Development of the HIV360 international core set of outcome measures for adults living with HIV: A consensus process.

OBJECTIVES: HIV outcomes centre primarily around clinical markers with limited focus on patient-reported outcomes. With a global trend towards capturing the outcomes that matter most to patients, there is agreement that standardizing the definition of value in HIV care is key to their incorporation. This study aims to address the lack of routine, standardized data in HIV care. METHODS: An international working group (WG) of 37 experts and patients, and a steering group (SG) of 18 experts were convened from 14 countries. The project team (PT) identified outcomes by conducting a literature review, screening 1979 articles and reviewing the full texts of 547 of these articles. Semi-structured interviews and advisory groups were performed with the WG, SG and people living with HIV to add to the list of potentially relevant outcomes. The WG voted via a modified Delphi process - informed by six Zoom calls - to establish a core set of outcomes for use in clinical practice. RESULTS: From 156 identified outcomes, consensus was reached to include three patient-reported outcomes, four clinician-reported measures and one administratively reported outcome; standardized measures were included. The WG also reached agreement to measure 22 risk-adjustment variables. This outcome set can be applied to any person living with HIV aged > 18 years. CONCLUSIONS: Adoption of the HIV360 outcome set will enable healthcare providers to record, compare and integrate standardized metrics across treatment sites to drive quality improvement in HIV care.

Medical personnel knowledge and stigmatic attitude toward HIV patients in a high-income country.

Negative attitudes of health care workers (HCW) toward people living with HIV (PLWH) impact patients' care, quality-of-life, therapy adherence, and retention in care. Few publications address stigma and discrimination among HCWs in high income countries. This study aims to provide a better understanding of HCW knowledge and attitudes toward caring for PLWH, how this relates to discriminatory tendencies and professional contacts, and proposes effective strategies to reduce negative attitudes and stigmas among health care providers in a tertiary hospital in Israel. Of 321 health care personnel who responded to an electronic questionnaire, HCWs had a good level of general knowledge regarding HIV. A lack of knowledge was noted regarding antiretroviral therapy influences, HIV transmission from mother to child, and HIV risks and transmission. Cultural diversity was also noted. This study supports the need to implement a training program for HCWs on HIV-related stigma-reduction.

Quantitative ultrasonometry: An alternative and easy method to evaluate bone quality in people living with human immunodeficiency virus.

BACKGROUND: HIV infection and antiretroviral therapy (ART) are associated with bone mineral loss. DXA is the gold standard method to evaluate the status of bone mineral density (BMD). However, it is not always readily available. An easy method is needed to evaluate bone quality in those infected with HIV. OBJECTIVE: To evaluate portable quantitative ultrasonometry (QUS) as an alternative technique to provide information about bone density, bone strength, and the bone turnover markers in HIV-infected people. METHODS: A total of 69 men took part (34 HIV-infected men were matched with 35 non-HIV-infected men) in the study. Bone mineral status was assessed by the Achilles quantitative ultrasonometer at the calcaneal heel. The HIV status was recorded for all HIV-infected patients. Calcium-regulating hormones and bone turnover markers were assessed in all participants. RESULTS: The mean age was 47.8±7.8 years and 49.1±6.00 years for the HIV-infected and non-infected population, respectively. The bone quality expressed as Stiffness index (SI) was reduced in HIV-infected patients. Bone turnover markers were higher in the HIV-infected patients, P1NP (ng/mL) was 48.0±14.3 vs 41.1±15.2 (P=0.057), and the (CTx)) (ng/mL) was 0.41±0.18 vs 0.29±0.11 (P=0.002). CONCLUSIONS: QUS is easy to use. Hence, QUS could be used as alternative method for screening of HIV patients for altered bone status.

[Outcome of treatment with peg-interferon and ribavirin in HIV-HCV co-infected patients: "real life" single center experience].

BACKGROUND AND AIM: Recently, with the emergence of highly effective antiretroviral treatment (ART), chronic liver disease has become the leading cause of morbidity and mortality in co-infected HIV-HCV (Human immunodeficiency virus-Hepatitis C virus) patients. The overall SVR rate in this population remains unsatisfactory. The aim of this study was to evaluate the response to therapy in HIV-HCV co-infected patients in a single center. PATIENTS AND METHODS: Consecutive HIV-HCV co-infected patients were evaluated in the liver clinic between 2003 -2010. Liver needle biopsy was conducted in 100% of the patients. The patients were treated by a multidisciplinary team consisting of immunologists, hepatologists, social workers and nurses and a close follow-up was conducted. The 48 weeks duration of peg-interferon and ribavirin combination was used for all genotypes according to recent guidelines. Weight-adjusted ribavirin doses were applied. Treatment was initiated after stabilization of HIV parameters and successful weaning from drug and alcohol addiction. RESULTS: A total of 86 out of 143 HIV- HCV co-infected patients, were evaluated; 39 completed treatment. Of those 31 (77%) achieved SVR. Out of 22 genotype 1 patients, 18 (82%) achieved SVR. Six patients had spontaneous viral clearance and 8 are still receiving treatment. In 17 non-one genotype patients, the SVR rate was 76.4% (13 of 17 patients); 6 patients were defined as relapsers and non-responders. Overall adherence to the treatment was high. CONCLUSION: Measures, such as the use of a multidisciplinary approach, high adherence of physicians to the guidelines, weight-based ribavirin dose, and selecting patients who are ready to start therapy, can significantly improve the SVR rate in this difficult-to-treat patient population.

Absence of APOL1 risk variants protects against HIV-associated nephropathy in the Ethiopian population.

BACKGROUND: Susceptibility to end-stage kidney disease (ESKD) among HIV-infected Americans of African ancestral heritage has been attributed to APOL1 genetic variation. We determined the frequency of the APOL1 G1 and G2 risk variants together with the prevalence of HIV-associated nephropathy (HIVAN) among individuals of Ethiopian ancestry to determine whether the kidney disease genetic risk is PanAfrican or restricted to West Africa, and can explain the previously reported low risk of HIVAN among Ethiopians. METHODS: We studied a cohort of 338 HIV-infected individuals of Ethiopian ancestry treated in one Israeli and one Ethiopian center. We sought clinical evidence for HIVAN (serum creatinine >1.4 mg/dl or proteinuria >30 mg/dl in a spot urine sample). Genetic analyses included the genotyping of the APOL1 G1 and G2 variants, and a panel of 33 genomic ancestry-informative markers. Statistical analysis compared clinical and genetic indices for HIV-infected individuals of Ethiopian ancestry and overall Ethiopians to those reported for HIV-infected African-Americans, overall African-Americans, West Africans and non-Africans. FINDINGS: Three (0.8%) of 338 HIV-infected patients of Ethiopian ancestry showed clinical criteria compatible with renal impairment. Two of these 3 patients also have severe poorly controlled diabetes mellitus. The third nondiabetic patient underwent renal biopsy which ruled out HIVAN. This absence of clinically apparent HIVAN was significantly different from that reported for African-Americans. The APOL1 G1 and G2 risk variants were found, respectively, in 0 and 2 (heterozygote state) of the 338 HIV-infected individuals. Global ancestry and the frequencies of the APOL1 G1 and G2 variants are not statistically different from their frequencies in the general Ethiopian population, but are significantly and dramatically lower than those observed among HIV-infected African-Americans, African-Americans and West Africans. INTERPRETATION: The coinciding absence of HIVAN and the APOL1 risk variants among HIV-infected individuals of Ethiopian ancestry support a Western rather than Pan-African ancestry risk for ESKD, and can readily explain the lack of HIVAN among individuals of Ethiopian ancestry.

The autologous serum skin test in a cohort of chronic idiopathic urticaria patients compared to respiratory allergy patients and healthy individuals.

BACKGROUND: A positive autologous serum skin test (ASST) is considered to reflect the presence of anti-FceRI and/or anti-IgE autoantibodies that are capable of activating mast and basophil cell degranulation. The ASST is regarded as a reliable in vivo test in chronic idiopathic urticaria (CIU) patients, with diagnostic, therapeutic and prognostic implications. However, positive ASST results have also occasionally been demonstrated in patients with other diseases and in healthy subjects. OBJECTIVE: To evaluate the specificity and sensitivity of the ASST in a cohort of CIU patients compared to a cohort of respiratory-allergic patients and a group of normal individuals. METHODS: ASST was performed in a cohort of 116 subjects, 47 subjects with seasonal allergic rhinitis, 32 respiratory-symptom-free CIU patients, and 37 healthy individuals. RESULTS: The results were compared statistically to those of the CIU patients. The intradermal injection of autologous serum induced a weal and flare reaction in 17/32 (53.1%) CIU patients; 14/47 (29.8%) patients with seasonal allergic rhinitis (P=0.06) and in 15/37 (40.5%) of the healthy controls (P=0.34). The sensitivity and specificity of the ASST in the CIU patients and the seasonal allergic rhinitis patients was 53 and 28%, respectively. When comparing the CIU patients with the healthy controls the sensitivity and specificity was 55 and 31%, respectively. The positive and negative predictive values of the ASST when comparing CIU patients with healthy controls were 53 and 59.5%, respectively. The positive and negative predictive values of the ASST in the CIU patients compared to seasonal allergic rhinitis patients were 53 and 70%, respectively. CONCLUSION: The relatively low sensitivity and specificity of the ASST in the CIU patients compared to the seasonal allergic rhinitis patients and healthy controls warrants a more critical interpretation of the ASST in chronic idiopathic urticaria.

Absence of HIV-associated nephropathy in Ethiopians.

BACKGROUND: Population-based epidemiological surveys in several countries have shown approximately 10- to 15-fold increased susceptibility to human immunodeficiency virus (HIV)-associated nephropathy (HIVAN) for populations of recent African ancestry. Accordingly, we sought to determine whether a similar or different pattern of susceptibility was evident among Ethiopians followed up in an HIV clinic in Israel. METHODS: One hundred seventy-six consecutive patients (126 Ethiopians, 50 non-Ethiopian Israelis) followed up at the HIV clinic of Rambam Medical Center in northern Israel were examined for the presence of proteinuria and/or decreased glomerular filtration rate. HIV viral load, CD4 count, and treatment modality also were determined. RESULTS: Overall, 73% of patients were treated with highly active antiretroviral therapy, and there was no difference between Ethiopians and non-Ethiopian Israelis in this regard. Mean CD4 count in Ethiopians was 288 +/- 140/microL, significantly less than the corresponding CD4 count of 398 +/- 190/microL for non-Ethiopian Israelis. Mean viral loads were greater in Ethiopians compared with non-Ethiopian Israelis. None of 176 HIV-infected patients fulfilled clinical criteria for HIVAN as delineated in this study. CONCLUSION: HIV-infected individuals of Ethiopian descent have a level of susceptibility to HIVAN similar to that of non-Ethiopian Israelis, which is strikingly less than that reported for other populations for recent African ancestry. This does not appear to be attributable to differences in HIV infection control or viral subtype and most likely represents population-based differences in host genetic factors. This finding emphasizes the importance of avoiding generalizations with respect to phylogeographic ancestry in disease-susceptibility studies.