Measuring stigma associated with tuberculosis and HIV/AIDS in southern Thailand: exploratory and confirmatory factor analyses of two new scales

Objective  To develop scales to measure tuberculosis and HIV/AIDS stigma in a developing world context.
Methods  Cross-sectional study of tuberculosis patients in southern Thailand, who were asked to rate their agreement with items measuring TB and HIV/AIDS stigma. Developing the scales involved exploratory and confirmatory factor analyses, internal consistency, construct validity, test–retest reliability and standardized summary scores.
Results  Factor analyses identified two sub-scales associated with both tuberculosis and HIV/AIDS stigma: community and patient perspectives. Goodness-of-fit was good (TLI = 94, LFI = 0.88 and RMSEA = 0.11), internal consistency was excellent (Cronbach's alphas 0.82–0.91), test–retest reliability was moderate, and construct validity showed an inverse correlation with social support.
Conclusion  Our scales have good psychometric properties that measure stigma associated with tuberculosis and HIV/AIDS and allow assessment of stigma from community and patient perspectives. Their use will help document the burden of stigma, guide the development of interventions and evaluate stigma reduction programmes in areas with a high HIV/AIDS and tuberculosis burden.     

云南省HIV／AIDS病人早期抗病毒治疗的有效性和安全性分析

目的评价云南省艾滋病病毒（HIV）感染者／艾滋病（AIDS）病人（HIV／AIDs病人）早期抗反转录病毒治疗（ART）的有效性和安全性。方法对云南省2011年8月至2012年8月期间开始ART的病人,按照基线CD4淋巴细胞（CD4细胞）计数水平分A、B两组,A组为基线CD4细胞计数〉350／±的病人（早期治疗组）,B组为基线CD4细胞计数≤350／μL．的病人（延迟治疗组）。比较两组病人治疗满1年后的队列保持情况、治疗效果、治疗期间病人的不良反应和机会性感染发生等情况。结果两组9810例病人治疗满1年后,在队列保持方面,A组病人坚持治疗的比例（在治率）为88．0％（1712／1946）,高于B组的84．9％（6674／7864）;死亡率A组（1．2％）低于B组（5．7％）;在治疗效果方面,两组的HIV病毒载量抑制比例差异无统计学意义（P〉0．05）,两组病人中．HIV病毒载量〈C400拷贝／mL病人所占比例,分别为90．4％和91．2％;治疗6个月和12个月时,与基线CD4细胞计数相比,A组的增幅（4．32％）（治疗前后CD4细胞差值的比较）低于B组（10．27％）,P〈0．01,但A组病人仍然获得比B组较高的CD4细胞平均值;在机会性感染和不良反应方面,A组的发生比例（4．3％和20．9％）均低于B组（10．3％和24．3％）,P〈0．01。结论云南省HIV／AIDS病人早期治疗12个月能够获得良好的有效性和安全性,初步实现了减少HIV相关的发病率和死亡率、非艾滋病相关疾病的发病率和死亡率和改善生活质量的抗病毒治疗总体目标。     

Effects of HIV infection on age and cause of death for persons with hemophilia A in the United States

Because of changes in factor replacement therapy and in treatment of human immunodeficiency virus (HIV) infection, we examined death record data for persons with hemophilia A in the United States to evaluate effects of HIV infection on age and causes of death. Multiple cause-of-death data from 1968 through 1998 were examined to assess death rates for persons with hemophilia A. ICD-9 coded causes of death from 1979 through 1998 were examined to assess long-term trends. From 1979 through 1998, 4,781 deaths among persons with hemophilia A were reported, of which 2,254 (47%) had HIV-related disease listed as a cause of death. In the late 1980s, mortality among persons with hemophilia A increased markedly, and the age-adjusted death rate peaked at 1.5 per 1,000,000 population in 1992. Median age at death decreased from 55 years in 1979-1982 to 40.5 years in 1987-1990, and increased to 46 years in 1995-1998. In the period 1995-1998, the median age of hemophilia A decedents with HIV-related disease was 33 years, compared to 72 years for those without HIV-related disease; the most frequently listed causes of death for those without HIV-related disease were hemorrhagic and circulatory phenomena; the most frequently listed for those with HIV-related disease were diseases of liver and the respiratory system. From 1995 to 1998, hemophilia A-associated deaths decreased by 41%, with a 78% decrease among those who had HIV-related disease. Although HIV infection has adversely effected mortality for persons with hemophilia A, the marked recent decrease in the death rate among persons with hemophilia A appears to reflect advances in care for those with HIV-related disease and is consistent with a decline in HIV mortality observed in the general population.     

Long-Term Quality-of-Life Outcomes Among Adults Living with HIV in the HAART Era: The Interplay of Changes in Clinical Factors and Symptom Profile

Changes in quality-of-life perceptions and their relations to clinical status for 41 adult outpatients living with HIV/AIDS were assessed over a 4-year period. Clinical variables and quality-of-life (Medical Outcomes Study Short-Form-36) ratings were measured in three waves (T1, 1997; T2, 1999; T3, 2001). Mean T1-T3 CD4 increase was 196 cells/microL (p < .0001), corresponding to a mean viral load reduction of 1.4 log10 copies/mL (p < .0001) and an increase in proportions with "undetectable" viral load status from 32% to 61% (p < .01). The T1-T2 increase in overall mean number of symptoms (including both disease-related symptom complex and treatment side effects) was mitigated by T2-T3 symptom reduction. Quality-of-life dimensions were generally stable or slightly improved over time for the overall sample, a finding that contrasts with pre-highly active antiretroviral therapy longitudinal research. Mental aspects of quality of life remained consistently lower than reference norms. Results of multiple regression suggested that quality of life was less sensitive to immunologic/virologic changes compared to responsiveness to symptom changes, consistent with cross-sectional inverse relations between symptom burden and quality of life. CD4 repletion offset negative effects of symptoms for some aspects of quality of life. The long-term course of quality of life was somewhat predicted by viral load suppression due to the conjoint influence of symptoms and CD4 count.     

静脉药瘾并HIV感染者感染性心内膜炎13例临床分析

目的 总结静脉药瘾并HIV感染者感染性心内膜炎(infective endoearditis,IE)的资料,提高对这种特殊类型IE的认识。方法 回顾性分析13例静脉药瘾并HIV感染者IE的临床资料。结果 男女比例为12:1,年龄27～39岁,无基础心脏疾病。主要临床表现为发热(100％,13/13)、心脏杂音(84.6％,11/13)、咳嗽、咳痰、气促(76.90A,10/13)。84.6％(11/13)的患者血象升高,61.5％(8/13)血培养阳性,以金黄色葡萄球菌最多见(5/8)。死亡病例的CD4 细胞计数明显降低。所有病例均合并肺部感染,痰培养以真菌最多见(7/12)。心电图表现以窦速合并ST-T改变多见。超声心动图显示三尖瓣受累最常见(92.3％,12/13),其次为二尖瓣(3/13),10例赘生物全部位于三尖瓣。结论 静脉药瘾并HIV感染者的IE以右心感染多见,发热、心脏杂音和血培养是诊断的重要依据,常合并肺部感染,超声心动图检查和T淋巴细胞分类对于判断预后有一定价值。     

Recombinant human erythropoietin in the treatment of anemia associated with human immunodeficiency virus (HIV) infection and zidovudine therapy. Overview of four clinical trials.

OBJECTIVE: To assess the effect of recombinant human erythropoietin (r-HuEPO) on anemia in patients with the acquired immunodeficiency syndrome (AIDS) who are receiving zidovudine therapy. DESIGN: Combined analysis of four 12-week, randomized, double-blind, controlled clinical trials. SETTING: Multiple centers in the United States. PATIENTS: Two hundred and ninety-seven anemic (hematocrit < 30%) patients with AIDS who were receiving zidovudine therapy. Of the 297 patients, 255 were evaluable for efficacy, but all patients were included in analysis of safety. INTERVENTION: Patients were randomly assigned to receive either r-HuEPO (100 to 200 U/kg body weight) or placebo, intravenously or subcutaneously, three times per week for up to 12 weeks. MEASUREMENTS: Changes in mean hematocrit, transfusion requirement, and quality of life. RESULTS: Sixty-nine percent of patients had endogenous serum erythropoietin levels less than or equal to 500 IU/L, and 31% had erythropoietin levels greater than 500 IU/L. In patients with low erythropoietin levels (< or equal to 500 IU/l), r-HuEPO therapy decreased the mean number of units of blood transfused per patient when compared with placebo (3.2 units and 5.3 units, respectively; P = 0.003) and increased the mean hematocrit from the baseline level (4.6 percentage points and 0.5 percentage points, respectively; P <0.001). Overall quality of life improved in patients on r-HuEPO therapy (P = 0.13). Patients with erythropoietin levels greater than 500 IU/L showed no benefit from r-HuEPO in any outcome variable. Placebo and r-HuEPO recipients did not differ in the incidence of adverse effects or opportunistic infections. CONCLUSION: Therapy with r-HuEPO can increase the mean hematocrit and decrease the mean transfusion requirement in anemic patients with AIDS who are receiving zidovudine and have endogenous low erythropoietin levels (< or equal to 500 IU/L). Such therapy is of no apparent benefit in patients whose endogenous erythropoietin levels are higher than 500 IU/L.     

Management and treatment of hepatitis B virus in patients with HIV infection: A practical guide for health care professionals

The management and treatment of HIV and hepatitis B virus (HBV)-coinfected patients present specific challenges for clinicians. The morbidity and mortality related to these concomitant infections are growing concerns, while the use of antiviral drugs effective against both viruses complicates therapeutic decision making. The present document provides guidelines for physicians regarding care and treatment of patients coinfected with HIV and HBV. Primary prevention of HBV in HIV-positive patients is achieved through appropriate vaccination schedules. Follow-up before treatment of HBV may include liver biopsy, screening for hepatocellular carcinoma and testing for esophageal varicies in cases of cirrhosis. In HBV-infected patients requiring treatment, recommendations regarding initiation, duration and choice of first-line drugs are made. Finally, in the case of resistance, appropriate alternative therapies are necessary.     

Recruitment of HIV/AIDS treatment‐naïve patients to clinical trials in the highly active antiretroviral therapy era: influence of gender,sexual orientation and race

Background

In the USA, women, racial/ethnic minorities and persons who acquire HIV infection through heterosexual intercourse represent an increasing proportion of HIV‐infected persons, and yet are frequently underrepresented in clinical trials. We assessed the demographic predictors of trial participation in antiretroviral‐naïve patients.

Methods

Patients were characterized as trial participants if highly active antiretroviral therapy (HAART) was initiated within a clinical trial. Prevalence ratios (PRs) were obtained using binomial regression.

Results

Between 1996 and 2006, 30% of 738 treatment‐naïve patients initiated HAART in a clinical trial. Trial participation rates for men who have sex with men (MSM), heterosexual men, and women were respectively 36.5, 29.6 and 24.3%. After adjustment for other factors, heterosexual men appeared less likely to participate in trials compared with MSM [PR 0.79, 95% confidence interval (CI) 0.57, 1.11], while women were as likely to participate as MSM (PR 0.97, 95% CI 0.68, 1.39). The participation rate in Black patients (25.9%) was lower compared with non‐Black patients (37.5%) (adjusted PR 0.80, 95% CI 0.60, 1.06).

Conclusions

In our clinical setting, gender did not appear to impact participation in HIV treatment trials, but Black patients were slightly less likely to participate in these trials. Considering the substantial proportion of HIV‐infected patients who are Black, future trials need to consider strategies to incorporate such underrepresented populations.     

Comparison of satisfaction with care between two different models of HIV care delivery in St. Petersburg,Russia

Prior to 2010, medical care for people living with HIV/AIDS was provided at an outpatient facility near the center of St. Petersburg. Since then, HIV specialty clinics have been established in more outlying regions of the city. The study examined the effect of this decentralization of HIV care on patients’ satisfaction with care in clinics of St. Petersburg, Russia. We conducted a cross-sectional study with 418 HIV-positive patients receiving care at the St. Petersburg AIDS Center or at District Infectious Disease Departments (centralized and decentralized models, respectively). Face-to-face interviews included questions about psychosocial characteristics, patient's satisfaction with care, and clinic-related patient experience. Abstraction of medical records provided information on patients’ viral load. To compare centralized and decentralized models of care delivery, we performed bivariate and multivariate analysis. Clients of District Infectious Disease Departments spent less time in lines and traveling to reach the clinic, and they had stronger relationships with their doctor. The overall satisfaction with care was high, with 86% of the sample reporting high level of satisfaction. Nevertheless, satisfaction with care was strongly and positively associated with the decentralized model of care and Patient–Doctor Relationship Score. Patient experience elements such as waiting time, travel time, and number of services used were not significant factors related to satisfaction. Given the positive association of satisfaction with decentralized service delivery, it is worth exploring decentralization as one way of improving healthcare services for people living with HIV/AIDS.     

Efficacy and safety of sacubitril-valsartan in patients with heart failure: a systematic review and meta-analysis of randomized clinical trials: A PRISMA-compliant article

Background:To investigate the efficacy and safety of sacubitril-valsartan in patients with heart failure, relevant randomized clinical trials (RCTs) were analyzed.Methods:We used Cochrane Library, PubMed web of science, CNKI, VIP, Medline, ISI Web of Science, CBMdisc, and Wanfang database to conduct a systematic literature research. A fixed-effects model was used to evaluate the standardized mean differences (SMDs) with 95% confidence intervals. We conducted sensitivity analysis and analyzed publication bias to comprehensively estimate the efficacy and safety of sacubitril-valsartan in patients with heart failure.Results:Among 132 retrieved studies, 5 relevant RCTs were included in the meta-analysis. The result showed that left ventricular ejection fraction (LVEF) was improved after sacubitril-valsartan in patients with heart failure, with an SMD (95% CI of 1.1 [1.01, 1.19] and P < .00001 fixed-effects model). Combined outcome indicators showed that, combined outcome indicators showed that, compared with control group, the left ventricular volume index (LAVI) (WMD = −2.18, 95% CI [−3.63, −0.74], P = .003), the E/e’ (WMD = −1.01, 95% CI [−1.89, −0.12], P = .03), the cardiovascular death (RR = 0.89, 95% CI [0.83, 0.96], P = .003], and the rehospitalization rate of heart failure (RR = 0.83, 95% CI [0.78, 0.88], P < .01) decreased more significantly, but it had no effect on renal function (WMD = 0.74, 95% CI [0.54, 1.01], P = .06).Conclusions:The present meta-analysis suggested that sacubitril-valsartan may improve the cardiac function of heart failure. Given the limited number of included studies, additional large sample-size RCTs are required to determine the long-term effect of cardiac function of sacubitril-valsartan in patients with heart failure.     

Health utility measurement for people living with HIV/AIDS under combined antiretroviral therapy: A comparison of EQ-5D-5L and SF-6D

We compared the discriminative validity, agreement and sensitivity of EQ-5D-5L and SF-6D utility scores in people living with HIV/AIDS (PLWHIV). We conducted a cross-sectional survey among PLWHIV aged more than 18 years old in 9 municipalities in Yunnan Province, China. A convenience sample was enrolled. We administered the SF-12 and EQ-5D-5L to measure health-related quality of life. The utility index of the SF-6D was derived from the SF-12. We calculate correlation coefficients to evaluate the relationship and agreement of 2 instruments. To evaluate the homogeneity of the EQ-5D-5L and SF-6D, intraclass correlation coefficients, scatter plots, and Bland–Altman plots were computed and drawn. We also used receiver operating characteristic curves to compare the discriminative properties and sensitivity of the econometric index. A total of 1797 respondents, with a mean age of 45.6 ± 11.7 years, was interviewed. The distribution of EQ-5D-5L scores skewed towards full health with a skewness of −3.316. The overall correlation between EQ-5D-5L and SF-6D index scores was 0.46 (P < .001). The association of the 2 scales appeared stronger at the upper end. An intraclass correlation coefficient of 0.59 between the EQ-5D-5L and SF-6D meant a moderate correlation and indicated general agreement. The Bland–Altman plot displayed the same results as the scatter plot. The receiver operating characteristic curve showed that the AUC for the SF-6D was 0.776 (95% CI: 0.757, 0.796) and that for the EQ-5D-5L was 0.732 (95% CI: 0.712, 0.752) by the PCS-12, and it was 0.782 (95% CI: 0.763, 0.802) for the SF-6D and 0.690 (95% CI: 0.669, 0.711) for the EQ-5D-5L by the MCS-12. Our study demonstrated evidence of the performance of EQ-5D-5L and SF-6D index scores to measure health utility in people living with HIV/AIDS. There were significant differences in their performance. We preferred to apply the SF-6D to measure the health utility of PLWHIV during the combined antiretroviral therapy period. Our study has demonstrated evidence for instrument choice and preference measurements in PLWHIV under combined antiretroviral therapy.     

Daclizumab and Alemtuzumab as induction agents in adult intestinal and multivisceral transplantation: A comparison of two different regimens on 29 recipients during the early post-operative period

INTRODUCTION: Induction therapy has been recently adopted for intestinal transplant. PATIENTS AND METHODS: We compared during first 30 days post-transplantation 29 recipients, allocated in two groups, treated with Daclizumab (Zenapax) or Alemtuzumab (Campath-1H). RESULTS: During first month, 45% of Daclizumab recipients experienced six acute cellular rejections (ACRs) of mild degree, while 63% of them developed an infection requiring treatment. We found three acute cellular rejections in 17.6% of Alemtuzumab recipients, two with moderate degree; 64.7% of them required treatment for infection. DISCUSSION AND CONCLUSIONS: Graft and patient 3-years cumulative survival rate were not significantly different between groups. Alemtuzumab seems to offer a better immunosuppression during first month.     

The impact of HIV infection and men who have sex with men status on hepatitis A infection: The experience of two tertiary centres in Northern Italy during the 2017 outbreak and in the 2009‐2016 period

Hepatitis A is a self‐limiting infection representing the most common cause of viral hepatitis worldwide. Despite being a low incidence region, in the European Union, an increasing number of cases have been reported since summer 2016, resulting in a large outbreak in 2017, involving mainly men who have sex with men (MSM). Some reports described a different clinical course of hepatitis A virus in patients infected by human immunodeficiency virus (HIV) or MSM. We consecutively collected all the hospitalized cases of hepatitis A referred to two tertiary centres in Northern Italy in 2017 and retrospectively analysed the electronic records of the 2009‐2016 period (pre‐2017). We evaluated demographics data, risk factors, comorbidities and laboratory results to see whether MSM status or HIV infection influenced the disease. Overall, 117 cases were identified in 2017:107 (91%) were male, 78 reported themselves as MSM (66%) and 17 (14.5%) were infected by HIV. For the pre‐2017 period, 48 cases were reported: 29 (60%) were male and 3 (6.2%) were infected by HIV. After stratification for HIV infection, MSM status and occurrence period, no differences were found in aspartate aminotransferase, alanine aminotransferase, γ‐glutamyl transpeptidase; bilirubin, alkaline phosphatase and bilirubin values, hospitalization length, HIV viral load and CD4 + cells count. HIV‐positive patients presented a higher number of patients with INR > 1.5 at admission. MSM status and HIV infection did not affect neither the clinical course nor the severity of hepatitis A.     

Efficacy and safety of switching to bictegravir,emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials

Objectives

Data on switching to bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) in virologically suppressed Asian people living with HIV are limited. We performed a pooled analysis of virologically suppressed Asian participants from three international phase III trials to evaluate the efficacy and safety of switching to B/F/TAF.

Methods

Virologically suppressed people living with HIV were randomized to switch to B/F/TAF or to stay on baseline regimens. The primary endpoint was the proportion of participants with plasma HIV-1 RNA ≥50 copies/ml at week 48. We analysed the incidence of adverse events (AEs), laboratory abnormalities, and changes in relevant tolerability parameters through 48 weeks.

Results

Overall, 136 Asian participants were included. The proportions of participants with plasma HIV-1 RNA ≥50 copies/ml at week 48 were low in both arms (0% for B/F/TAF vs 1.4% for those who stayed on baseline regimens). Those who switched to B/F/TAF had virological suppression rates similar to those who stayed on baseline regimens (100% vs 95.9%, p = 0.2485), with no treatment-emergent resistance. Drug-related AEs occurred in three participants in each arm; none were serious. No participants discontinued the study drug because of AEs, and no deaths were observed. No significant differences were observed between the arms in the median changes in estimated glomerular filtration rate, body weight, and most lipid parameters. Switching from tenofovir disoproxil fumarate-containing regimens to B/F/TAF resulted in a significant decrease in tubular proteinuria compared with those who stayed on baseline regimens (p < 0.01).

Conclusions

Virologically suppressed Asian people living with HIV who switched to B/F/TAF maintained 100% virological suppression at week 48, with no treatment-emergent drug resistance and safety profiles comparable to those seen in people who stayed on baseline regimens.

Clinical Trial Number

ClinicalTrials.gov (NCT02603120, NCT02652624, and NCT02603107).     

The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection. A double-blind, placebo-controlled trial. The AIDS Clinical Trials Group

OBJECTIVE: To evaluate the efficacy and safety of zidovudine early in the treatment of human immunodeficiency virus type 1 (HIV) infection. DESIGN: A double-blind, randomized, placebo-controlled trial with subject stratification by pretreatment CD4 T lymphocyte counts. SETTING: Multicenter trial at AIDS Clinical Trial units. SUBJECTS: Seven hundred eleven subjects with mildly symptomatic HIV infection. INTERVENTION: Three hundred fifty-one subjects were assigned to placebo and 360 to zidovudine, 200 mg orally every 4 hours. The median duration of follow-up was 11 months. MEASUREMENTS AND MAIN RESULTS: Fifty-one subjects developed the acquired immunodeficiency syndrome (AIDS), advanced AIDS-related complex, or death as a first critical event. For the stratum of subjects with more than 200 but less than 500 CD4 T lymphocytes/mm3 before treatment, 34 events occurred in placebo recipients and 12 in zidovudine recipients (P = 0.0002; relative risk [RR] estimate, 3.23 [95% CI, 1.67 to 6.24]). For the stratum of subjects with 500 to 799 CD4 T lymphocytes/mm3 before treatment, 2 events occurred in placebo recipients and 3 in zidovudine recipients. Candidiasis at study entry independently increased the risk for having an event (P = 0.005; RR estimate, 2.3 [95% CI, 1.29 to 4.12]); HIV antigenemia at study entry also increased this risk (P = 0.01; RR estimate, 2.1 [95% CI, 1.2 to 3.8]). Significant differences between the treatment groups in CD4 T-lymphocyte counts occurred in subjects with more than 200 but less than 500 CD4 T lymphocytes/mm3 after 4 weeks of therapy (P = 0.002). Differences persisted through week 52. Less prominent changes occurred in subjects with 500 or more CD4 T lymphocytes/mm3. Serum levels of HIV antigen decreased significantly in zidovudine recipients. Serious anemia and neutropenia occurred in 5% and 4% of zidovudine recipients, respectively, and in 0% and 1% of placebo recipients, respectively. CONCLUSION: Zidovudine delayed progression of HIV disease and produced little toxicity in subjects with mildly symptomatic HIV disease and less than 500 CD4 T lymphocytes/mm3.     

Twenty-four-week safety and tolerability of nevirapine vs. abacavir in combination with zidovudine/lamivudine as first-line antiretroviral therapy: a randomized double-blind trial (NORA)

Objective To compare the safety/tolerability of abacavir and nevirapine in HIV‐infected adults starting antiretroviral (ARV) therapy in Uganda. Methods Twenty‐four‐week randomized double‐blind trial conducted with 600 symptomatic ARV‐naive adults with CD4 <200 cells/mm³ allocated to zidovudine/lamivudine plus 300 mg abacavir (A) and nevirapine placebo (n = 300) or 200 mg nevirapine (N) and abacavir placebo (n = 300) twice daily. The primary endpoint was any serious adverse event (SAE) definitely/probably or uncertain whether related to blinded nevirapine/abacavir. Secondary endpoints were adverse events leading to permanent discontinuation of blinded nevirapine/abacavir, and grade 4 events. Results Seventy‐two per cent participants were women; 19% had WHO stage 4 disease; the median age was 37 years (range 18–66); the median baseline CD4 count was 99 cells/mm³ (1–199). Ninety‐five per cent completed 24 weeks: 4% died and 1% were lost to follow‐up. Thirty‐seven SAEs occurred on blinded drug in 36 participants. Twenty events [6 (2.0%) abacavir, 14 (4.7%) nevirapine participants] were considered serious adverse reactions definitely/probably/uncertain whether related to blinded abacavir/nevirapine [HR = 0.42 (95% CI 0.16–1.09) P = 0.06]. Only 2.0% of abacavir participants [six patients (0.7–4.3%)] experienced a suspected hypersensitivity reaction (HSR). In total 14 (4.7%) abacavir and 30 (10.0%) nevirapine participants discontinued blinded abacavir/nevirapine (P = 0.02): because of toxicity (6A, 15N; P = 0.07, all rash/possible HSR and/or hepatotoxicity), anti‐tuberculosis therapy (6A, 13N), or for other reasons (2A, 2N). Conclusions There was a trend towards a lower rate of serious adverse reactions in Ugandan adults with low CD4 starting ARV regimens with abacavir than with nevirapine. This suggests that abacavir could be used more widely in resource‐limited settings without major safety concerns.