• Adherence to antiretroviral therapy in patients enrolled in a comprehensive care program in Cambodia: a 24-month follow-up assessment

      Spire, Bruno; Carrieri, Patrizia; Sopha, Pal; Protopopescu, Camelia; Prak, Narom; Quillet, Catherine; Ngeth, Chanchhaya; Ferradini, Laurent; Delfraissy, Jean-François; Laureillard, Didier; Inserm U912, Economic and Social Sciences, Health Systems and Societies, Marseille, France; Infectious Disease Department, Khmero-Sovietic Friendship Hospital, Phnom Penh, Cambodia; Médecins Sans Frontières, Paris, France; Epicentre, Paris, France; Clinical Immunology Department, Bicêtre Hospital, Kremlin Bicêtre, France; Immunological Department, Georges Pompidou, European Hospital, Paris France (2008-05)
      BACKGROUND: The long-term maintenance of antiretroviral therapy (ART) remains an important issue, especially in limited-resource settings where additional barriers exist. A cross-sectional study was performed 24 months after ART initiation for patients treated in Cambodia in order to estimate the prevalence and identify determinants of non-adherence. METHODS: Adults receiving ART for 24 +/- 2 months were considered eligible for the study. Self-reported non-adherence was defined according to an algorithm based on six items. The questionnaire also assessed ART-related side effects and HIV disclosure. HIV-1 RNA plasma viral load was measured using real-time PCR. Multivariate rare events logistic regression analysis was used to identify independent factors associated with non-adherence. RESULTS: A total of 346 patients participated in the study. At 24 months, 95% of patients were adherent, 80% had HIV RNA <40 copies/ml and 75% had CD4+ T-cell counts >200 cells/mm3. Virological success was significantly higher in adherent patients than in non-adherent patients (81% versus 56%, P=0.021). Living in a rural area, limited HIV disclosure and perceived lipodystrophy were independently associated with non-adherence. CONCLUSIONS: At 24 months, adherence to ART was high and explained positive virological outcomes. In order to maintain adherence and long-term virological benefits, special attention should be given to patients living in rural areas, those with lipodystrophy-related symptoms and others who express difficulties disclosing their condition to close family members.
    • Adults receiving HIV care before the start of antiretroviral therapy in sub-Saharan Africa: patient outcomes and associated risk factors

      Bastard, Mathieu; Nicolay, Nathalie; Szumilin, Elisabeth; Balkan, Suna; Poulet, Elisabeth; Pujades-Rodriguez, Mar (Lippincott Williams & Wilkins, 2013-12-15)
      Gaining understanding of the period before antiretroviral therapy (ART) is needed to improve treatment outcomes and to reduce HIV transmission. This study describes the cascade of enrollment in HIV care, pre-ART follow-up, and predictors of mortality and lost to follow-up (LTFU) before ART initiation.
    • Association between older age and adverse outcomes on antiretroviral therapy: a cohort analysis of programme data from nine countries.

      Greig, Jane; Casas, Esther C; O'Brien, Daniel P; Mills, Edward J; Ford, Nathan; Médecins Sans Frontières, London, UK. jane.greig@london.msf.org (2012-07-31)
      Recent studies have highlighted the increased risk of adverse outcomes among older patients on antiretroviral therapy (ART). We report on the associations between older age and adverse outcomes in HIV/AIDS antiretroviral programmes across 17 programmes in sub-Saharan Africa.
    • Community support is associated with better antiretroviral treatment outcomes in a resource-limited rural district in Malawi.

      Zachariah, R; Teck, R; Buhendwa, L; Fitzgerald, M; Labana, S; Chinji, C; Humblet, P; Harries, A D; Médecins Sans Frontières, Medical Department (Operational Research), Brussels Operational Center, 68 Rue de Gasperich, L-1617, Luxembourg, Belgium. zachariah@internet.lu (Elsevier, 2007-01)
      A study was carried in a rural district in Malawi among HIV-positive individuals placed on antiretroviral treatment (ART) in order to verify if community support influences ART outcomes. Standardized ART outcomes in areas of the district with and without community support were compared. Between April 2003 (when ART was started) and December 2004 a total of 1634 individuals had been placed on ART. Eight hundred and ninety-five (55%) individuals were offered community support, while 739 received no such support. For all patients placed on ART with and without community support, those who were alive and continuing ART were 96 and 76%, respectively (P<0.001); death was 3.5 and 15.5% (P<0.001); loss to follow-up was 0.1 and 5.2% (P<0.001); and stopped ART was 0.8 and 3.3% (P<0.001). The relative risks (with 95% CI) for alive and on ART [1.26 (1.21-1.32)], death [0.22 (0.15-0.33)], loss to follow-up [0.02 (0-0.12)] and stopped ART [0.23 (0.08-0.54)] were all significantly better in those offered community support (P<0.001). Community support is associated with a considerably lower death rate and better overall ART outcomes. The community might be an unrecognized and largely 'unexploited resource' that could play an important contributory role in countries desperately trying to scale up ART with limited resources.
    • Cytomegalovirus retinitis: the neglected disease of the AIDS pandemic.

      Heiden, D; Ford, N; Wilson, D; Rodriguez, W; Margolis, T; Janssens, B; Bedelu, M; Tun, N; Goemaere, E; Saranchuk, P; Sabapathy, K; Smithuis, F; Luyirika, E; Drew, W L; Department of Ophthalmology and Pacific Vision Foundation, California Pacific Medical Center, San Francisco, California, United States of America. dheidenpea@yahoo.com (PLoS, 2007-12)
    • Development of dual-class antiretroviral drug resistance in a child coinfected with HIV and tuberculosis: a case report from KwaZulu-Natal, South Africa.

      Murphy, R A; France, H; Sunpath, H; Gordon, M L; Marconi, V; Kuritzkes, D R; McIntosh, K; Massachusetts General Hospital, and Brigham and Women's Hospital, Boston, MA, USA. richard.murphy@newyork.msf.org (Published by Oxford University Press, 2009-02)
      The treatment of concurrent HIV and tuberculosis (TB) in children <3 years of age has not been well-studied and is complicated by potential drug-drug interactions. The recommended antiretroviral therapy (ART) in coinfected children in South Africa consists of full-strength ritonavir, lamivudine and stavudine. We report on a child initiated on this regimen, during concurrent TB treatment, who promptly developed an adverse reaction, virologic failure and dual-class antiretroviral drug resistance, compromising subsequent salvage ART.
    • Effectiveness of a PMTCT programme in rural Western Kenya.

      Azcoaga-Lorenzo, A; Ferreyra, C; Alvarez, A; Palma, P P; Velilla, E; del Amo, J; Medecins Sans Frontieres-Spain/Operational Centre Barcelona-Athens, Barcelona, Spain. azcoaga@yahoo.es (Taylor and Francis, 2011-03)
      We assess the coverage of a Prevention of Mother-to-child Transmission (PMTCT) programme in Busia (Kenya) from 1 January 2006 to 31 December 2008 and estimate the risk of transmission of HIV. We also estimate the odds of HIV transmission according to pharmacological intervention received. Programme coverage was estimated as the proportion of mother-baby pairs receiving any antiretroviral (ARV) regimen among all HIV-positive women attending services. We estimated the mother-to-child transmission (MTCT) rate and their 95% confidence interval (95%CI) using the direct method of calculation (intermediate estimate). A case-control study was established among all children born to HIV-positive mothers with information on outcome (HIV status of the babies) and exposure (data on pharmacological intervention). Cases were all HIV-positive children and controls were the HIV-negative ones. Exposure was defined as: (1) complete protocol: ARV prescribed according World Health Organisation recommendations; (2) partial protocol: does not meet criteria for complete protocol; and (3) no intervention: ARVs were not prescribed to both mother and child. Babies were tested using DNA Polymerase Chain Reaction at six weeks of life and six weeks after breastfeeding ceased. In the study period, 22,566 women accepted testing, 1668 were HIV positive (7.4%; 95%CI 7.05-7.73); 1036 (62%) registered in the programme and 632 were lost. Programme coverage was 40.4% (95%CI 37.9-42.7). Out of the 767 newborns, 28 (3.6%) died, 148 (19.3%) defaulted, 282 (36.7%) were administratively censored and 309 (40.2%) babies completed the follow-up as per protocol; 49 were HIV positive and MTCT risk was 15.86% (95%CI 11.6-20.1). The odds of having an HIV-positive baby was 4.6 times higher among pairs receiving a partial protocol compared to those receiving a complete protocol and 43 times higher among those receiving no intervention. Our data show a good level of enrolment but low global coverage rate. It demonstrates that ARV regimens can be implemented in low resource rural settings with marked decreases of MTCT. Increasing the coverage of PMTCT programmes remains the main challenge.
    • Effectiveness of the first district-wide programme for the prevention of mother-to-child transmission of HIV in South Africa.

      Coetzee, D; Hilderbrand, K; Boulle, A; Draper, B; Abdullah, F; Goemaere, E; Infectious Disease Epidemiology Unit, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa. dcoetzee@phfm.uct.ac.za (WHO, 2005-07)
      OBJECTIVE: The aim of this study was to estimate the field efficacy of the first routine programme for the prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV) initiated in South Africa, in the subdistrict of Khayelitsha. METHODS: A consecutive sample of 658 mother-infant pairs, identified from the PMTCT register from 1 March to 30 November 2003, were identified for enrolment in this study. Details of the regimen received were established and HIV status of the infants at between 6 and 10 weeks of age was determined by qualitative DNA polymerase chain reaction. Zidovudine (AZT) was provided antenatally from week 34 of gestation and during labour. Infant formula milk was-offered to mothers who chose not to breastfeed. The protocol was amended in July 2003 such that women who had received < 2 weeks of treatment with AZT were given a single dose of nevirapine (NVP) at the onset of labour, and the infant received a weight-adjusted dose of NVP within 72 h of delivery. RESULTS: Of the 535 mother-infant pairs (81%) eventually included in the study, 410 (77%) received an effective PMTCT intervention according to the protocol. The rate of transmission of HIV from mother to child was 8.8% (95% confidence interval (CI), 6.2-10.9). A maternal age of > 25 years was the only significant independent risk factor for transmission (odds ratio, 2.12; 95% CI, 1.14-4.07). CONCLUSION: The results of this study demonstrate the feasibility and effectiveness of a large-scale PMTCT programme in an urban public-sector setting.
    • Evaluation of a 5-year programme to prevent mother-to-child transmission of HIV infection in Northern Uganda

      Ahoua, Laurence; Ayikoru, Harriet; Gnauck, Katherine; Odaru, Grace; Odar, Emmanuel; Ondoa-Onama, Christine; Pinoges, Loretxu; Balkan, Suna; Olson, David; Pujades-Rodríguez, Mar; Epicentre, Paris, France; Medecins Sans Frontieres, Kampala, Uganda; Arua Regional District Hospital, Ministry of Health, Arua, Uganda; Medecins Sans Frontieres, Paris, France (2010-07-13)
      Prevention of mother-to-child transmission (PMTCT) is essential in HIV/AIDS control. We analysed 2000-05 data from mother-infant pairs in our PMTCT programme in rural Uganda, examining programme utilization and outcomes, HIV transmission rates and predictors of death or loss to follow-up (LFU). Out of 19,017 women, 1,037 (5.5%) attending antenatal care services tested HIV positive. Of these, 517 (50%) enrolled in the PMTCT programme and gave birth to 567 infants. Before tracing, 303 (53%) mother-infant pairs were LFU. Reasons for dropout were infant death and lack of understanding of importance of follow-up. Risk of death or LFU was higher among infants with no or incomplete intrapartum prophylaxis (OR = 1.90, 95% CI 1.07-3.36) and of weaning age <6 months (OR 2.55, 95% CI 1.42-4.58), and lower in infants with diagnosed acute illness (OR 0.30, 95% CI 0.16-0.55). Mother-to-child HIV cumulative transmission rate was 8.3%, and 15.5% when HIV-related deaths were considered. Improved tracking of HIV-exposed infants is needed in PMTCT programmes where access to early infant diagnosis is still limited.
    • Generic Fixed-Dose Combination Antiretroviral Treatment in Resource-Poor Settings: Multicentric Observational Cohort

      Calmy, A; Pinoges, L; Szumilin, E; Zachariah, R; Ford, N; Ferradini, L; MSF, Campaign for Access to Essential Medicines, 78 rue de Lausanne, 1205 Geneva, Switzerland. acalmy@stvincents.com.au (2006-05-12)
      BACKGROUND: The use fixed-dose combination (FDC) is a critical tool in improving HAART. Studies on the effectiveness of combined lamivudine, stavudine and nevirapine (3TC/d4T/NVP) are scarce. OBJECTIVE: To analyse 6861 patients in a large observational cohort from 21 Médecins Sans Frontieres (MSF) HIV/AIDS programmes taking 3TC/d4T/NVP, with subcohort analyses of patients at 12 and 18 months of treatment. METHODS: Survival was analysed using Kaplan-Meier method and factors associated with progression to death with Cox proportional hazard ratio. RESULTS: Median baseline CD4 cell count at initiating of FDC was 89 cells/microl [interquartile range (IQR), 33-158]. The median follow-up time was 4.1 months (IQR, 1.9-7.3). The incidence rate of death during follow-up was 14.2/100 person-years [95% confidence interval (CI), 13.8-14.5]. Estimates of survival (excluding those lost to follow-up) were 0.93 (95% CI, 92-94) at 6 months (n = 2,231) and 0.90 (95% CI, 89-91) at 12 months (n = 472). Using a Cox model, the following factors were associated with death: male gender, symptomatic infection, body mass index < 18 kg/m and CD4 cell count 15-50 cells/microl or < 15 cells/microl. Subcohort analysis of 655 patients after 1 year of follow-up (M12 FDC cohort) revealed that 77% remained on HAART, 91% of these still on the FDC regimen; 5% discontinued the FDC because of drug intolerance. At 18 months, 77% of the patients remained on HAART. CONCLUSIONS: Positive outcomes for d4T/3TC/NVP are reported for up to 18 months in terms of efficacy and safety.
    • Highly Active Antiretroviral Therapy in Resource-Poor Settings: The Experience of Médecins Sans Frontières.

      Tassie, J M; Szumilin, E; Calmy, A; Goemaere, E; Epicentre, Paris, France. (2003-09-05)
      We describe the short-term results of highly active antiretroviral therapy (HAART) in seven projects in low and middle income countries. A total of 743 adults were included, and clinical, immunological and virological responses were analysed. At 6 months, outcomes were similar to those observed in western countries, and the probability of remaining on treatment was 94%. The challenge now is to extend access to HAART to the millions in urgent need.
    • HIV prevention, care, and treatment in two prisons in Thailand.

      Wilson, D; Ford, N; Ngammee, V; Chua, A; Kyaw, M K K; Médecins Sans Frontières, Bangkapi, Bangkok, Thailand. (Public Library of Science, 2007-06)
    • HIV Viral Load Monitoring in Resource-Limited Regions: Optional or Necessary?

      Calmy, A; Ford, N; Hirschel, B; Reynolds, S; Lynen, L; Goemaere, E; Garcia de la Vega, F; Perrin, L; Rodriguez, W; Medecins sans Frontieres, Access to Medicines Campaign, Geneva, 1211, Switzerland. acalmy@gmail.com (Published by: Infectious Diseases Society of America, 2007-01-01)
      Although it is a standard practice in high-income countries, determination of the human immunodeficiency virus (HIV) load is not recommended in developing countries because of the costs and technical constraints. As more and more countries establish capacity to provide second-line therapy, and as costs and technological constraints associated with viral load testing decrease, the question of whether determination of the viral load is necessary deserves attention. Viral load testing could increase in importance as a guide for clinical decisions on when to switch to second-line treatment and on how to optimize the duration of the first-line treatment regimen. In addition, the viral load is a particularly useful tool for monitoring adherence to treatment, performing sentinel surveillance, and diagnosing HIV infection in children aged <18 months. Rather than considering viral load data to be an unaffordable luxury, efforts should be made to ensure that viral load testing becomes affordable, simple, and easy to use in resource-limited settings.
    • Immunovirological outcomes and resistance patterns at 4 years of antiretroviral therapy use in HIV-infected patients in Cambodia

      Pujades-Rodríguez, Mar; Schramm, Birgit; Som, Leakena; Nerrienet, Eric; Narom, Prak; Chanchhaya, Ngeth; Ferradini, Laurent; Balkan, Suna; Epicentre, Paris, France; Medecins Sans Frontieres, Phnom Penh, Cambodia; HIV⁄Hepatitis Laboratory, Pasteur Institute, Phnom Penh, Cambodia; Khmero-Sovietic Friendship Hospital, Phnom Penh, Cambodia; Medecins Sans Frontieres, Paris, France (2011-02-01)
      Objectives  To report immunovirological outcomes and resistance patterns in adults treated with triple combination antiretroviral therapy (cART) for 4 years in an HIV programme of Phnom Penh, Cambodia. Methods  It is a longitudinal study and cross-sectional evaluation of adults receiving cART for 4 years. CD4 cell counts and HIV-1 RNA were quantified, and resistance patterns were determined. Drug-related toxicity was assessed by clinicians and through laboratory testing. Results  After 4 years of cART start, the cumulative probability of retention in care was 0.80 and survival among patients not lost to follow-up was 0.85. A total of 349 patients (98% of eligible) participated in the cross-sectional evaluation. Ninety per cent were receiving first-line therapy, 29% stavudine- and 58% zidovudine-containing regimens (compared with 94% and 3% at cART initiation). Ninety-three per cent of patients were clinically asymptomatic, and severe lipodystrophy and dyslipidemia were diagnosed in 7.2% and 4.0%, respectively. Good treatment adherence was reported by 83% of patients. Median CD4 T-cell count was 410 cells/μl [IQR 290-511], and 90% of patients had >200 cells/μl. Only 15 (4%) patients had detectable HIV viral load (eight had <200 CD4 cells/μl), five had thymidine analogue mutations, and nine were resistant to two drug classes. In an intention-to-treat analysis, 26.1% (95% CI 22.0-30.5) of patients had failed first-line therapy. Conclusions  In this Cambodian cohort of adults who started cART at an advanced stage of HIV disease, we observed good clinical and immunovirological outcomes and self-reported treatment adherence at 4 years of therapy.
    • Implementing a tenofovir-based first-line regimen in rural Lesotho: clinical outcomes and toxicities after two years.

      Bygrave, Helen; Ford, Nathan; van Cutsem, Gilles; Hilderbrand, Katherine; Jouquet, Guillaume; Goemaere, Eric; Vlahakis, Nathalie; Triviño, Laura; Makakole, Lipontso; Kranzer, Katharina; Médecins Sans Frontières, Morija, Lesotho. helen.bygrave@joburg.msf.org (2011-03)
      The latest World Health Organization guidelines recommend replacing stavudine with tenofovir or zidovudine in first-line antiretroviral therapy in resource-limited settings. We report on outcomes and toxicities among patients on these different regimens in a routine treatment cohort in Lesotho.
    • Monitoring HIV Viral Load in Resource Limited Settings: Still a Matter of Debate?

      Arnedo, M; Alonso, E; Eisenberg, N; Ibáñez, L; Ferreyra, C; Jaén, A; Flevaud, L; Khamadi, S; Roddy, P; Gatell, JM; Dalmau, D (Public Library of Science, 2012-12-06)
      Consequences of lack of viral monitoring in predicting the effects of development of HIV drug resistance mutations during HAART in resource-limited settings (RLS) is still a matter of debate.
    • Monitoring the response to antiretroviral therapy in resource-poor settings: the Malawi model.

      Harries, A D; Gomani, P; Teck, R; de Teck, O; Bakali, E; Zachariah, R; Libamba, E; Mwansambo, A; Salaniponi, F; Mpazanje, R; National Tuberculosis Control Programme, Ministry of Health and Population, P.O. Box 30377, Lilongwe, Malawi. adharries@malawi.net (2004-12)
      With assistance from the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), Malawi is scaling-up the delivery of antiretroviral (ARV) therapy to HIV-positive eligible patients. The country has developed National ARV Treatment Guidelines, which emphasize a structured and standardized approach for all aspects of ARV delivery, including monitoring and evaluation. Using the successful DOTS model adapted by National TB Control Programmes throughout the world, Malawi has developed a system of quarterly ARV cohort and cumulative ARV quarterly analyses. Thyolo district, in the southern region of Malawi, has been using this system since April 2003. This paper describes the standardized ARV treatment regimens and the treatment outcomes used in Thyolo to assess the impact of treatment, the registration and monitoring systems and how the cohort analyses are carried out. Data are presented for case registration and treatment outcome for the first quarterly cohort (April to June) and the combined cohorts (April to June and July to September). Such quarterly analyses may be useful for districts and Ministries of Health in assessing ARV delivery, although the burden of work involved in calculating the numbers may become large once ARV delivery systems have been established for several years.
    • Offering Integrated Care for HIV/AIDS, Diabetes and Hypertension within Chronic Disease Clinics in Cambodia.

      Janssens, B; Van Damme, W; Raleigh, B; Gupta, J; Khem, S; Soy Ty, K; Vun, M; Ford, N; Zachariah, R; Médecins Sans Frontières, Phnom Penh, Cambodia. b.janssens@bigfoot.com (WHO, 2007-11)
      PROBLEM: In Cambodia, care for people with HIV/AIDS (prevalence 1.9%) is expanding, but care for people with type II diabetes (prevalence 5-10%), arterial hypertension and other treatable chronic diseases remains very limited. APPROACH: We describe the experience and outcomes of offering integrated care for HIV/AIDS, diabetes and hypertension within the setting of chronic disease clinics. LOCAL SETTING: Chronic disease clinics were set up in the provincial referral hospitals of Siem Reap and Takeo, 2 provincial capitals in Cambodia. RELEVANT CHANGES: At 24 months of care, 87.7% of all HIV/AIDS patients were alive and in active follow-up. For diabetes patients, this proportion was 71%. Of the HIV/AIDS patients, 9.3% had died and 3% were lost to follow-up, while for diabetes this included 3 (0.1%) deaths and 28.9% lost to follow-up. Of all diabetes patients who stayed more than 3 months in the cohort, 90% were still in follow-up at 24 months. LESSONS LEARNED: Over the first three years, the chronic disease clinics have demonstrated the feasibility of integrating care for HIV/AIDS with non-communicable chronic diseases in Cambodia. Adherence support strategies proved to be complementary, resulting in good outcomes. Services were well accepted by patients, and this has had a positive effect on HIV/AIDS-related stigma. This experience shows how care for HIV/AIDS patients can act as an impetus to tackle other common chronic diseases.
    • Outcomes after two years of providing antiretroviral treatment in Khayelitsha, South Africa.

      Coetzee, D; Hildebrand, K; Boulle, A; Maartens, G; Louis, F; Labatala, V; Reuter, H; Ntwana, N; Goemaere, E; Infectious Disease Epidemiology Unit, School of Public Health and Family Medicine, University of Cape Town, Anzio Road, Observatory 7925, South Africa. (2004-04-09)
      BACKGROUND: A community-based antiretroviral therapy (ART) programme was established in 2001 in a South African township to explore the operational issues involved in providing ART in the public sector in resource-limited settings and demonstrate the feasibility of such a service. METHODS: Data was analysed on a cohort of patients with symptomatic HIV disease and a CD4 lymphocyte count < 200 x 10 cells/l. The programme used standardized protocols (using generic medicines whenever possible), a team-approach to clinical care and a patient-centred approach to promote adherence. RESULTS: Two-hundred and eighty-seven adults naive to prior ART were followed for a median duration of 13.9 months. The median CD4 lymphocyte count was 43 x 10 cells/l at initiation of treatment, and the mean log10 HIV RNA was 5.18 copies/ml. The HIV RNA level was undetectable (< 400 copies/ml) in 88.1, 89.2, 84.2, 75.0 and 69.7% of patients at 3, 6, 12, 18 and 24 months respectively. The cumulative probability of remaining alive was 86.3% at 24 months on treatment for all patients, 91.4% for those with a baseline CD4 lymphocyte count > or =50 x 10 cells/l, and 81.8% for those with a baseline CD4 lymphocyte count < 50 x 10 cells/l. The cumulative probability of changing a single antiretroviral drug by 24 months was 15.1% due to adverse events or contraindications, and 8.4% due to adverse events alone. CONCLUSIONS: ART can be provided in resource-limited settings with good patient retention and clinical outcomes. With responsible implementation, ART is a key component of a comprehensive response to the epidemic in those communities most affected by HIV.
    • Outcomes and safety of concomitant nevirapine and rifampicin treatment under programme conditions in Malawi.

      Moses, M; Zachariah, R; Tayler-Smith, K; Misinde, D; Foncha, C; Manzi, M; Bauerfeind, A; Mwagomba, B; Kwanjana, J; Harries, A D; Médecins sans Frontières, Thyolo District, Thyolo, Malawi. (2010-02)
      SETTING: Thyolo District Hospital, rural Malawi. OBJECTIVES: To report on 1) clinical, immunological and virological outcomes and 2) safety among human immunodeficiency virus (HIV) infected patients with tuberculosis (TB) who received concurrent nevirapine (NVP) and rifampicin (RMP) based treatment. DESIGN: Retrospective cohort study. METHODS: Analysis of programme data, June-December 2007. RESULTS: Of a total of 156 HIV-infected TB patients who started NVP-based antiretroviral treatment, 136 (87%) completed TB treatment successfully, 16 (10%) died and 5 (4%) were transferred out. Mean body weight and CD4 gain (adults) were respectively 4.4 kg (95%CI 3.3-5.4) and 140 cells/mm(3) (95%CI 117-162). Seventy-four per cent of patients who completed TB treatment and had a viral load performed (n = 74) had undetectable levels (<50 copies/ml), while 17 (22%) had a viral load of 50-1000 copies/ml. Hepatotoxicity was present in 2 (1.3%) patients at baseline. Two patients developed Grade 2 and one developed Grade 3 alanine transaminase enzyme elevations during TB treatment (incidence rate per 10 years of follow-up 4.2, 95%CI 1.4-13.1). There were no reported deaths linked to hepatotoxicity. CONCLUSIONS: In a rural district in Malawi, concomitant NVP and RMP treatment is associated with good TB treatment outcomes and appears safe. Further follow-up of patients would be useful to ascertain the longer-term effects of this concurrent treatment.