Medication Adherence and Risk Factors for Non-adherence among Patients taking Highly Active Antiretroviral Therapy

Background: ART is a life long treatment and its effectiveness depends critically both on the efficacy of the antiretroviral drugs against the virus, and achieving a very high level of adherence (> 95 %) to the medications. Adherence poses a special challenge and requires commitment from the patient and the health care provider.Objectives: The study evaluated medication adherence, and identified risk factors for non-adherence in HIV-infected ART patients.Methods: In a cross-sectional survey, medication adherence of 118 HIV-infected ART patients who received pretreatment and ongoing adherence counseling and education for 6 months was evaluated using a self-administered studyspecific 16-item questionnaire. Self-reported adherence was calculated as the mean of patients' adherence to the medication schedule and the number of prescribed doses of medications missed. Chi-square statistics was used to test the association of adherence with occupation and education at 95 % CI.Results: The mean age of participants was 33.9 (95 % CI, 29.6-38.2) years; and 82.2 % of participants were aged 26-45years; 60.2 % females, 80.5 % attained secondary education at the least; and 77.1 % were employed. All participants reported been counseled on the benefits of ART and medication adherence at ART initiation. On assessment of participants' knowledge of the benefits of ART and medication adherence, 92.2 % were very knowledgeable, 2.9 %reported wrongly that ART is a cure for HIV. The self-reported adherence to medication schedule was 68.9 %(range: 0 % - 100 %), of which 83 (70.3 %) reported > 75 % adherence; while adherence to prescribed doses of medications was 89.2 % (range: 20 % - 100 %), of which 100 (84.7 %) participants reported > 80 % adherence. Mean self-reported adherence (±SD) was 79.1 % ± 14.4 %. Employment status was associated with poor adherence (P < 0.05), unlike the educational status. The major reasons reported for non-adherence were busy at work or school (33.1 %), forgetfulness (15.5 %), fasting (12.0 %), and travelled away from home (10.6%). Conclusion: The self-reported adherence was relatively poor compared to the desired value of > 95%. Employment status was associated with poor adherence and this may be corroborated by the major reason reported for non-adherence (busy at work or school). Routine adherence monitoring and multiple adherence interventions in clinical practice are recommended

Health-Related Quality of Life and CD4 Cells Status of Patients Receiving Antiretroviral Therapy in Nigeria

Background: The goals of antiretroviral therapy (ART) are to improve patient's health-related quality of life (HRQOL) and restore immunologic function among others. Objectives: The study evaluated HRQOL and CD4-cells response of HIV-infected patients at months 0 and 6 of receiving ART in Maitama District Hospital Abuja, Nigeria. Methods: HRQOL of a cohort of 150 HIV-infected patients was evaluated at months 0 and 6 of receiving ART using Medical Outcomes Study Short Form-36 (MOS SF-36) which has 8 domains. These include physical functioning, physically and emotionally related role limitations, social functioning, pain, energy/fatigue, emotional well-being and general health. A paired samples t-test was used to compare the HRQOL scores and CD4 cells count of participants at months 0 and 6. Wilcoxon's signed-ranks test was used to compare HRQOL of male and female participants. At two-tailed test, p value of <0.05 was considered significant. Results: The mean age (±SD) of the 150 participants at ART initiation was 34.3 ± 8.4 years; 59.3% were females. The mean (±SD) HRQOL of participants increased significantly from 71.9% ± 20.9 at ART initiation to 89.7% ± 10.6 after 6 months of ART (p<0.05). The change in all SF-36 domains was statistically significant (p<0.05) except for the domains of role limitation due to emotional problems, social functioning and pain. The improvement in the mental component score (MCS) was significant (p<0.05) unlike that of the physical component (PCS). The difference in the HRQOL of male and female participants at months 0 and 6 was not significant. The mean CD4 cell count (±SD) increased from 185.7 ±91.0 cells/mm3 at month 0 to 199.0 ±104.7 cells/mm3 after 6months of ART; though this increase was not statistically significant. Conclusion: There was significant improvement in the mean HRQOL scores of participants which was not associated with significant improvement in the CD4 cells status after six months of ART. The evaluation of HRQOL alongside the clinical and immunological parameters when monitoring treatment outcomes is recommended

Postmarketing in vitro/in vivo assessment of fixed dose combination products of first line antiretrovirals.

The purpose of this study was to evaluate the postmarket pharmaceutical equivalence, stability and bioequivalence of generic and innovator fixed dose combination products of lamivudine (3TC) and zidovudine (AZT) 150/300 mg tablets available in Nigeria. An isocratic HPLC-UV method was developed and validated for the quantitative determination of 3TC and AZT in human plasma and pharmaceutical samples. The model independent f(2) similarity factor was used to compare the dissolution profiles of the two products stored at accelerated and long-term stability conditions for 6 months. The f(2) values for 3TC and AZT in both products were found to be greater than 51. Also, the tablets were stable according to the USP potency and drug dissolution criteria with more than 80% of drug dissolution in 30 min indicating the pharmaceutical equivalence of the two products. The 90% confidence interval for the ratios of generic/innovator pharmacokinetic parameters for 3TC/AZT were 73.5-112.6/63.4-95.8 (C(max)); 68.5-105.6/68.0-114.8 (AUC(0-t)); and 64.2-106.2/80.1-120.3 (AUC(0-infinity)) respectively. The pharmacokinetic parameters failed to fully demonstrate bioequivalence between the products. The results underscored the importance of assessing the quality of the combination drug products that would ensure the safety and efficacy of the generic drug products available in the market.

Some compaction characteristics of the hot water leaf extract og Nauclea latifiola: a potential antimalarial agent.

This study aims to develop a suitable tablet dosage form of Nauclea latifolia, a potential antimalarial agent. The compaction characteristics of the oven dried water extract were studied using the Heckel equation. The mechanical properties of the compacts were also determined. This preliminary information will be useful in developing a suitable dosage form of the extract for use in the management of malaria. The results showed that N. latifolia extract exhibited high densification due to dye filling while the subsequent rearrangement of the granules did not contribute, significantly, to their densification. The granules had enhanced plasticity as shown by the low yield point, Py. The tablets produced from the extract had good mechanical properties, with hardness increasing via compression pressure while the friability decreased. However, the tablets had poor disintegration properties; it is concluded that while tablets of suitable physical properties can be produced from the extract, a disintegrant would need to be included in the formulation to ensure adequate drug release.