METHODS: We did this randomised, double-blind, active-controlled, phase 3, non-inferiority trial at 46 outpatient centres in China, Dominican Republic, Hong Kong, Japan, Malaysia, South Korea, Spain, Taiwan, Thailand, Turkey, and the USA. Eligible participants were treatment-naive adults (aged ≥18 years) with plasma HIV-1 RNA of at least 500 copies per mL and plasma HBV DNA of at least 2000 IU/mL. Participants were randomly assigned (1:1) to receive daily oral bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg, or dolutegravir 50 mg, emtricitabine 200 mg, and tenofovir disoproxil fumarate 300 mg, each with corresponding matching placebo. Randomisation was stratified by hepatitis B e antigen (HBeAg) status (positive vs negative), HBV DNA (<8 vs ≥8 log10 IU/mL), and CD4 count (<50 vs ≥50 cells per μL) at screening. All investigators, participants, and staff providing treatment, assessing outcomes, and collecting data were masked to study treatment for 96 weeks. Coprimary endpoints were the proportion of participants with plasma HIV-1 RNA less than 50 copies per mL (defined by the US Food and Drug Administration snapshot algorithm) and plasma HBV DNA less than 29 IU/mL (using the missing-equals-failure approach) at week 48, with a prespecified non-inferiority margin of -12%. Coprimary endpoints were assessed in the full analysis set, which included all randomly assigned participants who received at least one dose of study drug and had at least one post-baseline HIV-1 RNA or HBV DNA result while on study drug. Safety endpoints were assessed in all randomly assigned participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT03547908.
FINDINGS: Between May 30, 2018 and March 16, 2021, 381 participants were screened, of whom 243 initiated treatment (121 in the receive bictegravir, emtricitabine, and tenofovir alafenamide group; 122 in the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group). At week 48, both endpoints met the criteria for non-inferiority: 113 (95%) of 119 participants in the bictegravir, emtricitabine, and tenofovir alafenamide group and 111 (91%) of 122 participants in the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group had HIV-1 RNA less than 50 copies per mL (difference 4·1, 95% CI -2·5 to 10·8; p=0·21), and 75 (63%) of 119 participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus 53 (43%) of 122 participants in the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group had HBV DNA suppression (difference 16·6, 5·9 to 27·3; nominal p=0·0023). Drug-related adverse events up to week 96 occurred in 35 (29%) of 121 participants in the bictegravir, emtricitabine, and tenofovir alafenamide group and 34 (28%) of 122 participants in the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group. One (1%) of 121 participants in the bictegravir, emtricitabine, and tenofovir alafenamide group reported a serious adverse event (cryptococcal meningitis attributed to immune reconstitution inflammatory syndrome) that was deemed to be treatment-related.
INTERPRETATION: Coformulated bictegravir, emtricitabine, and tenofovir alafenamide is an effective therapy for adults with HIV-1 and HBV coinfection starting antiviral therapy.
FUNDING: Gilead Sciences.
DESIGN: A cross sectional study was conducted among 267 elderly people, 54 care givers and 66 health professionals in two rural areas of Peninsular of Malaysia (i.e Sabak Bernam, Selangor and Kuala Pilah, Negeri Sembilan). Information on nutritional knowledge was obtained from an interview based questionnaire for older subjects and caregiver and through self administered questionnaire from the health professionals. Anthropometric and functional measurements were also conducted among elderly subjects.
RESULTS: It was found that the elderly subjects had poor nutritional knowledge with 43.8% of them classified as having unsatisfactory nutritional knowledge, followed by moderately satisfactory (33.7%), very unsatisfactory (15.7%) and good (6.7%). Talks, counselling sessions with health professionals and electronic media such as television and radio were the most preferred nutrition education sources among elderly subjects and their care givers. The majority of health professionals studied (98.5%) had good nutritional knowledge. Although most of them (93.6%) were involved in management of the elderly, only 45.5% incorporated nutritional information component in this activity. Most of the health professionals used the guidelines for management of elderly patients (63.6%). However, nutritional knowledge was very minimal in these guidelines. Multiple regression analysis indicated that 'level education', involvement in 'social activities', presence of 'hearing problems', the Instrumental Activities of Daily Living (IADL) score, having previous 'nutritional information' and 'participation in healthy eating programme' were the major predictors of nutritional knowledge score among elderly subjects.
CONCLUSION: Based on the above findings it is thus, imperative that an appropriate nutritional intervention package and programme be developed so as to help improve nutritional knowledge and subsequently the nutritional status of the rural elderly Malays.
METHODS: The scale development involved three phases: i) generation of domains based on the literature, ii) generation of sub-domains based on literature review and Islamic panel survey, and iii) generation of items.
RESULTS: Preliminary version of IPM3P consists of 59 items was produced, representing three domains: Obligation (18 items), Practice (21 items), and Difficulty (20 items), and seven sub-domains ('Ibadah', 'Aqidah', 'Muamalat', 'Tasawwuf', 'Akhlak','Da'wah', and 'Sirah').
CONCLUSION: The preliminary version of IPM3P needs to be psychometrically tested. This pioneering study may become an impetus towards more research pertaining to understanding the effect of hearing loss towards religious life in the future in Malaysia.
METHODS: The preliminary version of IPM3P that is used to investigate the perception of Muslim adults with hearing impairment towards Islamic understanding and practice has been tested in this study. The preliminary version of IPM3P consists of three domains (obligation, practice, and difficulty) with 59 items in total. Four phases of validity and reliability testing involved were: i) Content validation, ii) Pretesting, face validity and proofreading, iii) Pilot study, and iv) Psychometric evaluation.
RESULTS: The final version of IPM3P consists of 36 items. The findings from the present study suggest that the final version of IPM3P has excellent psychometric properties manifested by: i) good content validity, ii) excellently pretested, iii) good face validity, iv) good construct validity shown by principal component analysis and convergent validity, and v) good discriminant validity showed by divergent validity.
CONCLUSION: IPM3P shows good potential to be used as a tool in investigating perception of Muslim adults towards Islamic understanding and practice.