Browsing by Author "Naidoo, Anushka."

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Adherence challenges with drugs for pre-exposure prophylaxis to prevent HIV infection.
(Springer Verlag., 2013) Gengiah, Tanuja Narayansamy.; Moosa, Atika.; Naidoo, Anushka.; Mansoor, Leila Essop.
Background: There are 34 million people living with human immunodeficiency virus (HIV) worldwide and each year this number increases. Until a vaccine is discovered, the prevention of new HIV infections remains an urgent priority. Several trials studying the use of oral and topical agents for the prevention of HIV infection have already been completed. Adherence has proved to be a major challenge in achieving product efficacy. Aim of the review: To provide the clinical pharmacist with an understanding of the oral pre-exposure prophylaxis (PrEP) and topical microbicide product pipeline whilst emphasizing the critical importance of adherence to these drugs to avert HIV infection. Methods: PubMed/Medline and the web-based clinical trials registry (ClinTrials.gov) were searched using appropriate key words. For the time period 1992–2013—all phase II and phase III safety and effectiveness studies—testing agents for prevention of HIV infection were included in the review. Efficacy estimates, adherence estimates and reported challenges with adherence were extracted. Results: Twenty-four phase II and III clinical trials were found during review. Of these, 20 trials have been completed, and six trials show effectiveness in preventing HIV infection. The majority of the successful trials were to oral PrEP and to date only one microbicide trial of a vaginal antiretroviral microbicide gel has showed effectiveness. Adherence to study product played a major role in trial outcomes and there are several reasons for non-adherence. These include high on-trial pregnancy rates, low trial retention rates, low participant perception of risk, participant characteristics such as age <25 years, single status, migratory partners and trial fatigue. Study product characteristics such as dosage form, dosing interval, as well as associated adverse events may also influence adherence. Conclusion: Moderate to high adherence is critical to demonstrate efficacy of drugs for HIV prevention. For topical agents, intermittent use associated with coitus is more effective than daily use, particularly if sex is infrequent or partners migrant. For oral agents, daily use is effective but the motivation to use the drug and high risk perception is important. In serodiscordant couples, early initiation of highly active antiretroviral therapy in the infected partner affords almost complete protection to the negative partner. Drugs need to be tailored to the population at risk and availability of multiple drug options are important.
Changes to antiretroviral drug regimens during integrated TB-HIV treatment: results of the SAPiT trial.
(International Medical Press., 2014) Naidoo, Anushka.; Naidoo, Kogieleum.; Yende-Zuma, Fortunate Nonhlanhla.; Gengiah, Tanuja Narayansamy.; Padayatchi, Nesri.; Gray, Andrew Lofts.; Bamber, Sheila.; Nair, Gonasagrie.; Abdool Karim, Salim Safurdeen.
Background—Frequency of drug changes in combination antiretroviral therapy among patients starting both tuberculosis (TB) and human immunodeficiency virus (HIV) therapy, as a result of treatment-limiting toxicity or virological failure, is not well established. Methods—Patients in the Starting Antiretroviral Therapy at Three Points in Tuberculosis (SAPiT) trial were randomized to initiate antiretroviral therapy either early or late during TB treatment or after completion of TB treatment. Drug changes due to toxicity (defined as due to grade 3 or 4 adverse events) or virological failure (defined as viral load > 1000 copies/ml on two occasions, taken at least 4 weeks apart) were assessed in these patients. Results—A total of 501 TB-HIV co-infected patients were followed for a mean of 16.0 (95% confidence interval (CI): 15.5 to 16.6) months after antiretroviral therapy (ART) initiation. The standard first-line ARVs used, were efavirenz, lamivudine and didanosine. Individual drug switches for toxicity occurred in 14 patients (incidence rate: 2.1 per 100 person-years; 95% (CI): 1.1 to 3.5), and complete regimen changes due to virological failure in 25 patients (incidence rate: 3.7 per 100 person-years; CI: 2.4 to 5.5). The most common treatment limiting toxicities were neuropsychiatric effects (n=4; 0.8%), elevated transaminase levels and hyperlactatemia (n= 3; 0.6%), and peripheral neuropathy (n=2; 0.4%). Complete regimen change due to treatment failure was more common in patients with CD4+ cell count <50cells/mm3 (p<0.001) at ART initiation and body mass index greater than 25 kg/m2 (p=0.01) at entry into the study. Conclusion—Both drug switches and complete regimen change were uncommon in patients cotreated for TB-HIV with the chosen regimen. Patients with severe immunosuppression need to be monitored carefully, as they were most at risk for treatment failure requiring regimen change.
Early experiences with Isoniazid Preventive Therapy roll-out in an ART programme : a pharmacist's perspective.
(2016) Maharaj, Bhavna.; Yende-Zuma, Fortunate Nonhlanhla.; Naidoo, Anushka.; Gengiah, Santhanalakshmi.; Naidoo, Kogieleum.
Tuberculosis (TB) remains the leading cause of mortality amongst people infected with Human Immunodeficiency Virus (HIV). Additionally, TB recurrence after successful treatment completion occurs more frequently amongst HIV positive people. Isoniazid provided as part of isoniazid preventive therapy (IPT) has been the gold standard of TB preventive therapy provision for the last few decades. IPT has been recommended by the World Health Organisation (WHO) and implemented by national health programmes in countries across the world. Despite global efforts and campaigns to promote IPT, uptake still remains a challenge and, progress in the operational scale- up of IPT is slow. Both international and in-country guidelines have advanced to recommending the use of IPT in HIV infected patients who have previously been treated for TB because these patients remain at risk for recurrent TB especially in TB endemic settings. However, there still remains a paucity in data on the successful programmatic use of IPT secondary to previous cured TB among HIV infected patients and is the focus of the current analysis from a pharmacists’ perspective. Methods: A retrospective secondary analysis was conducted from October 2009 to October 2013, amongst HIV infected patients, previously treated for TB, accessing HIV care at the urban CAPRISA clinical research clinic in Durban, South Africa. The aim of the study was to evaluate the implementation of Isoniazid Preventive Therapy (IPT) within the parent study titled “TB recurrence upon treatment with HAART” (TRuTH). Data was collected on IPT uptake, course completion, drug toxicity, treatment interruption, and the occurrence of incident TB either during treatment or post IPT completion. The multidisciplinary team approach in providing IPT to at risk HIV infected patients, including the specific role of the pharmacist, was also assessed. Results: There were 402 patients enrolled in the parent study. Of these 344 (85.6%) were eligible to receive IPT and of whom 212 (61.6%) initiated IPT. Among those that commenced IPT, 184 (86.8%) completed the six-month course, 24 (11.3%) permanently discontinued IPT and of these, 3.8% discontinued due to side effects. More women (n=130; 61.3%) were initiated on IPT (p=0.001) than men. Overall median adherence to IPT was 97.6% (IQR: 94.2 - 99.4). There were 22 cases of incident TB in this cohort: 13 occurred prior to IPT and nine after IPT (incidence rate ratio 0.67; 95% CI 0.29- 1.58; p=0.362). CONCLUSIONS: Overall, we demonstrated a successful IPT roll-out in a high TB endemic setting with good uptake of IPT, minimal course interruptions or side effects reported. IPT is a safe and tolerable TB prevention intervention within ART programmes and importantly amongst patients on ART with previous TB treatment experience. The pharmacist played an important role in continuum of care in IPT provision within an ART programme. This role included ensuring stable supply chain management, supporting clinic staff in monitoring safe IPT use and provided data on IPT course completion rates
Effect of rifampicin and efavirenz on moxifloxacin concentrations when co-administered in patients with drug-susceptible TB.
(Oxford University Press., 2017) Naidoo, Anushka.; Chirehwa, Maxwell.; McIlleron, Helen.; Naidoo, Kogieleum.; Essack, Sabiha Yusuf.; Yende-Zuma, Fortunate Nonhlanhla.; Kimba-Phongi, Eddy.; Adamson, John.; Govender, Katya.; Padayatchi, Nesri.; Denti, Paolo.
Abstract available in pdf.
Implementing isoniazid preventive therapy in a tuberculosis treatment-experienced cohort on ART.
(International Union against Tuberculosis and Lung Disease., 2017) Maharaj, Bhavna.; Gengiah, Tanuja Narayansamy.; Yende-Zuma, Fortunate Nonhlanhla.; Gengiah, Santhanalakshmi.; Naidoo, Anushka.; Naidoo, Kogieleum.
Abstract available in pdf.
Integration of antiretroviral therapy with tuberculosis treatment.
(Massachusetts Medical Society., 2011) Abdool Karim, Salim Safurdeen.; Naidoo, Kogieleum.; Grobler, Anna Christina.; Padayatchi, Nesri.; Baxter, Cheryl.; Gray, Andrew Lofts.; Gengiah, Tanuja Narayansamy.; Gengiah, Santhanalakshmi.; Naidoo, Anushka.; Jithoo, Niraksha.; Nair, Gonasagrie.; El-Sadr, Wafaa M.; Friedland, Gerald H.; Abdool Karim, Quarraisha.
Background. We previously reported that integrating antiretroviral therapy (ART) with tuberculosis treatment reduces mortality. However, the timing for the initiation of ART during tuberculosis treatment remains unresolved. Methods. We conducted a three-group, open-label, randomized, controlled trial in South Africa involving 642 ambulatory patients, all with tuberculosis (confirmed by a positive sputum smear for acid-fast bacilli), human immunodeficiency virus infection, and a CD4+ T-cell count of less than 500 per cubic millimeter. Findings in the earlier- ART group (ART initiated within 4 weeks after the start of tuberculosis treatment, 214 patients) and later-ART group (ART initiated during the first 4 weeks of the continuation phase of tuberculosis treatment, 215 patients) are presented here. Results. At baseline, the median CD4+ T-cell count was 150 per cubic millimeter, and the median viral load was 161,000 copies per milliliter, with no significant differences between the two groups. The incidence rate of the acquired immunodeficiency syndrome (AIDS) or death was 6.9 cases per 100 person-years in the earlier-ART group (18 cases) as compared with 7.8 per 100 person-years in the later-ART group (19 cases) (incidence-rate ratio, 0.89; 95% confidence interval [CI], 0.44 to 1.79; P = 0.73). However, among patients with CD4+ T-cell counts of less than 50 per cubic millimeter, the incidence rates of AIDS or death were 8.5 and 26.3 cases per 100 person-years, respectively (incidence-rate ratio, 0.32; 95% CI, 0.07 to 1.13; P = 0.06). The incidence rates of the immune reconstitution inflammatory syndrome (IRIS) were 20.1 and 7.7 cases per 100 person-years, respectively (incidence-rate ratio, 2.62; 95% CI, 1.48 to 4.82; P<0.001). Adverse events requiring a switching of antiretroviral drugs occurred in 10 patients in the earlier-ART group and 1 patient in the later-ART group (P = 0.006). Conclusions. Early initiation of ART in patients with CD4+ T-cell counts of less than 50 per cubic millimeter increased AIDS-free survival. Deferral of the initiation of ART to the first 4 weeks of the continuation phase of tuberculosis therapy in those with higher CD4+ T-cell counts reduced the risks of IRIS and other adverse events related to ART without increasing the risk of AIDS or death.
Measuring adherence by visual inspection of returned empty gel applicators in the CAPRISA 004 microbicide trial.
(Springer., 2014) Gengiah, Tanuja Narayansamy.; Mansoor, Leila Essop.; Upfold, Michele.; Naidoo, Anushka.; Yende-Zuma, Fortunate Nonhlanhla.; Kashuba, Angela D. M.; Abdool Karim, Quarraisha.; Abdool Karim, Salim Safurdeen.
Abstract not available in pdf.
Monitoring microbicide gel use with real-time notification of the container’s opening events : results of the CAPRISA Wisebag study.
(Springer., 2014) Gengiah, Tanuja Narayansamy.; Upfold, Michele.; Naidoo, Anushka.; Mansoor, Leila Essop.; Feldblum, Paul J.; Abdool Karim, Quarraisha.; Abdool Karim, Salim Safurdeen.
Accurate estimation of the effectiveness of a microbicide for HIV prevention requires valid measurement of adherence to product use. A microbicide gel applicator container (Wisebag), fitted with cell phone technology to transmit opening events and text message reminders, was developed to monitor each opening event of the container as a proxy for gel use and adherence. Ten women were enrolled in a pilot study and followed for up to 4 months. Wisebag opening (WBO) dates and times were recorded and correlated with self-reported sex acts and gel applicator returns. During the 33 monthly follow-up visits, 47.8% (77/161) of the recorded number of WBO events were concordant with the number of empty (used) applicators returned. The discrepancies were likely due to removal of more than one applicator during a single opening event. When the date and time of the WBO event data was assessed in relation to three different self-report adherence measures, agreement was fairly modest. The Wisebag was found to be acceptable as a storage container and the cell phone reminders generated were useful in supporting the dosing strategy. We recommend that the Wisebag be considered for larger scale and lengthier testing in microbicide trials.