Investigations into the Risk of Reproductive Toxicity Following Exposure to Highly Active Anti-Retroviral Drugs in Rodents.

With the introduction of Highly Active Antiretroviral Therapy (HAART), there has been drastic decline in morbidity and mortality associated with HIV/AIDS. However, many patients experience adverse drug reactions perhaps due to the inherent toxic nature of HAART. The possible toxic effect of HAART (combination ARVs) on reproduction and sexual dysfunction in seropositive HIV patients remains a subject of intense research. This study was designed to investigate the toxic effects of HAART on the reproductive hormones and organs of male and female rats. Sexually mature adult male and female rats were administered therapeutic doses of single and combination antiretroviral drugs for 48 days and thereafter sacrificed under anaesthesia. Morphological and histopathological examination of the testes and ovaries were carried out. Serum biochemical assay, semen quality analysis and hormonal assays were also conducted using standard methods. Results show significant (p < 0.05) reductions in the weight of testes and epididymis across all groups versus control; sperm count and motility were also significantly reduced in the test groups while hormonal analysis in males revealed significant reductions in LH, FSH and Testosterone. In the females, there was a significant (p < 0.05) reduction in the number of ovarian follicles, prolactin, estrogen and progesterone. We thus conclude that the administration of single and combined antiretroviral drugs have potential reproductive toxic effects.

A prospective study of adverse events to antiretroviral therapy in HIV- infected adults in Ekiti State, Nigeria.

OBJECTIVES: Highly active antiretroviral therapy (HAART); the-current standard of antiretroviral therapy for Human Immunodeficiency Virus (HIV) infected persons, has been documented to drastically, reduce the number of cases of Acquired Immune Deficiency Sypdrome (AIDS). However, adverse. events are a challenge to the use of HAART. This study intends to determine the nature and incidence of suspected advcrse events to prescribed anti retroviral drugs in treatment centers in Ekiti State. METHOD: One hundred and twenty participants were enrolled and followed up over a period of six months. At each clinic visit, there was an administration of a detailed interviewer questionnaire that was completed by the attending pharmacist together with the participant. The form is designed to obtain information on the demographics of the patients, WHO clinical stage of their HIV infection, HAART regimen for the patients, and suspected adverse events associated with the antiretroviral drugs used by the patients. RESULTS: Tenofovir/Lamivudine/Eifavirenz (72.5%), Zidovudinc/Lamiv.udin/Nevirapine (16.7%), Zidovudine/Lamivudiine/ElafIvirenz (6.7%), Tenofovir/ Lamivudine/Nevirapine (3.3%), and Abacavir/ Lamivudine/Nevirapine (0.8%) were the HAART regimens prescribed to the patients. About half (57%) of the participants reported clinical adverse events; 92% of which were reported within two weeks of HAART initiation. Most of the reported adveise events were nausea (14.5%), abdominal discomfort (8.2%), and insomnia (7.5%). A few (6%) of those who reported adverse events required regimen switch or drug substitution. CONCLUSIONS: Antiretroviral drugs exposure often presents with adverse events, an observation similar to other studies. Most of the clinical adverse events were not severe or life threatening.

Interplay between antiretroviral therapy and oxidative stress in HIV seropositive patients.

BACKGROUND: HIV infection results in a decline of CD4+ T-cells count and ultimately results in qualitative impairments of CD4+ T-cell function. Antiretroviral therapy results in an increase in the number of CD4+ cells and the functional reconstitution of the immune system. However, patients on therapy commonly experience adverse effects; management of HIV infection thus becomes a balancing act between the benefits of HIV suppression and the risks of drug toxicity with Highly Active Antiretroviral Therapy (HAART). Purpose and Findings: This review intended to look into the relationship between adverse effects with HAART in relation to its induction of oxidative stress in the host. From literature,. HAART has been shown to induce oxidative stress by several biochemical mechanisms. However, the induction of oxidative stress by HAART is minimal compared to HIV induction of oxidative stress-in the host. The use of HAART in the management of HIV-AIDS thus remains inevitable and the combination with exogenous antioxidants is advocated. Exogenous antioxidants mop up infection induced reactive oxygen species (ROS), and may also be beneficial in ameliorating some of the adverse effects induced by HAART. CONCLUSION: Further review on individual adverse effects of ART is recommended and our ongoing research on the teratogenic potentials of HAART will also be very relevant on this subject.

A study on pharmacovigilance of herbal medicines in Lagos West Senatorial District, Nigeria.

BACKGROUND: There is an increasing use of herbal products and herbal medicines globally with the belief that herbal medicines are always 'safe' and carry no risk because they are from natural sources. However, there are concerns regarding medicinal plants and their ability to produce adverse effects. The growing herbal medicine usage has increased the need to monitor the safety of herbal medicines. Thus, the recommended approach by the World Health Organization (WHO) is to include herbal medicines in existing national pharmacovigilance systems. OBJECTIVE: This study aimed to determine the knowledge of pharmacovigilance of herbal medicines amongst herbal medicine practitioners. METHODS: The study was carried out in Lagos West Senatorial District of Lagos State, Nigeria. Three categories of practitioners (378 respondents) were engaged and they include Traditional Herbal Sellers, Natural Health Practitioners and Pharmacists. RESULTS: The results showed that herbal medicines are commonly recommended for malaria, typhoid, diabetes and fever. 281 (74.3%) of the respondents claimed that herbal medicines have no adverse effects and only 91 (24.1%) of the respondents said there were some adverse effects reported by the users. Adverse effects reported include nausea, diarrhoea and weight loss. Amongst those that received reports of adverse effects, only 19 (20.9%) documented these reported adverse effects; none of these documentations were forwarded to the regulatory bodies or national pharmacovigilance centre in Nigeria. CONCLUSIONS: These results showed inadequate adverse effects monitoring (Pharmacovigilance) amongst the practitioners and underscore the necessity to educate and enlighten herbal medicine practitioners on the need for pharmacovigilance activity of herbal products.

Traditional medicinal plants in Nigeria--remedies or risks.

ETHNO-PHARMACOLOGICAL RELEVANCE: Soil pollution due to increasing industrialization is a reality that is taking its toll on mankind today. Considering the population of people that use herbal remedies especially in developing countries and the discharge of industrial waste on surrounding herbal vegetation, it is imperative to determine the heavy metals contamination in some commonly used medicinal plants. MATERIALS AND METHODS: Representative samples of five medicinal plants Ageratum conyzoides, Aspilia africana, Alchornea cordifolia, Amaranthus brasiliensis and Chromolaena odorata were collected from Ikpoba-Okha L.G.A, Edo State Nigeria, around a paint company and another set of same plants were collected from a non-polluted source. Dried leaves and roots of collected plants were digested and analyzed using Atomic Absorption Spectrophotometer (AAS) for the presence of Lead (Pb), Cadmium (Cd), Chromium (Cr), Nickel (Ni) and Zinc (Zn). Soil samples from polluted and non-polluted areas were also analyzed to ascertain the levels of these heavy metals in the environment. RESULTS: Results show that the concentrations of these heavy metals in the leaves and roots of plants collected from polluted soil were significantly higher than those obtained from unpolluted soil. Correspondingly heavy metal concentrations were significantly higher in polluted than in unpolluted soil samples. CONCLUSION: As part of continuing effort in the standardization of traditional remedies, environmental contamination control and abatement is evident. The source of medicinal plants/herbs should also be a cause for concern since the toxicity of medicinal plants is sometimes associated with environmental sources of the plants.