In accordance with the WHO goal of eliminating HCV as a public health threat by 2030, countries worldwide are expanding access to HCV diagnosis and treatment services (8). However, to ensure HCV elimination, these programs must complete the full cascade of care for HCV in a timely fashion. Among the 666 patients who were identified as anti-HCV positive during the September 2019 screening campaign, only 222 had their SVR12 results returned by March 2021. The two biggest gaps in the cascade of care were return of initial viral load results and the return of SVR12 results. During the September 2019 screening campaign, viral load samples were collected on the same day as RDT administration. Consequently, we believe that missing or delayed initial viral load results could be explained by poor communication between the health facilities and the testing hub. The proportion of patients whose SRV12 test results were returned was even lower (56.3%), which likely reflects both poor communication between health facilities and viral load hubs and challenges in following up with patients for sample collection. This aligns with the findings from Nsanzimana et al., where 34% of patients who completed HCV treatment were found to either be lost to follow-up for SVR12 assessment or to not having HCV RNA results returned (7). These gaps point to a need to improve the overall laboratory communication and turnaround time, which has previously been reported to be an important element impacting provider performance and patient care(16, 17).
Although viral load testing was a barrier to provision of care, our treatment initiation and treatment assessment rates were quite high. These outcomes were achieved in the context of a mobile clinical campaign, which has previously been reported as a low-cost strategy to support linkage to care, and may be a scalable model for improving patients’ access to care (13).
Similarly, among patients whose SVR12 results were returned, we found that HCV cure rate was very high (93.5%). This level slightly exceeds levels previously reported in Rwanda among treatment naïve patients with non-cirrhotic or with compensated cirrhosis treated with ledipasvir 90mg/sofosbuvir 40mg (87%) (18) and among a combination of treatment naïve and experienced patients treated through the national program (92%) (7). Our results reinforce previous findings that treatment for HCV can be successfully implemented in low-income countries and among individuals living in limited resources settings (19).
Among patients who completed treatment, it took over 14 months to complete the full HCV cascade of care. In general, the time to complete individual stages of the cascade of care compares favorably to what has been reported in other similar settings. For example, while in our study the median time to receive initial viral load results was 15 days, in Malawi’s HIV program, the median turn-around time is almost three months (20). Our median time between return of initial viral test results and treatment assessment (104 days) is very similar to what has been reported in an HCV program at a tertiary hospital in the USA (107 days) (21) and better than what was found in another HCV program at a tertiary care centre in the USA (300 days) (22). However, these studies were conducted in routine care settings, while our data reflects treatment initiation following a mass screening campaign and targeted mobile clinic outreach program to support decentralized care. In Rwandan settings where HCV infected patients do not have access to this targeted, decentralized outreach program, gaps in the cascade of care are likely even larger and delays in service provision are likely even longer than reported here. Addressing these delays will be critical for Rwanda to achieve its national target of treating 90% of those infected with HCV by 2024.
We proposed three indicators for assessing timely provision of hepatitis C care: a) proportion of initial HCV viral load results returned ≤ 30 days of screening among people who screened RDT+; b) proportion of patients who were assessed for treatment eligibility ≤ 90 days after receiving a viral load results among those with a detectable viral load; and c) proportion of SVR12 results returned ≤ 210 days of treatment initiation among patients who initiated treatment. In a health system where each of these indicators are met, a patient could expect to complete treatment for HCV in less than 11 months from screening. A second strategy that could reduce turn-around time for lab results and eliminate the risk of poor communication between testing hubs and health facilities is the introduction of point of care tests to assess hepatitis C viraemia. There are currently two major approaches to providing point of care testing. The first replaces viral RNA test with core antigen tests, which can provide results in 60 minutes (23–25). Core antigen tests have been approved by the WHO as an alternative for confirmatory viral load testing (26, 27), and may also provide an alternative approach for assessing SRV12 (28).
The second uses GeneXpert to provide point-of-care viral load testing. Similar applications of GeneXpert have achieved success in HIV programs in limited-resource settings, as they allow patients to receive viral load results on the same day as sample collection (19), and have been successfully used in HCV pilot programs in Egypt (29), Indonesia (30), and Tanzania (31). Given that HCV GeneXpert is WHO pre-qualified for HCV viral load testing, it provides an opportunity for improving HCV patients monitoring and would also allow for integrated multi-disease testing platforms (32).
Our study has some limitations. First, our results are not fully generalizable as they focused on catchment areas for two district hospitals that receive substantial support from PIH/IMB. As noted, these catchment areas were serviced by a targeted mobile clinic to support HCV treatment initiation during the study period. As discussed above, we anticipate that this limitation means that the observed gaps or delays in care provision in our setting would be lower than elsewhere in Rwanda. Second, the cascade of care for the patients in our study was interrupted by the COVID-19 pandemic. However, most patients were initiated through the mobile clinic program, which was active between November 2019 and January 2020 and preceded the COVID-19-related national lockdown in Rwanda, which occurred between 14th March 2020 and 3rd May 2020. Furthermore, SRV12 follow-up for most patients should have occurred between January and March 2021, during which time no lockdowns or restrictions on intra-district travel were in place and patients should have had uninterrupted access to their local health facilities. Third, our study used routine clinical records, which are subject to missing data, particularly on dates for steps of cascade of care. However, we assessed the sensitivity of our results to missing data and did not find that it meaningfully changed our results. Fourth, our recommended quality of care indicators, “Proportion of SVR12 results returned ≤ 210 days of treatment initiation among patients who initiated treatment” does not account for the fact that some patients could have been prescribed a 24 week course of treatment and would not be eligible to receive SRV12 testing until at least 270 days after treatment initiation. Treatment duration was not readily available from our clinical database, however, based on previous estimates of higher APRI (Aspartate Aminotransferase to Platelet Ratio Index) score among people initiating HCV treatment elsewhere in Rwanda (15), we believe that fewer than ten percent of patients were prescribed a 24 week-course treatment. In the interest of proposing a single indicator that would be easy to implement for the monitoring of future programs, we do not recommend disaggregating this indicator by treatment duration.