Bharat Rewari

Utility of the point of care CD4 analyzer, PIMA, to enumerate CD4 counts in the field settings in India

BackgroundIn resource limited settings non-availability of CD4 count facility at the site could adversely affect the ART roll out programme. Point of care CD4 enumerating equipments can make the CD4 count available at the site of care and improve the patients’ management considerably. This study is aimed at determining the utility of a Point of Care PIMA CD4 analyzer (Alere, Germany) in the field settings in India.MethodThe blood samples were collected from 1790 participants at 21 ART centers from different parts of the country and tested using PIMA and the reference methods (FACSCalibur, FACSCount and CyFlow SL3). The paired finger prick and venous blood samples from 175 participants were tested by the PIMA CD4 Analyzer and then by FACSCalibur.ResultThe CD4 counts obtained by PIMA CD4 analyzer showed excellent correlation with the counts obtained by the reference methods; for venous blood the Pearson’s r was 0.921, p < 0.001 and the relative bias was 0.2% (range: -42 to 42%) and for finger prick samples, the Pearson’s r was 0.856 and the relative bias was −9.1% (range: -46% to 27%). For CD4 ranges; <250, 251–350, 351–500 and >500 cells/mm3, the differences in the median CD4 counts obtained by the reference method and the PIMA analyzer were not significant (P > 0.05) and the relative bias were low (−7 to 5.1%). The Intermachine comparison showed variation within the acceptable limit of%CV of 10%.ConclusionIn the field settings, the POC PIMA CD4 analyzer gave CD4 counts comparable to the reference methods for all CD4 ranges. The POC equipment could identify the patients eligible for ART in 91% cases. Adequate training is necessary for finger prick sample collection for optimum results. Decentralization of CD4 testing by making the CD4 counts available at primary health centers, especially in remote areas with minimum or no infrastructure would reduce the missed visits and improve adherence of the patients.

Survival probability and predictors of mortality and retention in care among patients enrolled for first-line antiretroviral therapy, Andhra Pradesh, India, 2008–2011

BACKGROUND The national antiretroviral therapy (ART) initiative in India began in 2004. In order to better inform the national program, we estimated the mean cumulative survival probability and loss to follow-up (LFU) rate among patients initiated on ART. METHODS We identified a cohort of people living with HIV (PLHIV) aged ≥15 years initiated on ART in two ART centres in Hyderabad city, Andhra Pradesh state, India between January 2008 and December 2008. The cohort was followed-up until 31 December 2011 and death and/or LFU were the primary endpoints. Death from any cause during the study period was considered to be the result of HIV infection. We used the Kaplan-Meier estimation method for survival probability and Cox proportional hazard model to identify the predictors. RESULTS Of the 1690 patients initiated on ART, 259 (15.3%) were transferred out during the study period. Mortality rate was 7.6/100 person-years. Male gender, low CD4 count, history of tuberculosis before initiation of ART, and weight <48 kg were the predictors of mortality. Patients who were LFU were more likely to be males, unemployed, widowed, and had weight below 48 kg. CONCLUSION Survival rates on ART were higher compared to other resource-limited settings. Delayed diagnosis and initiation of ART and co-infection with TB were important predictors for both mortality and retention in care.

Near Full-Length Genomic Characterization of a Novel CRF 01_AE/C Recombinant from Western India

HIV is known for its genetic variability across the globe. The HIV epidemic in India is primarily driven by subtype C, although sporadic circulating and unique recombinant forms are also reported from a few metropolitan cities in which genotyping facilities are available. Here we report a novel CRF01_AE/C recombinant from a multicenter study on the effectiveness of antiretroviral therapy (ART), 12 months after its initiation. Our subject is a 32-year-old heterosexual female, a native of Pune city in western India. Identification and analyses of recombination breakpoints using jpHMM@Gobics and SimPlot bootscanning revealed six recombination breakpoints, indicating insertion of the CRF01_AE genome at three points in the backbone of subtype C. Both subtype C and CRF01_AE are commonly seen in the population at risk of heterosexual HIV transmission, thereby providing an opportunity for cocirculation and recombination. The emergence of a novel recombinant of CRF01_AE/C is indicative of the increasing genetic diversity of the HIV epidemic in India.

Predictors of immunological failure and determinants of suboptimal CD4 testing among adults with HIV on first-line antiretroviral therapy in Andhra Pradesh, India, 2008–2011

BACKGROUND Failure of first-line antiretroviral therapy (ART) results in high morbidity and mortality. We identified the predictors of immunological failure and suboptimal CD4 testing among adult people living with HIV (PLHIV) initiated on first-line ART. METHODS The cohort of PLHIV aged ≥ 15 years initiated on first-line ART in Hyderabad city, Andhra Pradesh state, in 2008 was followed-up until 31 December 2011 or until death and/or lost to follow-up (LFU). We estimated cumulative incidence of immunological failure. We explored socio-demographic, clinical, pharmacological and immunological factors to identify the predictors of immunological failure and determinants of suboptimal CD4 testing (<2 tests/year). RESULTS Among the 1431 PLHIV, 275 (19.2%) died and 263 (18.4%) were LFU. Of the remaining 893 (62.3%) patients on follow-up, 193 (21.6%) experienced immunological failure; these patients were more likely to be males, illiterate, with a history of pulmonary TB while on ART and taking stavudine-based regimen. Incidence of suboptimal testing ranged between 41 and 60% over 4 years of follow-up. Suboptimal CD4 testing among PLHIV was associated with history of TB prior to initiation of ART and stage 3 and 4 of HIV disease at enrollment. CONCLUSIONS There was low immunological failure rate but high incidence of suboptimal CD4 testing. The ART centre staff needs to be more vigilant about 6-monthly CD4 testing for timely detection of immunological failure and appropriate case management.

The cost‐effectiveness and budgetary impact of a dolutegravir‐based regimen as first‐line treatment of HIV infection in India

Dolutegravir (DTG)‐based antiretroviral therapy (ART) is recommended for first‐line HIV treatment in the US and Europe. Efavirenz (EFV)‐based regimens remain the standard of care (SOC) in India. We examined the clinical and economic impact of DTG‐based first‐line ART in the setting of Indias recent guidelines change to treating all patients with HIV infection regardless of CD4 count.

Delivery of antiretroviral treatment services in India: Estimated costs incurred under the National AIDS Control Programme

Competing domestic health priorities and shrinking financial support from external agencies necessitates that India’s National AIDS Control Programme (NACP) brings in cost efficiencies to sustain the programme. In addition, current plans to expand the criteria for eligibility for antiretroviral therapy (ART) in India will have significant financial implications in the near future. ART centres in India provide comprehensive services to people living with HIV (PLHIV): those fulfilling national eligibility criteria and receiving ART and those on pre-ART care, i.e. not on ART. ART centres are financially supported (i) directly by the NACP; and (ii) indirectly by general health systems. This study was conducted to determine (i) the cost incurred per patient per year of pre-ART and ART services at ART centres; and (ii) the proportion of this cost incurred by the NACP and by general health systems. The study used national data from April 2013 to March 2014, on ART costs and non-ART costs (human resources, laboratory tests, training, prophylaxis and management of opportunistic infections, hospitalization, operational, and programme management). Data were extracted from procurement records and reports, statements of expenditure at national and state level, records and reports from ART centres, databases of the National AIDS Control Organisation, and reports on use of antiretroviral drugs. The analysis estimates the cost for ART services as US

Assessment of quality of antiretroviral therapy services in India 2014-2015.

133.89 (?8032) per patient per year, of which 66% (US

Use of first line antiretroviral therapy from a free ART programme clinic in Pune, India - A preliminary report

88.66, ?5320) is for antiretroviral drugs and 34% (US

GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India

45.23, ?2712) is for non-ART recurrent expenditure, while the cost for pre-ART care is US

Survival outcomes for first-line antiretroviral therapy in India’s ART program

33.05 (?1983) per patient per year. The low costs incurred for patients in ART and pre-ART care services can be attributed mainly to the low costs of generic drugs. However, further integration with general health systems may facilitate additional cost saving, such as in human resources.