The Use and Safety of Antiretroviral Medicines: Lessons from Ghana

Abstract

HIV/AIDS is a pandemic event with an estimated 33.2 million people living with the disease. Ghana is classified as having a generalised HIV epidemic with prevalence hovering around 2% in the last decade. This thesis documented outcomes and adverse events of Post-exposure HIV Prophylaxis (PEP) in Ghana, discussed the safety concerns of Pre-exposure HIV Prophylaxis (PrEP), documented adverse events associated with antiretroviral therapy (ART) and its effect on treatment modifications and evaluated the knowledge and attitudes of People Living with HIV (PLHIVs) to antiretrovirals in Ghana. We examined the characteristics and outcomes of occupational exposure to HIV and the utilization of a risk assessment system (RAS) based PEP among health workers (HCWs) and students (HCSs). A total of 260 and 35 exposures were reported by HCWs and HCSs respectively. Ward attendants reported the highest incidence rate of 6.46 of 100 person-years. None of the 289 individuals administered PEP seroconverted to HIV after 6 months of monitoring. The frequency of adverse events ranged from 28% to 96%, with highest rates observed in 28-day regimes. We recommend the additional use of the RAS as a complementary tool to assist in determining the immediate administration of PEP based on the potential risk of sero-conversion. Another study presented a review of the safety issues associated with tenofovir as PrEP. A total of 11 clinical trials on PrEP were reviewed and results indicate the main adverse effects with PrEP are gastro-intestinal in nature and graded below 2 for severity. Major adverse event concerns were renal, hepatic and bone toxicities which resolved after discontinuation of tenofovir use. We further assessed the association between documented adverse events (AEs) and ART modification. Adverse event was reported in 53% of patients with modified therapy and 4% in patients without treatment modifications. The most documented AE was anaemia (18%) and presence of AE was associated with an almost 3-fold increased risk of ART modification. We recommend that the management of AEs including dose adjustments and choice of appropriate regimen is a key strategy for improving adherence among PLHIV on ART in order to prevent therapy switches. We also examined the long term effects of tenofovir based regimen on renal profile in 300 PLHIV. At study end point 63 participants developed moderate impairment with 2.3% having severe impairment. We recommend an effective means of monitoring patients on TDF-based patients’ regimens in order to detect and manage early signs of renal impairment. Finally, we evaluated the knowledge and attitudes of patients to ART following routine adherence counselling and education. Majority of participants were rated high on knowledge of AEs and exhibited positive attitudes towards AEs. Continuous education and counselling of PLHIVs improves patients’ knowledge of AEs of ART and improves treatment outcomes. In conclusion, this thesis added to our understanding of the use and safety of antiretroviral medicines in Ghana. Collaboration between stakeholders is necessary to bring awareness of pharmacovigilance to health policy formulation and implementation to secure the safety of patients in the use of antiretroviral medicines.