Bio-analytical Assay Methods used in Therapeutic Drug Monitoring of Antiretroviral Drugs-A Review

Background: Several clinical trials, as well as observational statistics, have exhibited that the advantages of antiretroviral [ARV] treatment for humans with Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome HIV/AIDS exceed their risks. Therapeutic drug monitoring [TDM] plays a key role in optimization of ARV therapy. Determination of ARV's in plasma, blood cells, and other biological matrices frequently requires separation techniques capable of high effectiveness, specific selectivity and high sensitivity. High-performance liquid chromatography [HPLC] coupled with ultraviolet [UV], Photodiode array detectors [PDA], Mass spectrophotometer [MS] detectors etc. are the important quantitative techniques used for the estimation of pharmaceuticals in biological samples. Objective: This review article is aimed to give an extensive outline of different bio-analytical techniques which have been reported for direct quantitation of ARV's. This article aimed to establish an efficient role played by the TDM in the optimum therapeutic outcome of the ARV treatment. It also focused on establishing the prominent role played by the separation techniques like HPLC and UPLC along with the detectors like UV and Mass in TDM. Methods: TDM is based on the principle that for certain drugs, a close relationship exists between the plasma level of the drug and its clinical effect. TDM is of no value if the relationship does not exist. The analytical methodology employed in TDM should: 1) distinguish similar compounds; 2) be sensitive and precise and 3) is easy to use Results: This review highlights the advancement of the chromatographic techniques beginning from the HPLC-UV to the more advanced technique like UPLC-MS/MS. TDM is essential to ensure adherence, observe viral resistance and to personalize ARV dose regimens. It is observed that the analytical methods like immunoassays and liquid chromatography with detectors like UV, PDA, Florescent, MS, MS/MS and Ultra performance liquid chromatography (UPLC)-MS/MS have immensely contributed to the clinical outcome of the ARV therapy. Assay methods are not only helping physicians in limiting the side effects and drug interactions but also assisting in monitoring patient's compliance. Conclusion: The present review revealed that HPLC has been the most widely used system irrespective of the availability of more sensitive chromatographic technique like UPLC.VRAID (ex DIPUC

"Every drug goes to treat its own disease…" - a qualitative study of perceptions and experiences of taking anti-retrovirals concomitantly with anti-malarials among those affected by HIV and malaria in Tanzania.

BACKGROUND: Little is known about how people living with human immunodeficiency virus (HIV) experience malaria and the concomitant use of anti-malarial treatments with anti-retrovirals (ARVs). An understanding of how patients make sense of these experiences is important to consider in planning and supporting the clinical management and treatment for co-infected individuals. METHODS: A qualitative study was conducted in Tanzania alongside a clinical trial of concomitant treatment for HIV and malaria co-infection. Focus group discussions were held with people receiving treatment for HIV and/or malaria, and in-depth interviews with health workers responsible for HIV care and members of the clinical trial team. Data were analysed inductively to identify themes and develop theoretical narratives. RESULTS: Results suggest that people living with HIV perceived malaria to be more harmful to them due to their compromised immune status but saw the disease as unavoidable. For those enrolled in the clinical controlled study, taking anti-malarials together with ARVs was largely seen as unproblematic, with health workers' advice and endorsement of concomitant drug taking influential in reported adherence. However, perceptions of drug strength appeared to compel some people not enrolled in the clinical study to take the drugs at separate times to avoid anticipated harm to the body. CONCLUSIONS: Management of HIV and malaria concurrently often requires individuals to cross the domains of different disease programmes. In the context of a trial concerned with both diseases, patients experienced the support of clinicians in guiding and reassuring them about when and how to take drugs concomitantly. This points towards the need to continue to strive for integrated care for patients with HIV

The Participation Of Private Healthcare Facilities In Pharmacovigilance Activities: A Case Study In Tanzania Mainland

Abstract Background: Poor quality products, adverse drug reactions (ADRs) and medication errors (ME) are reported to negatively influence health care cost, patients’ treatment outcomes and quality of life. One way which can help in detection and prevention of their occurrence is through spontaneous reporting of these effects/events to the regulatory bodies. Despite the efforts done by regulatory bodies in different countries including Tanzania, the rate of reporting has remained low. This study therefore, assessed the participation of private healthcare facilities in pharmacovigilance (PV) activities in Tanzania Mainland. Methods: A descriptive cross sectional study was conducted in selected regions in Tanzania from December 2017 to June 2018. A total of 169 healthcare facilities and 192 healthcare professionals were involved. Data was collected using questionnaires and standard checklist. Results: Only (17%) of the respondents had good knowledge on PV activities and only (29.7%) of the participants had attended training on PV. Over 50% of respondents were not aware that PV activities reports are to be sent to a National pharmacovigilance center. Majority (89.7%) of the healthcare facilities assessed had no system for monitoring and reporting PV activities. About (55.7%) of the respondents said that they had observed ADRs in patients while (27.6%) had detected poor quality products and (51.1%) spotted medication errors in their practice, but none of them sent a report to the National pharmacovigilance center. Lack of PV tools (60.9%), poor knowledge on reporting procedures (69.8%) and lack of feedback and weak supervision from Tanzania Medicines and Medical Devices Authority (TMDA (93.3%) and (9.4%), respectively were the major obstacles for carrying out PV activities. Of the 47 respondents whereas, their healthcare facilities had systems for monitoring and reporting PV activities had a view that attending more training (74.5%), increase availability of PV tools (10.6%), frequent supervision from TMDA (12.8%), and inclusion of PV training in undergraduate and postgraduate training curricula (2.1%) may improve involvement in pharmacovigilance activities Conclusions: Majority of private healthcare facilities participated poorly in PV activities, because of lack of pharmacovigilance training, knowledge on reporting and unavailability of systems and tools for monitoring and reporting on pharmacovigilance activities.</jats:p

Availability of human immunodeficiency virus prevention services in secondary schools in Kabarole District, Uganda

This study was to assess the level of availability of HIV prevention strategies in secondary schools in Kabarole district, Uganda in order to inform the design of interventions to strengthen HIV Prevention and psychosocial support.The aim of this study was to assess the level of availability of HIV prevention strategies in secondary schools in Kabarole district, Uganda in order to inform the design of interventions to strengthen HIV Prevention and psychosocial support. Quantitative and qualitative research methods were used in eight secondary schools in Kabarole district to establish available HIV prevention and psychosocial support services. Questionnaires were administered to 355 students 12-24 years old. In addition, 20 Key Informant interviews were held with education service providers. Quantitative data was analyzed using Epi-data and qualitative data were analyzed by thematic content analysis. Seven of the eight schools had at least one HIV prevention strategy. Two teachers in each of the five schools had been trained in HIV prevention. No school had a nurse trained in HIV prevention, care and support. Education service providers had limited knowledge of HIV prevention support and care of students living with HIV. We found out that students had knowledge on how one can acquire HIV. HIV prevention services reported by students in schools included: talks from teachers and guests (19%), drama with HIV prevention related messages (16%), peer education clubs (15%), workshops and seminars on HIV (8%), sensitization about HIV/AIDS (7%), guidance and counseling (6%), talking compounds- (5%), abstinence talks (6%), keeping students busy in sports (4%), straight talk (4%). Sixty three percent reported receiving HIV reading materials from various sources. Preventing HIV infection among students in schools is still demanding with limited interventions for students. Efforts to support school interventions should focus on including HIV Prevention in the school curriculum, working with peer educators as well as education service providers who spend much of the time with the students while at school