The multi-country open-label trial TAC ANRS 12311 evaluated a tailored care model for treating and re-treating Hepatitis C (HCV) across multiple countries. The study demonstrated that this model achieved success in treatment acceptance, safety, and efficacy rates in Sub-Saharan Africa. These findings suggest that scaling up point-of-care HCV testing and sustained virological response (SVR) assessment, along with community-based education initiatives, could significantly advance the region's goal of eliminating HCV.
The study enrolled 120 participants, among them 36 were co-infected with HIV, and 14 had cirrhosis. There was minimal treatment discontinuation, as only one participant stopped treatment due to relocation. No deaths or severe adverse events were recorded. The sustained virological response at 12 weeks post-treatment (SVR12) rates was excellent, with 89% of all participants achieving SVR12: specifically, 90% for genotypes 1 or 2, and 88% for genotype 4. Among the participants who required retreatment (n = 13), all achieved SVR12.
“First, our study found high SVR rates after 12 weeks, comparable to SVR rates obtained in other African regions or among migrants from SSA. In those studies, such high SVR rates were shown to be associated with high self-reported adherence rates to DAAs,” the investigators continue. “Secondly, slightly (but not significant) reduced effectiveness was observed for patients with GT-4 or cirrhosis; however, retreatment with a different combination resulted in SVR at Week 12 of the second-line treatment.”1
Main Takeaways
- The TAC ANRS 12311 trial demonstrated the effectiveness of a tailored care model, incorporating viral load monitoring and educational sessions, in achieving high rates of treatment acceptance, safety, and efficacy for HCV in Sub-Saharan Africa.
- Scaling up access to point-of-care HCV testing, SVR assessment, and community-based education efforts is critical to meeting WHO’s target of eliminating HCV by 2030 in Sub-Saharan Africa.
- Addressing challenges such as outdated treatment guidelines and disruptions from factors like the COVID-19 pandemic is essential for sustaining progress and improving HCV care across the region.
Between November 2015 and March 2017, treatment-naïve patients with HCV, excluding those with decompensated cirrhosis or liver cancer, were enrolled in the study. Participants underwent a 12-week treatment regimen tailored to their genotype: sofosbuvir + ribavirin for genotype 2 and sofosbuvir + ledipasvir for genotype 1 or 4. Patients who did not respond to initial treatment underwent retreatment with sofosbuvir + velpatasvir + voxilaprevir. The primary outcome assessed was SVR12. Secondary outcomes included treatment adherence, safety, and SVR12 rates in cases requiring retreatment.
The investigators finish off, “Finally, the third and equally important result is that this study confirms that HCV cure is possible in these settings when HCV care and treatment are free for all patients and when it is possible to offer a second-line treatment in case of virological failure with the first-line treatment. The latter result indirectly underlines how these findings advocate for a universal and free model of HCV care for all patients living with chronic HCV infection in SSA. Such a model of care can be implemented and scaled up in a test-and-treat strategy to achieve the World Health Organization HCV elimination goal by 2030.”1
The study limitations start with its design before the recommendation for pan-genotypic treatments as first-line therapy. Also, the COVID-19 pandemic disrupted data collection due to lockdowns in the trial countries. Lastly, the study did not specifically address the challenges of delivering HCV care to remote or rural populations.
A previous study published in The Lancet discusses access to reimbursement for direct-acting antivirals (DAAs) is globally uneven, with low and middle-income countries (LMICs) facing lower rates of reimbursement compared to high-income nations. DAAs for HCV infection offer high response rates (>95%) and have simplified HCV treatment management, allowing non-specialist healthcare providers to treat patients without advanced liver disease. To align with WHO objectives for the elimination of HCV, it is essential to support countries, especially LMICs, in enhancing access to DAA reimbursement and eliminating barriers to reimbursement.2
These findings indicate suboptimal levels of DAA reimbursement across countries where these treatments are registered, with significant regional variation in access. They observed that fewer DAAs were reimbursed in regions such as central Asia, the Caribbean, Pacific Island Countries and Territories, and sub-Saharan Africa compared to other countries. The Lancet study highlights disparities in reimbursement influenced by differing development and approval timelines for DAAs, particularly disadvantaging LMICs.2
The TAC ANRS 12311 trial emphasizes the effectiveness of tailored HCV treatment in Sub-Saharan Africa. To achieve WHO’s HCV elimination goal by 2030, improving access to point-of-care testing and treatment, supported by community-based education efforts, is essential. Overcoming current challenges like updating treatment guidelines and managing external factors like the COVID-19 pandemic is important for sustainable progress in HCV care across the region.
References
Lacombe K, Moh R, Chazallon C, et. Al. Feasibility, safety, efficacy and potential scaling-up of sofosbuvir-based HCV treatment in Central and West Africa: (TAC ANRS 12311 trial). Scientificreports. Published May 3, 2024. Accessed June 19, 2024. https://www.nature.com/articles/s41598-024-57013-1
