Efficacy of Helicobacter pylori eradication regimens in Rwanda: a randomized controlled trial

Background: Successful H. pylori treatment requires the knowledge of local antimicrobial resistance. Data on the efficacy of H. pylori eradication regimens available in sub-Saharan Africa are scant, hence the optimal treatment is unknown. Our goals were to determine the efficacy of available regimens in Rwanda as well as evaluate the effect of treatment on health-related quality of life (HRQoL) in patients undergoing esophagogastroduodenoscopy. Methods: This is a randomized controlled trial conducted from November 2015 to October 2016 at a tertiary hospital in Rwanda. Enrollees were 299 patients (35% male, age 42 ± 16 years (mean ± SD)) who had a positive modified rapid urease test on endoscopic biopsies. After a fecal antigen test (FAT) and HRQoL assessment by the Short Form Nepean Dyspepsia Index (SF-NDI) questionnaire, patients were randomized 1:1:1:1 to either a triple therapy combining omeprazole, amoxicillin and one of clarithromycin/ciprofloxacin/metronidazole or a quadruple therapy combining omeprazole, amoxicillin, ciprofloxacin and doxycycline. All therapies were given for a duration of 10 days. The outcome measures were the persistence of positive FAT (treatment failure) 4 to 6 weeks after treatment and change in HRQoL scores. Results: The treatment success rate was 80% in the total population and 78% in patients with a history of prior triple therapy. Significant improvement in HRQoL in the total group (HRQoL mean scores before and after treatment respectively: 76 ± 11 and 32 ± 11, p < 0.001) and the group with functional dyspepsia (HRQoL mean scores before and after treatment respectively: 73 ± 11 and 30 ± 9, P < 0.001) was observed across all treatment groups. Using clarithromycin based triple therapy (standard of care) as a reference, the group treated with metronidazole had worse HRQoL (p = 0.012) and had a trend towards worse treatment outcome (p = 0.086) compared to the ciprofloxacin based combination therapies. Conclusion: Clarithromycin and ciprofloxacin based combination therapies are effective and safe to use alternatively for H. pylori eradication and improve HRQoL. Among the regimens studied, metronidazole based triple therapy is likely to be clinically inferior. Trial registration The clinical trial was retrospectively registered ( PACTR201804003257400 ) with the Pan African Clinical Trial Registry database, on April 6th, 2018 in South Africa.Medicine, Faculty ofPharmaceutical Sciences, Faculty ofOther UBCNon UBCPopulation and Public Health (SPPH), School ofReviewedFacult

Improved quality of life following direct‐acting antiviral treatment for chronic hepatitis C infection in Rwanda: Results from a clinical trial in sub‐Saharan Africa (the SHARED study)

Around 71 million people are living with chronic hepatitis C virus (HCV) infection, with approximately 14% residing in Sub‐Saharan Africa. Direct acting anti‐viral (DAA) therapies offer clear benefits for liver‐related morbidity and mortality, and data from high‐income settings suggest that DAA treatments also provide significant benefits in terms of health‐related quality of life (HRQL). In this study, we assessed the effect of DAA treatment on HRQL for individuals treated for HCV in a clinical trial in Rwanda. We assessed the HRQL of participants using an 83‐question composite survey at Day 0 (‘baseline’) and Week 24 (‘endpoint’). Data were analyzed in R. 296 participants were included in this analysis. Their ages ranged from 19‐90 and 184 (62.2%) were female. There were significant improvements from baseline to endpoint median scores for all physical and mental quality of life sub‐scales. Additionally, a reduction – before and after treatment ‐ in the proportion of those classified as depressed and needing social support was statistically significant (both p<0.001). Economic productivity increased after treatment (p<0.001) and households classified as food secure increased from baseline to endpoint (p<0.001). These results demonstrate that Rwandans with chronic HCV infection experience both clinical and HRQL benefits, including household level benefits like substantial gains in workforce stability, economic productivity, and poverty alleviation, from DAA treatment. A stronger demonstration of accurate and broader household level benefits achieved through treatment of HCV with DAAs will help financing and investment for HCV in resource‐constrained settings become an urgent priority