'I saw it as a second chance': A qualitative exploration of experiences of treatment failure and regimen change among people living with HIV on second- and third-line antiretroviral therapy in Kenya, Malawi and Mozambique.

Increasing numbers of people living with HIV (PLHIV) in sub-Saharan Africa are experiencing failure of first-line antiretroviral therapy and transitioning onto second-line regimens. However, there is a dearth of research on their treatment experiences. We conducted in-depth interviews with 43 PLHIV on second- or third-line antiretroviral therapy and 15 HIV health workers in Kenya, Malawi and Mozambique to explore patients' and health workers' perspectives on these transitions. Interviews were audio-recorded, transcribed and translated into English. Data were coded inductively and analysed thematically. In all settings, experiences of treatment failure and associated episodes of ill-health disrupted daily social and economic activities, and recalled earlier fears of dying from HIV. Transitioning onto more effective regimens often represented a second (or third) chance to (re-)engage with HIV care, with patients prioritising their health over other aspects of their lives. However, many patients struggled to maintain these transformations, particularly when faced with persistent social challenges to pill-taking, alongside the burden of more complex regimens and an inability to mobilise sufficient resources to accommodate change. Efforts to identify treatment failure and support regimen change must account for these patients' unique illness and treatment histories, and interventions should incorporate tailored counselling and social and economic support

Implementation of fixed-dose combination therapy for secondary prevention of atherosclerotic cardiovascular disease among Syrian refugees in Lebanon: a qualitative evaluation.

BACKGROUND: We report findings of a qualitative evaluation of fixed-dose combination therapy for patients with established atherosclerotic cardiovascular disease (ASCVD) attending Médecins Sans Frontières (MSF) clinics in Lebanon. Cardiovascular disease is a leading cause of death and disability worldwide, and humanitarian actors are increasingly faced with the challenge of providing care for chronic diseases such as ASCVD in settings where health systems are disrupted. Secondary prevention strategies, involving 3-5 medications, are known to be effective for patients at risk of heart attack or stroke, but supply and adherence are challenging in humanitarian settings. Fixed dose combination therapy, combining two or more medications in one tablet, may be a strategy to address this. METHODS: The evaluation was nested within a prospective mixed-methods study in which eligible ASCVD patients were followed for 1 year during (i) 6 months of usual care then (ii) 6 months of fixed dose combination (FDC) therapy. After 1 year, we conducted in-depth interviews with a purposive sample of patients, MSF staff and external stakeholders. Interviews focused on acceptability and sustainability of the fixed dose therapy intervention. Interview data were analysed thematically, informed by thea Theoretical Framework of Acceptability. Additional attention was paid to non-typical cases in order to test and strengthen analysis. RESULTS: Patients and health care providers were positive about the FDC intervention. For patients, acceptability was related to ease of treatment and trust in MSF staff, while, for staff, it was related to perceived improvements in adherence, having a good understanding of the medication and its use, and fitting well with their priorities for patient's wellbeing. External stakeholders were less familiar with FDC therapy. While external clinicals expressed concerns about treatment inflexibility, non-clinician stakeholder interviews suggested that cost-effectiveness would have a major influence on FDC therapy acceptability. Sustainability was tied to the future role of MSF care provision and coherence with the local health system. CONCLUSIONS: For patients and clinic staff, FDC was an acceptable treatment approach for secondary prevention of ASCVD disease in two MSF clinics in Lebanon. Sustainability is more complex and calls for better alignment of care with public systems

Drug-resistant tuberculosis in HIV-infected patients in a national referral hospital, Phnom Penh, Cambodia

Background and objective: There are no recent data on the prevalence of drug-resistant tuberculosis (DR TB) in Cambodia. We aim to describe TB drug resistance amongst adults with pulmonary and extra-pulmonary TB and human immunodeficiency virus (HIV) co-infection in a national referral hospital in Phnom Penh, Cambodia. Design: Between 22 November 2007 and 30 November 2009, clinical specimens from HIV-infected patients suspected of having TB underwent routine microscopy, Mycobacterium tuberculosis culture, and drug susceptibility testing. Laboratory and clinical data were collected for patients with positive M. tuberculosis cultures. Results: M. tuberculosis was cultured from 236 HIV-infected patients. Resistance to any first-line TB drug occurred in 34.7% of patients; 8.1% had multidrug resistant tuberculosis (MDR TB). The proportion of MDR TB amongst new patients and previously treated patients was 3.7 and 28.9%, respectively (p<0.001). The diagnosis of MDR TB was made after death in 15.8% of patients; in total 26.3% of patients with MDR TB died. The diagnosis of TB was established by culture of extra-pulmonary specimens in 23.6% of cases. Conclusions: There is significant resistance to first-line TB drugs amongst new and previously treated TB–HIV co-infected patients in Phnom Penh. These data suggest that the prevalence of DR TB in Cambodia may be higher than previously recognised, particularly amongst HIV-infected patients. Additional prevalence studies are needed. This study also illustrates the feasibility and utility of analysis of non-respiratory specimens in the diagnosis of TB, even in low-resource settings, and suggests that extra-pulmonary specimens should be included in TB diagnostic algorithms

Fixed dose combination drugs for cardiovascular disease in a prolonged humanitarian crisis in Lebanon: an implementation study.

OBJECTIVES: This pre-post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting. SETTING: Two Médecins sans Frontières (MSF) primary care clinics serving Syrian refugee and host populations in north Lebanon. PARTICIPANTS: Consenting patients ≥18 years with existing ASCVD requiring secondary prevention medication were eligible for study enrolment. Those with FDC contraindication(s) or planning to move were excluded. Of 521 enrolled patients, 460 (88.3%) were retained at 6 months, and 418 (80.2%) switched to FDC. Of these, 84% remained on FDC (n=351), 8.1% (n=34) discontinued and 7.9% (n=33) were lost to follow-up by month 12. INTERVENTIONS: Eligible patients, enrolled February-May 2019, were switched to Trinomia FDC (atorvastatin 20 mg, aspirin 100 mg, ramipril 2.5/5/10 mg) after 6 months' usual care. During the study, the COVID-19 pandemic, an economic crisis and clinic closures occurred. OUTCOME MEASURES: Descriptive and regression analyses compared key outcomes at 6 and 12 months: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) and systolic blood pressure (SBP) control. We performed per-protocol, intention-to-treat and secondary analyses of non-switchers. RESULTS: Among 385 switchers remaining at 12 months, total adherence improved 23%, from 63% (95% CI 58 to 68) at month 6, to 86% (95% CI 82 to 90) at month 12; mean non-HDL-C levels dropped 0.28 mmol/L (95% CI -0.38 to -0.18; p<0.0001), from 2.39 (95% CI 2.26 to 2.51) to 2.11 mmol/L (95% CI 2.00 to 2.22); mean SBP dropped 2.89 mm Hg (95% CI -4.49 to -1.28; p=0.0005) from 132.7 (95% CI 130.8 to 134.6) to 129.7 mm Hg (95% CI 127.9 to 131.5). Non-switchers had smaller improvements in adherence and clinical outcomes. CONCLUSION: Implementing an ASCVD secondary prevention FDC improved adherence and CVD risk factors in MSF clinics in Lebanon, with potential for wider implementation by humanitarian actors and host health systems

Fixed dose combination drugs for cardiovascular disease in a prolonged humanitarian crisis in Lebanon: an implementation study

Objectives This pre–post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting.Setting Two Médecins sans Frontières (MSF) primary care clinics serving Syrian refugee and host populations in north Lebanon.Participants Consenting patients ≥18 years with existing ASCVD requiring secondary prevention medication were eligible for study enrolment. Those with FDC contraindication(s) or planning to move were excluded. Of 521 enrolled patients, 460 (88.3%) were retained at 6 months, and 418 (80.2%) switched to FDC. Of these, 84% remained on FDC (n=351), 8.1% (n=34) discontinued and 7.9% (n=33) were lost to follow-up by month 12.Interventions Eligible patients, enrolled February–May 2019, were switched to Trinomia FDC (atorvastatin 20 mg, aspirin 100 mg, ramipril 2.5/5/10 mg) after 6 months’ usual care. During the study, the COVID-19 pandemic, an economic crisis and clinic closures occurred.Outcome measures Descriptive and regression analyses compared key outcomes at 6 and 12 months: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) and systolic blood pressure (SBP) control. We performed per-protocol, intention-to-treat and secondary analyses of non-switchers.Results Among 385 switchers remaining at 12 months, total adherence improved 23%, from 63% (95% CI 58 to 68) at month 6, to 86% (95% CI 82 to 90) at month 12; mean non-HDL-C levels dropped 0.28 mmol/L (95% CI −0.38 to −0.18; p&lt;0.0001), from 2.39 (95% CI 2.26 to 2.51) to 2.11 mmol/L (95% CI 2.00 to 2.22); mean SBP dropped 2.89 mm Hg (95% CI −4.49 to −1.28; p=0.0005) from 132.7 (95% CI 130.8 to 134.6) to 129.7 mm Hg (95% CI 127.9 to 131.5). Non-switchers had smaller improvements in adherence and clinical outcomes.Conclusion Implementing an ASCVD secondary prevention FDC improved adherence and CVD risk factors in MSF clinics in Lebanon, with potential for wider implementation by humanitarian actors and host health systems

Long-term outcomes of a pediatric HIV treatment program in Maputo, Mozambique: a cohort study

Objective: To describe long-term treatment outcomes of a pediatric HIV cohort in Mozambique. Design: Retrospective analysis of routine monitoring data. Setting: Secondary health care facilities in the Chamanculo Health District of Maputo. Subjects: A total of 1,335 antiretroviral treatment (ART) naïve children <15 years of age enrolled in HIV care between 2002 and 2010. Intervention: HIV care, ART (since 2003), task shifting to lower cadre nurses, counseling by lay counselors, active patient tracing, nutritional support, support by a psychologist, targeted viral load testing, and switch to second-line treatment. Main outcome measures: Kaplan–Meier estimates for retention in care (RIC), CD4 cell percentage, body mass index for age z-score, and adjusted incidence rate ratios for attrition (death or loss to follow-up) as calculated by Poisson regression. Results: The RIC at 6 years in the pre-ART cohort was 44% (95% confidence interval: 38–49), and the one at 8 years in the ART cohort was 70% (64–75). Risk factors for attrition included young age, low CD4 percentage, underweight, active tuberculosis, and enrollment/treatment initiation after 2006. The mean CD4 percentage increased strongly at 1 year on treatment and remained high thereafter. The body mass index for age z-score sharply increased at 1 year after treatment initiation before stabilizing at pre-ART levels thereafter. Conclusions: Good clinical and immunological treatment outcomes up to 8 years of follow-up on ART can be achieved in a context of shortage of health workers and a high level of task-shifting approach

HIV-associated Kaposi’s sarcoma in Maputo, Mozambique: outcomes in a specialized treatment center, 2010–2015

Abstract Background Kaposi’s sarcoma (KS) is a common HIV-associated malignancy associated with disability, pain and poor outcomes. The cornerstone of its treatment is antiretroviral therapy, but advanced disease necessitates the addition of chemotherapy. In high-income settings, this often consists of liposomal anthracyclines, but in Mozambique, the first line includes conventional doxorubicin, bleomycin and vincristine, which is poorly-tolerated. Médecins Sans Frontières supports the Ministry of Health (MOH) in a specialized HIV and KS treatment center at the Centro de Referencia de Alto Maé in Maputo. Methods We performed a retrospective analysis of data collected on patients enrolled at the CRAM between 2010 and 2015, extracting routinely-collected clinical information from patient care databases. KS treatment followed national guidelines, and KS staging followed AIDS Clinical Trials Group and MOH criteria. Baseline description of the cohort and patient outcomes was performed. Risk factors for negative outcomes (death or loss to follow-up) were explored using Cox regression. Results Between 2010 and 2015, 1573 patients were enrolled, and 1210 began chemotherapy. A majority were young adult males. At enrollment, CD4 was < 200 cells/μl in 45% of patients. Among patients receiving chemotherapy, 78% received combination doxorubicin-bleomycin-vincristine. Among patients receiving chemotherapy, 43% were lost to follow-up and 8% were known to have died. In multivariate regression, the only risk factors identified with poor outcomes were CD4 < 100 cells/μl at enrollment (Risk ratio 1.5, 95%CI 1.1–2.1, p = 0.02 and having S1 disease (RR 1.7, 95%CI 1.2–2.3, p = 0.001). Discussion We describe a large cohort of patients receiving care for HIV-associated KS in a specialized clinic in an urban setting. Outcomes were nonetheless unsatisfactory. Efforts should be made to decrease late referrals and entry into care and to increase access to more effective and better-tolerated treatments like liposomal doxorubicin

Prevention of mother-to-child transmission of hepatitis B virus in antenatal care and maternity services, Mozambique

Objective: To pilot an intervention on the prevention of mother-to-child transmission (PMTCT) of hepatitis B virus (HBV) in an antenatal care and maternity unit in Maputo, Mozambique, during 2017-2019. Methods: We included HBV in the existing screening programme (for human immunodeficiency virus (HIV) and syphilis) for pregnant women at their first consultation, and followed mother-child dyads until 9 months after delivery. We referred women who tested positive for hepatitis B surface antigen (HBsAg) for further tests, including hepatitis B e antigen (HBeAg) and HBV viral load. According to the results, we proposed tenofovir for their own health or for PMTCT. We administered birth-dose HBV vaccine and assessed infant HBV status at 9 months. Findings: Of 6775 screened women, 270 (4.0%) were HBsAg positive; in those for whom data were available, 24/265 (9.1%) were HBeAg positive and 14/267 (5.2%) had a viral load of &gt; 200 000 IU/mL. Ninety-eight (36.3%) HBsAg-positive women were HIV coinfected, 97 of whom were receiving antiretroviral treatment with tenofovir. Among HIV-negative women, four had an indication for tenofovir treatment and four for tenofovir PMTCT. Of 217 exposed liveborn babies, 181 (83.4%) received birth-dose HBV vaccine, 160 (88.4%) of these &lt; 24 hours after birth. At the 9-month follow-up, only one out of the 134 tested infants was HBV positive. Conclusion: Our nurse-led intervention highlights the feasibility of integrating PMTCT of HBV into existing antenatal care departments, essential for the implementation of the triple elimination initiative. Universal birth-dose vaccination is key to achieving HBV elimination.Piloter une action de prévention d'une transmission de la mère à l'enfant (PTME) du virus de l'hépatite B (VHB) dans une maternité et unité de soins prénataux à Maputo, au Mozambique, entre 2017 et 2019.Nous avons inclus le VHB dans le programme existant visant à dépister le virus de l'immunodéficience humaine (VIH) et la syphilis chez les femmes enceintes lors de leur première consultation. Nous avons également suivi les dyades mère-enfant jusqu'à 9 mois après l'accouchement. Nous avons orienté les femmes positives à la présence de l'antigène de surface (HBsAg) de l'hépatite B vers d'autres tests, dont ceux détectant l'antigène e (HBeAg) et la charge virale du VHB. En fonction des résultats, nous avons proposé un traitement au ténofovir pour leur propre santé ou pour la PTME. Enfin, nous avons administré un vaccin contre le VHB à la naissance et évalué le statut sérologique du nourrisson à neuf mois.Sur 6775 femmes dépistées, 270 (4,0%) étaient positives au HBsAg; parmi celles pour qui des données étaient disponibles, 24/265 (9,1%) étaient positives au HBeAg et 14/267 (5,2%) présentaient une charge virale supérieure à 200 000 UI/ml. Le VIH a en outre été détecté chez 98 (36,3%) femmes positives au HBsAg, 97 d'entre elles faisant l'objet d'un traitement antirétroviral au ténofovir. Parmi les femmes négatives au VIH, quatre avaient reçu des indications de traitement au ténofovir et quatre s'étaient vu conseiller le ténofovir dans le cadre d'une PTME. Sur les 217 bébés exposés, 181 (83,4%) ont été vaccinés contre le VHB à la naissance, 160 (88,4%) d'entre eux moins de 24 heures après leur venue au monde. Lors de la visite de suivi neuf mois après la naissance, seul un des 134 nourrissons testés était positif au VHB.Notre action dirigée par le personnel infirmier démontre qu'il est possible d'intégrer la PTME du VHB dans les départements de soins prénataux existants, une démarche essentielle à la mise en œuvre de l'initiative de triple élimination. La vaccination universelle à la naissance est cruciale pour éradiquer le VHB.(c) 2022 The authors; licensee World Health Organization.Realizar una intervención piloto sobre la prevención de la transmisión maternofilial (PTMF) del virus de la hepatitis B (VHB) en una unidad de asistencia prenatal y maternidad en Maputo, Mozambique, entre 2017 y 2019.Se incluyó el VHB en el programa existente de cribado del virus de la inmunodeficiencia humana (VIH) y de la sífilis para las embarazadas en su primera consulta, y se realizó un seguimiento de las parejas maternofiliales hasta nueve meses después del parto. Se derivó a las mujeres que dieron positivo en la prueba del antígeno de superficie del virus de la hepatitis B (AgHBs) para que se sometieran a otras pruebas, como el antígeno e del virus de la hepatitis B (AgHBe) y la concentración vírica del VHB. Según los resultados, se propuso tenofovir como medida sanitaria o para la PTMF. Por último, se administró la vacuna contra el VHB al nacer y se evaluó el estado serológico del VHB en los lactantes a los nueve meses.De las 6775 mujeres analizadas, 270 (4,0 %) dieron positivo en la prueba del AgHBs; entre las que disponían de datos, 24/265 (9,1 %) eran positivas en la prueba del AgHBe y 14/267 (5,2 %) tenían una concentración vírica superior a 200 000 UI/ml. Noventa y ocho (36,3 %) mujeres con AgHBs positivo estaban coinfectadas por el VIH, 97 de las que recibían tratamiento antirretrovírico con tenofovir. Entre las mujeres con VIH negativo, cuatro tenían indicación de tratamiento con tenofovir y cuatro con tenofovir para la PTMF. De los 217 bebés nacidos vivos expuestos, 181 (83,4 %) recibieron la vacuna contra el VHB al nacer, 160 (88,4 %) de ellos en las primeras 24 horas de vida. En la visita de seguimiento a los nueve meses, solo uno de los 134 lactantes analizados dio positivo en la prueba del VHB.Esta intervención dirigida por enfermeras demuestra la viabilidad de integrar la PTMF del VHB en los departamentos de asistencia prenatal existentes, lo que es esencial para la aplicación de la iniciativa de triple eliminación. La vacunación universal al nacer es fundamental para lograr la erradicación del VHB.(c) 2022 The authors; licensee World Health Organization