF/RBV therapy and tailoring treatment duration accordingly.

CONTEXT

The treatment of pain in patients with substance use disorders creates tensions for clinicians between undertreating pain and enabling opioid analgesic misuse.

OBJECTIVES

To characterize prevalence and factors associated with aberrant opioid analgesic behaviors in a cohort of HIV-infected individuals who are at high risk for opioid analgesic misuse.

METHODS

We assessed pain and substance use disorders in a cross-sectional study that enrolled 296 participants from the Research on Access to Care in the Homeless cohort, a community-based sample of indigent HIV-infected adults. We measured aberrant opioid behaviors, defined as major or minor depending on level of risk of harm to patients, using Audio Computer-Assisted Self-Interview technology.

RESULTS

Most participants (91.2%) reported pain in the week before interview, with the majority of these experiencing severe pain (53.7%). More than two-thirds (69.2%) of the participants met criteria for a lifetime history of cocaine, amphetamine, or heroin/opioid use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition). More than one-third of the sample (37.4%) had a history of aberrant opioid behavior within 90 days of interview. One-fifth (18.5%) had a history of "major" aberrant behaviors.

CONCLUSION

In this high-risk population, severe pain is common and aberrant opioid behaviors are prevalent but not universal. As recommended by American Pain Society and American Academy of Pain Medicine guidelines, when prescribing opioid analgesics, clinicians must consider variation in the severity of aberrant behaviors, particularly aberrant behaviors that may represent undertreatment of pain.

OBJECTIVE

To identify demographic and clinical risk factors associated with mortality after initiation of antiretroviral therapy (ART) in a cohort of human immunodeficiency (HIV) infected children in KwaZulu-Natal, South Africa.

METHODS

We performed a retrospective cohort study of 537 children initiating antiretroviral therapy at McCord Hospital in KwaZulu-Natal, South Africa. Data were extracted from electronic medical records and risk factors associated with mortality were assessed using Cox regression analysis.

RESULTS

Overall there were 47 deaths from the cohort of 537 children initiating ART with over 991 child-years of follow-up (median 22 months on ART), yielding a mortality rate of 4.7 deaths per 100 child years on ART. Univariate analysis indicated that mortality was significantly associated with lower weight-for-age Z-score (p<0.0001), chronic diarrhea (p = 0.0002), lower hemoglobin (p = 0.002), age <3 years (p = 0.003), and CD4% <10% (p = 0.005). The final multivariable Cox proportional hazards mortality model found age less than 3 years (p = 0.004), CD4 <10% (p = 0.01), chronic diarrhea (p = 0.03), weight-for-age Z-score (<0.0001) and female gender as a covariate varying with time (p = 0.03) all significantly associated with mortality.

CONCLUSION

In addition to recognized risk factors such as young age and advanced immunosuppression, we found female gender to be significantly associated with mortality in this pediatric ART cohort. Future studies are needed to determine whether intrinsic biologic differences or socio-cultural factors place female children with HIV at increased risk of death following initiation of ART.