Evaluation of an antiretroviral treatment cohort in a ressource-limited region in Kenya

Titelblatt, Inhaltsverzeichnis, Lebenslauf, Danksagung, Eidesstattliche Erklärung Einleitung Herleitung der Aufgabenstellung Patienten und Methoden Ergebnisse Diskussion Zusammenfassung LiteraturEinleitung Das Ziel der vorliegenden Untersuchung war die Evaluierung von antiretroviraler Therapie in einer ländlichen, ressourcen-schwachen Region West-Kenias. Methoden Die Therapie war Bestandteil der medizinischen Regelversorgung des Migori-Krankenhauses und wurde vom Krankenhauspersonal durchgeführt. Die Standardtherapie setzte sich aus Stavudin, Lamivudin und Nevirapin zusammen. Der Beobachtungszeitraum umfasste 12 Monate. In regelmäßigen Konsultationen wurden Nebenwirkungen, Therapieansprechen und die Therapieadhärenz untersucht. Die Adhärenz wurde mittels Tablettenzählung, Selbsteinschätzung und einer visuellen Analogskala ermittelt. Einflussfaktoren auf Therapieansprechen, Überleben, Therapieadhärenz, Auftreten von Nebenwirkungen und Therapieabbruch wurden mittels uni- und multivariater Analyse ermittelt. Ergebnisse 159 Patienten hatten eine Therapieindikation und wurden in die Studie aufgenommen, 124 davon begannen eine antiretrovirale Therapie. 22% der Patienten verweigerten eine Therapie, als unabhängige Risikofaktoren wurden niedriger Bildungsstand und, bei Frauen, eine Schwangerschaft identifiziert. 71% der 124 Patienten der Therapiekohorte waren Frauen, der Altersmedian betrug 31 Jahre. Vor Therapiebeginn waren 45% der Patienten im AIDS-Stadium, die CD4 Zellzahl betrug im Median 189/µl, die Viruslast im Median 5,03 log10 und das Ausgangsgewicht im Median 55 kg. Die CD4 Zellzahl stieg nach 6 Monaten Therapie im Median um 121/µl und nach 12 Monaten um 142/µl an, die Viruslast fiel um 2,4 bzw. 2,5 log Stufen und das Körpergewicht nahm um 5 bzw. 4 kg zu. Insgesamt hatten 28% der Patienten nach 6 und 32% der Patienten nach 12 Monaten ein virologisches Therapieversagen (Viruslast <400 k/ml). Eine mittlere Therapieadhärenz von weniger als 95% nach 4 Monaten war signifikant mit einem virologischen Versagen nach 6 Monaten assoziiert. Die Wahrscheinlichkeit, im Beobachtungszeitraum von 12 Monaten erkrankungsfrei zu bleiben oder zu überleben betrug 67,7%. Dabei waren ein niedriges Körpergewicht und eine bestehende AIDS-Erkrankung zu Therapiebeginn unabhängig mit einer Krankheitsprogression unter Therapie assoziiert. Die mittlere Therapieadhärenz betrug nach 12 Monaten 91%, insgesamt hatten 77,6% der Patienten eine Adhärenz >95%. Vorausgehende unzureichende Adhärenz war kontinuierlich über alle Messzeitpunkte hinweg ein signifikanter Risikofaktor für erneute unzureichende Adhärenz. 15% der Patienten brachen die Therapie im Beobachtungszeitraum ab; als unabhängiger Risikofaktor konnte eine unzureichende Adhärenz in den ersten 2 Monaten identifiziert werden. Für niedrigen Bildungsstand ergab sich eine grenzwertig signifikante Assoziation (p=0,05). Im Bezug auf Therapieansprechen, Therapieversagen, Therapieadhärenz und Nebenwirkungen waren keine geschlechtsspezifischen Unterschiede beobachtet worden. Schlussfolgerung Das klinische, immunologische und virologische Therapieansprechen sowie die Adhärenz waren sowohl mit anderen afrikanischen als auch mit Studien aus Industrieländern gut vergleichbar. Durch die verbesserte Betreuung von bestimmen Patientengruppen wie schwangeren Frauen oder Patienten mit niedrigem Bildungsstand und unzureichender Adhärenz ließen sich wahrscheinlich Therapieabbrüche weiter vermindern und die Therapieadhärenz sowie das virologische Therapieansprechen noch verbessern.Introduction The aim of the study was the evaluation of antiretroviral therapy (ART) in a rural, ressource-limited region in Western Kenya. Methods ART was part of the routine health care of the Migori-Hospital and was applied by the health personnel. Standard treatment was Stavudine, Lamivudine and Nevirapin. The follow-up period was 12 months. Within regular consultations side effects, treatment response and adherence were documented. Adherence was measured by pill count, patient self report and visual analogue scale. Factors influencing treatment response, survival, adherence, occurrence of side effects and loss to follow-up were evaluated in univariate and multivariate analysis. Results 159 patients had a treatment indication and were enrolled into the study. 124 patients started ART and 22% denied treatment. A low educational level and in women pregnancy were identified as independent risk factors for treatment denial. 71% of the treated patients were female, the median age was 31 years. At start of ART 45% of the patients had AIDS and the median CD4 cell count was 189/µl. The median viral load was 5.03 log10 and the median weight 55 kg. The CD4 cell count after 6 months of ART increased by a median of 121/ml and after 12 months by 142/µl, the viral load decreased by 2.4 and 2.5 log, respectively. The body weight increased by 5 and 4 kg, respectively. After 6 months of ART, 28% of the patients had a virologic treatment failure (viral load >400 c/ml), after 12 months 32%. A mean adherence of less than 95% after 4 months of ART was significantly associated with virologic treatment failure at 6 months. The probability to survive or to stay free of opportunistic infections during 12 months of follow-up was 67.7%. A low body weight and having AIDS at baseline were independently associated with disease progression under ART. The mean adherence after 12 months of ART was 91%, 77.6% of the patients had an adherence of more than 95%. A history of incomplete adherence was identified as risk factor for repeated non-adherence at each follow-up. During 12 months of ART, 15% of the patients were lost to follow-up; incomplete adherence within the first 2 months of ART was identified as independent risk factor. Additionally, there was a trend for lower educational level to be associated with loss to follow-up (p=0.05). Gender differences were not detected regarding treatment response, treatment failure, adherence and side effects. Conclusion The clinical, immunological and virological treatment response as well as the adherence was comparable to other ART studies from Africa and developed countries. In our setting, targeting adequate counselling to special patient groups such as pregnant women, those with lower educational level and with non-adherence could possibly help to decrease loss to follow-up and to increase adherence and virologic treatment response

Outcome of Different Nevirapine Administration Strategies in Preventing Mother-to-Child Transmission (PMTCT) Programs in Tanzania and Uganda

OBJECTIVE: Prevention-of-mother-to-child transmission (PMTCT) interventions based on single-dose nevirapine (NVP) are widely implemented in Africa, but strategies differ regarding how and when to administer the drug to women and infants. The aim of this study was to analyze the outcome of different strategies with regard to NVP intake in pregnant women and their infants in Tanzania and Uganda. METHODS: In an observational study carried out between March 2002 and December 2004, we compared a directly observed NVP administration strategy in Tanzania (supervised NVP intake for women and infants at a health unit) and a semi-observed administration strategy (self-administered NVP for women at home and supervised intake for infants at a health unit) in Uganda. RESULTS: The proportions of HIV-positive women accepting receipt of NVP from the health units were similar in the 2 countries (42.4% in Tanzania vs 45.6% in Uganda; P = .06). NVP intake in infants was significantly higher in Tanzania than in Uganda (43.7% vs 24.1%; P < .001). In a multivariate analysis, maternal age above 25 years, secondary education, Catholic faith, and having undergone PMTCT counseling at a hospital were independently associated with infant NVP intake. CONCLUSION: In our settings, the directly observed administration strategy resulted in a higher NVP intake in infants. The semi-observed strategy, which implies that, after home delivery, the infant has to be presented to a health unit for NVP administration, was less successful

Wie lässt sich die Eliminierung von Hepatitis B, C und D in Deutschland messen? Ergebnisse eines interdisziplinären Arbeitstreffens

Background!#!In 2016, the World Health Organization (WHO) released a strategy to eliminate hepatitis B, C, and D and defined indicators to monitor the progress. The Robert Koch Institute organized an interdisciplinary working meeting in 2019 to identify data sources and gaps.!##!Objectives!#!The objectives were to network, to create an overview of the data sources available in Germany on hepatitis B and C, and to discuss how to construct indicators.!##!Materials and methods!#!We extracted the WHO indicators relevant for Germany and determined how they can be constructed on the basis of available data. Stakeholders from public health services, clinics, laboratories, health insurance companies, research institutes, data holders, and registries attended a workshop and discussed methods of constructing the indicators for which data are lacking. Data sources and data were evaluated and prioritized with regard to their quality and completeness.!##!Results!#!Indicators on prevalence, incidence, prevention, testing and diagnosis, treatment, cure, burden of sequelae, and mortality for the general population can be constructed using secondary data such as diagnosis, health service, and registry data, data from laboratories and hospitals as well as population-based studies. Data sources for vulnerable groups are limited to studies among drug users, men who have sex with men, and about HIV coinfected patients. Data for migrants, prisoners, and sex workers are largely lacking as well as data on burden of disease from chronic viral hepatitis in the general population.!##!Conclusions!#!We identified data sources, their limitations, and methods for construction for all selected indicators. The next step is to convert the ideas developed into concrete projects with individual stakeholders