Outcomes of antiretroviral therapy in a northern Indian urban clinic

222 Bull World Health Organ 2010;88:222–226 | doi:10.2471/BLT.09.068759 Introduction The number of people infected with the human immuno- deficiency virus (HIV) worldwide was estimated to be 33.2 million at the end of 2007.1 The introduction of antiretro- viral therapy (ART) has significantly reduced morbidity and mortality in HIV-infected patients in various developed and developing countries.2–5 However, the outcome of ART in India’s national ART programme has not been reported. Background India is a developing nation with approximately 2.4 million people living with HIV and a national prevalence of HIV infection in adults of 0.36%.1 Until 2004, ART was avail- able only to a select subset of patients through the private sector; most of the HIV-infected population was unable to afford ART. India’s national ART programme was launched on 1 April 2004 under the National AIDS Control Organisa- tion (NACO), as an initiative of the Ministry of Health and Family Welfare of the Government of India. The programme was launched in eight institutions in six states with a high prevalence of HIV infection, and in the National Capital Region of Delhi. By December 2008, 197 ART centres were Outcomes of antiretroviral therapy in a northern Indian urban clinic Surendra K Sharma,a Sahajal Dhooria,a KT Prasad,a Ninoo George,a Sanjay Ranjan,a Deepak Gupta,a Vishnubhatla Sreenivas,b Tamilarasu Kadhiravan,c Sunita Miglani,a Sanjeev Sinha,a Naveet Wig,a Ashutosh Biswasa & Madhu Vajpayeed Problem Antiretroviral therapy (ART) programmes have been successful in several countries. However, whether they would succeed as part of a national programme in a resource-constrained setting such as India is not clear. The outcomes and specific problems encountered in such a setting have not been adequately studied. Approach We assessed the efficacy and functioning of India’s national ART programme in a tertiary care centre in northern India. All ART-naive patients started on ART between May 2005 and October 2006 were included in the study and were followed until 31 April 2008. Periodic clinical and laboratory evaluations were carried out in accordance with national guidelines. Changes in CD4+ lymphocyte count, body weight and body mass index were assessed at follow-up, and the operational problems analysed. Local setting The setting was a tertiary care centre in northern India with a mixed population of patients, mostly of low socioeconomic status. The centre is reasonably well resourced but faces constraints in health-care delivery, such as lack of adequate human resources and a high patient load. Relevant changes The response to ART in the cohort studied was comparable to that reported from other countries. However, the programme had a high attrition rate, possibly due to patient-related factors and operational constraints. Lessons learnt A high rate of attrition can affect the overall efficacy and functioning of an ART programme. Addressing the issues causing attrition might improve patient outcomes in India and in other resource-constrained countries. Une traduction en français de ce résumé figure à la fin de l’article. Al final del artículo se facilita una traducción al español. .ةلاقلما هذهل لماكلا صنلا ةياهن في ةصلاخلا هذهل ةيبرعلا ةمجترلا a Department of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India. b Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India. c Department of Medicine, Jawaharlal Institute of Post-Graduate Medical Education and Research, Puducherry, India. d Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India. Correspondence to Surendra K Sharma (e-mail: sksharma@aiims.ac.in). (Submitted: 17 June 2009 – Revised version received: 26 October 2009 – Accepted: 18 November 2009 ) functioning in 31 states and union territories and more than 193 000 patients were accessing free ART through these centres.6 Setting To ascertain the functioning and efficacy of the national ART programme, we assessed an ART centre that was opened at the All India Institute of Medical Sciences (AIIMS) Hospital, New Delhi, in May 2005. The AIIMS Hospital provides tertiary care to the popu- lation of Delhi and its neighbouring states, and most of its patients come from the lower socioeconomic strata. Patients with HIV infection tend to present in advanced stages of acquired immunodeficiency syndrome (AIDS) and are usu- ally referred to the hospital’s ART centre, which is staffed by a nodal officer, two physicians, a laboratory technician, a pharmacist, a nurse (who also acts as an AIDS educator), an ART counsellor, a data manager and a community health worker. The centre receives financial and logistic support from NACO through the Delhi State AIDS Control Society. This paper reports the outcomes of ART delivered from the clinic at the AIIMS Hospital and highlights some of the problems encountered in implementing ART. 223Bull World Health Organ 2010;88:222–226 | doi:10.2471/BLT.09.068759 Special theme – Communicable diseases in south-east Asia Antiretroviral therapy in a northern Indian clinicSurendra K Sharma et al. Methods To evaluate the effectiveness of the na- tional ART programme at the AIIMS Hospital, we undertook a prospective observational study involving ART- naive patients who were started on ART between May 2005 and October 2006. ART was offered to these patients in ac- cordance with NACO guidelines.7 The regimen consisted of two nucleoside reverse transcriptase inhibitors and one non-nucleoside reverse transcriptase inhibitor. The available drugs included efavirenz, lamivudine, nevirapine and zidovudine. The medications were dis- Table 1. Baseline characteristics of patients in a study of antiretroviral therapy outcomes in a tertiary care centre in northern India, 2005–2006 Characteristic Value Characteristic Value No. % No. % Total study population (n = 631) Occupation Malesa 502 80 Unemployed 218 34 Females 129 20 Unskilled worker 131 21 Age (years) Semi-skilled worker 104 17 15–20 8 1 Skilled worker 52 8 21–30 187 30 Clerk/shop owner/farm owner 93 15 31–40 297 47 Semiprofessional 14 2 41–50 99 16 Professional 19 3 > 50 40 6 Mode of transmission Malnourishedb 219 44 Blood transfusion 37 6 Education Heterosexual 542 86 Illiterate 113 18 Homosexual 5 1 Primary school 132 21 Professional needlestick 1 0.2 Middle school 87 14 Surgical 2 0.3 High school 120 19 Unknown 27 4 Intermediate schoolc 78 12 Unsafe injection 12 2 Bachelor’s degree 78 12 WHO clinical stagee Professional/post-graduate degree 23 4 1 84 13 Monthly income (Indian rupees)d 2 33 5 < 40 4 1 3 320 51 40–119 9 1 4 194 31 120–199 17 3 Anaemiaf 200–299 52 8 Male 296 77 300–399 97 15 Female 91 82 400–799 224 36 TB at the start of ART 177 28 ≥ 800 228 36 Initial ART regimen Smoker 63 10 Stavudine + lamivudine + nevirapine 312 49 Alcohol consumer 22 4 Stavudine + lamivudine + efavirenz 99 16 Zidovudine + lamivudine + nevirapine 153 24 Zidovudine + lamivudine + efavirenz 67 11 ART, antiretroviral therapy; TB, tuberculosis; WHO, World Health Organization. a The national data show a male to female ratio among the HIV-infected population of 61:39.9 b Malnutrition was defined by a body mass index (BMI) (kg/m²) < 18.5. c Intermediate school refers to the two years of education after high school in the 10 + 2 pattern of school education. d One United States dollar was equivalent to about 47 Indian rupees in May 2009. e Stages 3 and 4 are advanced stages of HIV infection. f For males, blood haemoglobin < 13 g/dl; for females, < 12 g/dl. pensed directly to the patients or their authorized representatives. Patients were seen 2 weeks after the start of ART and thereafter on a monthly basis. During each visit, pa- tients were evaluated for drug toxicity, clinical improvement and opportunis- tic infections. Adherence was assessed during each visit by pill count, and, through counselling, patients were motivated to adhere to therapy. Patients who failed to turn up within a week of the scheduled visit were contacted by telephone. The CD4+ lymphocyte (CD4) count (cells/µl) was estimated at baseline and at 6-month intervals during follow-up. Prophylaxis and treatment of opportunistic infections were in accordance with NACO guide- lines. Anti-tuberculosis treatment was administered according to the Revised National Tuberculosis Control Pro- gramme guidelines.8 Results Between 1 May 2005 and 31 October 2006, 1325 patients were enrolled in the ART clinic. Of these patients, 631 treatment-naive adolescents and adults were eligible for the study. Base- line characteristics for those enrolled 224 Bull World Health Organ 2010;88:222–226 | doi:10.2471/BLT.09.068759 Special theme – Communicable diseases in south-east Asia Antiretroviral therapy in a northern Indian clinic Surendra K Sharma et al. in the study are provided in Table 1. Patients had a mean age of 36 years (standard deviation, SD: 8.69); a mean weight of 54 kg in males (SD: ±10.03) and of 44 kg in females (SD: ±8.68); a mean body mass index of 19.25 kg/ m² (SD: ±3.19); a mean haemoglobin of 11 g/dl (SD: ±2.38) and a median CD4 count of 110 (interquartile range: 59–159). All patients were followed until 31 April 2008; the median follow-up period was 21 months (range: 0–36 months). At the end of 36 months, 344 of the 631 patients (55%) were still being followed; 139 (22%) had been lost to follow-up, 77 (12%) had died and 71 (11%) had been transferred to other NACO-sponsored ART centres. Among those lost to follow-up, 60% were lost during the first 3 months and 84% by one year. There was a consistent increase in the median CD4 count over the study period (Fig. 1). The CD4 count at 6 months was greater than the baseline value in 421 of 440 patients (96%). In total, 61% of patients gained weight, from a median of 50 kg at baseline to 57.5 kg at 36 months. Similarly, body mass index increased from a median of 19.2 at baseline to 21.6 at 36 months. Survival analysis showed that 90% of the patients were alive at 6 months, 87% at 12 months and 84% at the end of 36 months. The overall mortal- ity rate was 8.5 per 100 patient–years and the post-90-day mortality rate was 5.8 per 100 patient–years. There was no significant difference in survival between patients with and without tu- berculosis (TB) (P = 0.623). A total of 192 patients (30%) required a change in their first-line medication. The most common reasons for this were initia- tion of anti-tuberculosis treatment (127 patients, 66%), adverse drug reactions (57 patients, 30%) and treatment fail- ure (8 patients, 4%). Discussion This study confirms that ART deliv- ery through a national programme in a resource-constrained setting can be effective. Most of the patients in the study showed a good clinical response to therapy, as indicated by significant weight gain and improvement in CD4 count. Around 82% of them had reached an advanced stage of illness (World Health Organization stage 3 or 4) at presentation, highlighting Fig. 1. Changes in median CD4+ lymphocyte count over 36 months in a study of antiretroviral therapy outcomes in a tertiary care centre in northern India, 2005–2006 0 CD 4+ ly m ph oc yt e co un t ( ce lls / l) 1500 Months from the start of antiretroviral treatment 0 95% CI 1000 500 6 12 18 24 30 36 the need for early diagnosis and treat- ment. The overall mortality rate in our study was higher than reported from other developed and developing coun- tries.10,11 Nevertheless, the post-90-day mortality rate was similar to the rate observed in another study.10 In line with previous studies, we found no significant association be- tween TB and mortality.5,12 In a study from Uganda, TB was associated with increased mortality only in HIV pa- tients with a CD4 count > 200 cells/ µl.12 It may be that TB facilitates HIV viral replication to a greater extent in the earlier stages of HIV infection than during advanced illness, when viral replication is already at its peak. In our study, patients with TB had a mean baseline CD4 count of 109 cells/µl, in- dicative of advanced disease; this may explain why TB was not significantly associated with mortality. In addition, treatment for TB was rigorously super- vised under the directly observed treat- ment strategy of the Revised National Tuberculosis Control Programme. A major limitation of this study is that the causes of mortality were un- known; most deaths occurred at home and their exact causes could not be ascertained by telephone. Another limi- tation was the high number of patients lost to follow-up. This group requires special attention because it tends to have higher mortality, as shown in a recent review.13 The high loss to follow- up may have been linked to poverty (all patients had a monthly income of < 17 United States dollars), unemployment (34%) and a poor literacy rate (53% pa- tients had not completed high school), coupled with poor awareness of AIDS and social stigma about the disease, as revealed by a similar study from India.14 Other deterrents to patient follow-up may have included initial improve- ment in health, adverse drug reactions and difficulties with transport (most patients came from distant areas with poor transport facilities). Currently, the only mechanism in the programme for retrieving patients lost to a treatment facility is to telephone them – an ap- proach that is inadequate because of poor patient response or incorrect or outdated telephone numbers. Loss to follow-up during transfer of patients to other health-care facilities was another weak area in patient care. The setting we studied had reason- able resources and was favourably lo- cated in an urban area. Nevertheless, we encountered difficulties such as limited human resources for handling the high patient load; lack of adequate space in the clinic for counselling, examina- tion and investigations; difficulty in 225Bull World Health Organ 2010;88:222–226 | doi:10.2471/BLT.09.068759 Special theme – Communicable diseases in south-east Asia Antiretroviral therapy in a northern Indian clinicSurendra K Sharma et al. Résumé Résultats du traitement antirétroviral dans un dispensaire urbain du Nord de l'Inde Problématique Les programmes de traitement antirétroviral (TARV) ont donné des résultats satisfaisants dans plusieurs pays. Néanmoins, il n'est pas certain qu'un tel programme réussisse dans le cadre du programme national d'un pays aux ressources limitées comme l'Inde. Les résultats et les problèmes spécifiques rencontrés dans ce type de contexte n'ont pas encore été suffisamment étudiés. Démarche Nous avons évalué l'efficacité et le fonctionnement du Programme TARV national indien dans le cadre d'un centre de soins tertiaires du Nord de l'Inde. Tous les patients auparavant naïfs de traitement ARV et ayant débuté ce traitement entre mai 2005 et octobre 2006 ont été inclus dans l'étude et ont été suivis jusqu'au 31 avril 2008. Des évaluations cliniques et analytiques périodiques ont été effectuées conformément aux directives nationales. Les évolutions de la numération des lymphocytes CD4+, du poids corporel et de l'indice de masse corporelle ont été évaluées dans le cadre du suivi et les difficultés opérationnelles ont été analysées. Contexte local L'étude s'est déroulée dans un centre de soins tertiaires du Nord de l'Inde, sur une population mixte de patients, dont la plupart présentaient un faible statut socioéconomique. Ce centre était raisonnablement bien doté en ressources, mais devait faire face à des contraintes dans la délivrance des soins, telles que le manque de personnel approprié et la forte affluence des patients. Modifications pertinentes La réponse au TARV dans la cohorte étudiée était comparable à celles rapportés dans d'autres pays. Néanmoins, le programme présentait un taux d'attrition élevé, pouvant être dû à des facteurs liés aux patients et aux contraintes de fonctionnement du centre. Enseignements tirés Un taux élevé d'attrition peut nuire à l'efficacité globale et au fonctionnement du programme TARV. Remédier aux problèmes à l'origine de cette attrition pourrait améliorer les résultats thérapeutiques pour les patients en Inde et dans d'autres pays à ressources limitées. maintaining confidentiality due to lack of separate rooms; and lack of availabil- ity of second-line ART. Potential solutions to the issues raised here include better education and motivation of patients, early re- ferral for diagnosis and treatment, de- centralization of the ART programme, institution of home visits, an increase in human resources and provision of adequate space in clinics, and greater availability of second-line ART for non-responders. Creating social sup- port groups and a vibrant patient education programme, not only in the hospital but also in the communi- ties near patients’ residences, would help dispel the misconceptions and stigma associated with HIV infection. Decentralizing the programme and providing travel reimbursement would undoubtedly increase attendance, and strengthening communication among local ART centres would enhance continuity in patient care. And while greater involvement on the part of nongovernmental organizations in HIV care and treatment would obviously be beneficial, it requires good audit and accountability systems to prevent the misuse of resources. Box 1. Summary of main lessons learnt • Treatment outcomes observed in our study are comparable to those reported in previous studies in other settings and show that antiretroviral therapy (ART) delivery through a national programme in a resource-constrained setting can be effective. • A high attrition rate can affect the overall efficacy and functioning of an ART programme. • Addressing the issues causing attrition may improve patient outcomes in India and in countries with similar resource-constrained settings. We feel that better treatment out- comes would be achieved by strength- ening human resources in the centre, improving the infrastructure, diverting stable patients to peripheral ART cen- tres and providing second-line ART for non-responders. Prioritizing sick HIV- infected patients for hospitalization may also lead to improved outcomes. Box 1 summarizes the lessons learnt in this study. Conclusion The treatment outcomes observed in our study are comparable to those re- ported in previous studies. Although the results are based on a limited num- ber of patients and arriving at definitive conclusions may be premature, the results draw attention to certain im- portant constraints that an ART centre would face in the Indian subcontinent. Such sociocultural and operational con- straints need to be properly addressed, besides provision of free ART, to derive the complete benefit of ART through such a national programme. ■ Acknowledgements We thank the NACO and the Delhi State AIDS Control Society for their work in establishing the ART centre at the AIIMS Hospital, New Delhi, and for providing financial and logistic support. The authors also thank resi- dents, consultants, and other support and administration staff of the AIIMS Hospital. Competing interests: None declared. Resumen Resultados de la terapia antirretroviral en un dispensario urbano en el norte de la India Problema Los programas de tratamiento antirretroviral (TAR) han cosechado buenos resultados en varios países. Sin embargo, no está claro si se desarrollarían también de forma satisfactoria como componente de un programa nacional en un entorno con recursos limitados como la India. Los resultados y los problemas específicos observados en esas circunstancias no han sido estudiados adecuadamente. Enfoque Se evaluó la eficacia y el funcionamiento del programa 226 Bull World Health Organ 2010;88:222–226 | doi:10.2471/BLT.09.068759 Special theme – Communicable diseases in south-east Asia Antiretroviral therapy in a northern Indian clinic Surendra K Sharma et al. صخلم دنهلا ليماش في ةيضرح ةدايع في ةيرقهقلا تاسويرفلا تاداضبم ةجلاعلما جئاتن ةدع في ةيرقهقلا تاسويرفلا تاداضبم ةجلاعلما جمارب تحجن :ةلكشلما دراولما ةدودحلما قطانلما في ينطو جمانرب نم ءزجك اهحاجن نأ لاإ ،نادلب نكيم يتلا ةصاخلا لكاشلماو جئاتنلا سردُت لمو ،حضاو يرغ لازام دنهلا لثم .ةيفاك ةسارد قطانلما هذه لثم في اهتفداصم ةجلاعملل يدنهلا ينطولا جمانبرلا ةفيظوو ةعاجن نوثحابلا ميق :بولسلأا ددجلا ضىرلما عيمج ةساردلا في جردأ دقو .ةيرقهقلا تاسويرفلا تاداضبم ىتح 2005 ويام/رايأ نم ًاءدب ةيرقهقلا تاسويرفلا تاداضبم ينجلاعلما ليربأ/ناسين 31 ىتح مهتعباتم ترمتساو ،2006 ربوتكأ/لولأا نيشرت ةيداشرلإا لئلادلل ًاقفو مهل يرود يبرتخمو يريسر مييقت يرجأو .2008 ،مسجلا نزوو ،CD4+ تايوافمللا ددع في تايرغتلا تسيقو .ةينطولا .ةيناديلما لكاشلما ليلحت متو ،ةعباتلما ءانثأ مسجلا ةلتك بسنمو دجوي ثيح دنهلا ليماش في ةيثلاثلا ةياعرلل ًازكرم عقولما ناك :ةيلحلما ةلاحلا ناكو .ةضفخنم ةيداصتقلااو ةيعماتجلاا مهتلاح مهبلغأ ،ضىرلما نم طيلخ ةلق لثم ،ةيحصلا ةياعرلا ءاتيإ في ًادويق هجاوي ناك هنكلو ،دراولما ديج زكرلما .ضىرملل مخضلا ءبعلاو ،ةيشربلا دراولما ةيرقهقلا تاسويرفلا تاداضبم ةجلاعلما ةباجتسا ناك :ةلصلا تاذ تايرغتلا نأ لاإ .ىرخلأا نادلبلا تاغلاب عم ةهباشتم مهتسارد ترج نيذلا بارتلأا في ضىرلماب ةلص اهل لماوع لىإ كلذ عجري دقو ،لاع صقانت لدعم دهش جمانبرلا .ةيناديلما دويقلل ةجيتن وأ ةعاجن لمجم لىع رثؤي نأ نكيم صقانتلل لياعلا لدعلما :ةدافتسلما سوردلا ءلايإ يدؤيسو .ةيرقهقلا تاسويرفلا تاداضبم ةجلاعلما جمانرب ةفيظوو فيو دنهلا في ضىرلما جئاتن ينسحت لىإ صقانتلا اذهل ةيدؤلما لكاشلماب مماتهلاا .ىرخلأا نادلبلا في دراولما ةدودحلما عقاولما References 1. 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Se incluyó en el estudio a todos los pacientes sin tratamiento antirretrovírico previo que empezaron a tomar antirretrovirales entre mayo de 2005 y octubre de 2006, los cuales fueron sometidos a seguimiento hasta el 31 de abril de 2008. De forma periódica se llevaron a cabo evaluaciones clínicas y de laboratorio de conformidad con las directrices nacionales. En cada sesión de seguimiento se analizaron la variación del recuento de linfocitos CD4+, el peso corporal y el índice de masa corporal, así como los problemas operacionales surgidos. Contexto local Se trabajó en un centro de atención terciaria del norte de la India con una población diversa de pacientes, la mayoría de nivel socioeconómico bajo. El centro cuenta con unos recursos razonables, pero ve tensionada su capacidad asistencial debido a la falta de recursos humanos apropiados y al alto volumen de pacientes. Cambios destacables La respuesta a la TAR en la cohorte estudiada fue comparable a la descrita en otros países. Sin embargo, el programa presentó una tasa de deserción elevada, posiblemente debido a factores relacionados con el paciente y a limitaciones operacionales. Enseñanzas extraídas Una alta tasa de deserción puede menoscabar la eficacia y el funcionamiento globales de los programas de ART. Encarando los problemas causantes de esas deserciones se podría conseguir que los pacientes evolucionaran mejor en la India y en otros países con recursos limitados.