Broadening access to tenofovir alafenamide for the treatment and prevention of HIV-1 infection.

INTRODUCTION: Tenofovir alafenamide (TAF), a prodrug of tenofovir, achieves higher intracellular concentrations of tenofovir-diphosphate and 90% lower plasma concentrations of tenofovir compared to tenofovir disoproxil fumarate (TDF). TAF is associated with improved renal and bone safety outcomes. AREAS COVERED: We review the efficacy and safety of TAF-containing regimens in adults and pediatrics. We highlight safety data during pregnancy, drug interactions during co-administration with tuberculosis treatment, and critical knowledge gaps to be addressed for the successful implementation of TAF in low- and middle-income countries. We performed a search on MEDLINE PubMed and conference websites for relevant articles published from January 2010 to March 2023. EXPERT OPINION: Current evidence demonstrates that TAF has similar efficacy and tolerability, superior bone and renal safety, and higher rates of dyslipidemia and weight gain, compared with TDF. However, there are several knowledge gaps, in specific sub-populations, that require action. Emerging data suggests that TAF is safe during pregnancy, although fuller safety data to support TAF use in pregnancy is needed. Similarly, there is a lack of evidence that TAF can be used in combination with rifamycin-based tuberculosis treatment in PWH and TB. Further studies are needed to fill knowledge gaps and support the wider rollout of TAF.

INSTIs for the management of HIV-associated TB (INSIGHT study): a phase 2b study to evaluate the efficacy, safety and pharmacokinetics of a combination of bictegravir, emtricitabine and tenofovir alafenamide fumarate for the treatment of HIV-1 infection in patients with drug-susceptible tuberculosis on a rifampicin-based treatment regimen: a phase 2b open-label randomised controlled trial.

INTRODUCTION: Cotreatment of HIV and tuberculosis (TB) reduces morbidity and mortality in coinfected patients. Availability of antiretroviral treatment (ART) drug options, including within drug classes, is important, particularly in high HIV/TB burden low and middle-income countries. METHODS AND ANALYSIS: This is a phase 2b, open-label, non-comparative randomised controlled trial to assess the antiretroviral activity of a fixed-drug, single tablet, combination of bictegravir (BIC) 50 mg/emtricitabine (FTC) 200 mg/tenofovir alafenamide (TAF) 25 mg (Biktarvy). The primary objective is to determine the efficacy, safety and pharmacokinetics of two times per day, coformulated BIC 50 mg/FTC 200 mg/TAF 25 mg in HIV-positive ART-naïve patients with TB who are receiving a rifampicin-based treatment regimen and to characterise viral suppression rates at week 24 through to week 48 in the BIC/FTC/TAF arm. We will enrol 120 patients randomised in a 2:1 ratio to the intervention or control arm of the study. A non-comparative contemporaneous control arm in which participants receive a dolutegravir-based regimen (standard of care) will also be enrolled. ETHICS AND DISSEMINATION: The University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC) and the South African Health Products Regulatory Authority (SAHPRA) have granted regulatory approval (trial reference numbers: BREC/00001300/2020 and SAHPRA 20200810). Trial results will be disseminated through conference presentations, peer-reviewed publications and the clinical trial registry. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov; Trial registration number: NCT04734652; South African National Clinical Trials Register (SANCTR DOH-27-012021-6789).

Assessment of knowledge of drug-food interactions among healthcare professionals in public sector hospitals in eThekwini, KwaZulu-Natal.

BACKGROUND: Foods and the nutrients they contain can interact with drugs and thereby interfere with their therapeutic safety and efficacy. Adequate knowledge of healthcare professionals (HCPs) about drug-food interactions can help in preventing potential drug-food interactions among patients. This study aimed to assess the knowledge of HCPs about common drug-food interactions. METHODS: A cross-sectional study was carried out among 459 HCPs from three public hospitals in eThekwini district, KwaZulu-Natal between November 2018, and January 2019. Informed consent was obtained from the HCPs, and a structured questionnaire was thereafter administered. Data were analysed using SPSS® version 25. Factors associated with knowledge of the HCPs were determined using logistic regression analysis. RESULTS: Of the 459 participants, 22.2% (n = 102) were doctors, 11.3% (n = 52) pharmacists, 63.8% (n = 293) nurses and 2.6% (n = 12) dietitians. Most of the HCPs were females 79.7% (n = 366), the mean age of the HCPs was 38.61±0.48. The knowledge score of the HCPs was 22.66±0.25 out of an overall score of 46. The HCPs poorly identified food types that interact with drugs and correct administration time of drugs relative to meals. Being a pharmacist (OR: 14.212, CI: 4.941-40.879, p<0.001), doctor (OR: 5.223, CI: 2.146-12.711, p<0.001), or a dietitian (OR: 5.476, CI: 1.103-27.191, p = 0.038) was associated with higher knowledge of drug-food interactions. CONCLUSION: The HCPs in this survey had low drug-food interaction knowledge. These findings suggest the need for additional training and educational courses for the HCPs on drug-food interactions.

Knowledge, attitudes and practices of healthcare professionals regarding drug-food interactions: a scoping review.

OBJECTIVES: Drug-food interactions (DFIs) are a problem in clinical practice as they can alter the bioavailability of drugs and nutrients and may lead to various adverse effects. Healthcare professionals (HCPs) play a significant role in counselling patients and preventing these interactions. Knowledge, attitudes and practices (KAPs) regarding DFIs are, therefore, vital to ensure that they carry out their role efficiently. This review maps evidence on KAPs of HCPs regarding DFIs and highlights gaps for further research. METHODS: A systematic literature search for the period from 1990 to 2018 was done using Google Scholar, PubMed and ScienceDirect. Keywords such as 'knowledge, attitudes, practices, healthcare professionals, drug-food interactions' in combination with the Boolean operator (AND) were used. Articles published only in English that described KAPs of HCPs relating to DFIs were included. KEY FINDINGS: Twelve studies were included in this review. Inadequate knowledge was observed among the HCPs as they were unable to identify important DFIs. The HCPs had a positive attitude towards acquiring knowledge, reporting and counselling patients on DFIs. Most of the medical residents felt that they were inadequately trained on DFIs and over half believed that DFIs were only slightly important in clinical practice. CONCLUSION: Deficits exist in the KAPs of HCPs regarding DFIs. An educational intervention targeting HCPs is recommended. Further research assessing the KAPs of the HCPs is required as the small number of studies conducted was a limitation.