The Impact of Pharmacists' Interventions on the Quality of Life of HIV-TB Co-infection Outpatients in Indonesia: a Therapeutic Drug Monitoring (TDM) Approach

1. STUDY BACKGROUND

1.1 HIV and TB Diseases Human Immunodeficiency Virus (HIV) is a global health concern which the World Health Organization (WHO) estimates that 36.7 million people are living with HIV (PLHIV) with 1.1 million deaths of PLHIV in 2015, worldwide. Among them, there were 2.1 [1.8-2.4] million new HIV infections. Because of its immunosuppressive action, people living with HIV (PLHIV) are prone to be infected with opportunistic infections, such as tuberculosis (TB), pneumonia, and toxoplasmosis. TB itself is known as one of the main risks of death in PLHIV as it considerably accelerates the progression of HIV to AIDS by not only activating viral replication but also accentuating the decline in CD4 cell counts. It is also estimated that TB would affect one-third of the world's population and 9 million new cases of TB are discovered worldwide each year, with more than 1 million cases occurring in patients with HIV or AIDS. The incidence of TB globally has risen enormously since 1990, particularly in certain countries where there is a significant overlap between HIV and TB epidemics. The risk of developing TB is 29 (26-31) times higher in PLHIV than people without HIV as Mycobacterium tuberculosis and HIV are potentiating one another in accelerating the decrease of the immunological function and causing early death.

HIV treatments have been implemented since the first production of antiretroviral drugs and have been developing fast since because of the increasing number of HIV cases worldwide. The introduction of ARV reduces the development of TB, but this disease continues to occur among PLHIV. Antiretroviral and anti-TB drugs have their complex regimens, and the combination of these drugs in HIV-TB co-infection patients has caused increasingly even more complex regimens, potential toxicities, and issues of adherence due to potential interaction between antiretroviral and anti-TB medications. In HIV patients receiving regular antiretroviral drugs and becoming infected with TB, considerations on the alteration or discontinuation of antiretroviral drugs and selection of TB agents are based upon the efficacy of each selected drug, drug interactions, drug resistance, prevention of treatment failure, and patient adherence.

1.1.2 Pharmaceutical Care Interventions Such concerning and life-threatening diseases treatments have been massively conducted with a significant success worldwide, marked with the lower incidence of new cases of HIV and TB. However, the major diagnostic and therapeutic deficiencies remain. Health professionals, such as physicians, nurses, pharmacists, and other health professionals are required to ensure the success of HIV TB co-infection therapy based on the guidelines made by international organizations and local governments.

In the past few decades, there has been a shifting perspective of the pharmacist's role from the traditional role of dispensing medication to the patient-oriented perspective in collaboration with or without other health providers to achieve improvement of patient outcomes as well as the improvement of quality of life. The Pharmaceutical Care (PC) program which involves the specific role of a pharmacist has been implemented mostly in high-income countries to hospitalized- and out-patients. Several systematic reviews and meta-analysis are conducted to evaluate the impact of the patients-oriented intervention in any disease states;8-12 thus the thoroughly and rigorous reviews enable other researchers or health providers to assess and implement the most valid processes of pharmacist intervention in their setting.