Hepatitis: Will new evidence for "same-day test and treat" be a game-changer?

Shobha Shukla / Bobby Ramakant *

Nalinikanta Raj Kumar (CoNE) at 24th International AIDS Conference (AIDS 2022)

A new study published last month in the Journal of Hepatology can prove to be a game-changer as it provides strong evidence that “same-day test and treat model” for hepatitis is feasible and possible. In the light of this strong evidence, if governments have to keep their promise to end viral hepatitis by 2030, there must be no delay in fully making this model a reality for every person who needs hepatitis-care.

One of the reasons why people dropped out of hepatitis-related care was the long-time gap between the screening test to initiating treatment (for those who need it). “Earlier, the turnaround time from sample collection to getting the report of hepatitis C viral load test was 30-45 days. This was one of the major treatment access barriers. Now, this time has been reduced to 5-7 days,” said Nalinikanta Raj Kumar, one of the co-authors of the study, who has spearheaded Community Network for Empowerment (CoNE).

“Same-day test and treat” model is the best possible way forward to ensure that people who opt for hepatitis screening are able to continue along the healthcare pathway. "Unless we replicate this model under the National Viral Hepatitis Control Programme, treatment uptake will remain low," said Nalinikanta, who presented this model at 24th International AIDS Conference (AIDS 2022) too.

All happens in about 8 hours

Pilot testing this same-day test and treat model in Manipur, India (Manipur is an Indian state bordering Myanmar which is hard-hit by hepatitis and HIV both), the researchers screened people for hepatitis B and hepatitis C viruses.

Those who were found positive for hepatitis C antibody, were offered the viral load test (Molbio TrueNat point-of-care nucleic acid amplification test), and those who were eligible for treatment as per the national guidelines, were initiated on sofosbuvir and daclastasvir on the same day.

Those who tested negative for hepatitis B were offered vaccine for the same on 0, 7 and 21 days as per WHO guidelines.

Samples of those who were positive for hepatitis B (surface antigen) were sent to referral laboratories for hepatitis B viral load DNA test and followed up as per the national guidelines of National Viral Hepatitis Control Programme of Government of India.

In this pilot study of same-day test and treat:

* 95% of eligible participants at the study site, were screened for hepatitis B and C.

* 40% of them were found to be positive for hepatitis C antibody, all of whom got their hepatitis C RNA viral load test done, after which 61.5% were found positive for hepatitis C (RNA). 96% of these had viremia and were initiated on standard treatment of sofosbuvir and daclastasvir on the very same day.

* Median time from screening to HCV treatment initiation was 8 hours and 12 minutes.

* 6.1% of those screened for hepatitis B were positive (for surface antigen). 97% of those with negative result were not previously vaccinated for hepatitis B so they were offered the vaccine - and all of them took at least the first dose of the hepatitis B vaccination.

Hope lies when people rise-up

“The prevalence of hepatitis C virus infection among people who inject drugs in the state capital of Manipur, India, is 65%. However, access to and uptake of hepatitis C care is poor, largely due to lengthy pre-treatment processes. That is why we piloted a community-led, comprehensive, simplified hepatitis care model that includes same-day hepatitis C virus testing and treatment initiation (“test and treat”) at drug rehabilitation centres in Manipur, to expand access to care for chronic hepatitis,” reads this study publication.

Testing for hepatitis C virus involves few steps: first, screening is done for hepatitis C antibodies. But this test will not distinguish between acute, chronic or resolved hepatitis C infection. That is why all those who test positive for hepatitis C antibody, are offered hepatitis C RNA viral load test using technologies such as RT-PCR or molecular test (or nucleic acid amplification test) such as Gene Xpert or TrueNat. Hepatitis C viral load test will confirm those with acute and chronic infection of hepatitis C, and exclude those whose infection has got resolved.

In Manipur, viral load tests are only available in the state capital Imphal. Machines to do viral load tests (TrueNat machines) are available but trained and dedicated human resource to manage these are not available.

“Since the programme was launched in Manipur in 2019, the number of people on hepatitis C treatment has been very low,” points out Nalinikanta Raj Kumar of CoNE.

Kumar has been part of several community-led initiatives to improve hepatitis and HIV care in Manipur. One of them is the ongoing Community Treatment Observatory process, which was set up in early 2021 with support from International Treatment Preparedness Coalition (ITPC) and TREAT Asia programme.

The phase-1 report of Community Treatment Observatory has already had a positive impact on HIV and hepatitis programmes in the state. One of the impacts has been to shorten the turnaround time of hepatitis C RNA viral load test report from 30-45 days to 5-7 days. Now, new evidence for “same-day test and treat” model will hopefully impact change. Another positive change is that the process for recruiting community peers in the hepatitis care services is moving forward.

Another obstacle reported by those in need for hepatitis care is the mandatory requirement to have a government-issued identity card to access care and services, including hepatitis-C treatment. HIV and hepatitis C co-infection is common, so confidentiality issues hover along with the reality that everyone does not possess a government-issued identity card.

Community treatment observatory process has been an empowering one for most affected communities. “People felt reassured that they can access Legal Aid Clinic to file legal complaints against human rights violations – which includes right to health. At the same time, we got an opportunity to raise awareness among the communities about their rights and responsibilities as per the National Viral Hepatitis Control Programme,” shared Nalinikanta.

Dolutegravir-based antiretroviral therapy regimens for people with HIV are preferred choice in India too as per the guidelines. Community treatment observatory process was an opportunity to raise treatment literacy so that those who have not yet switched over from older regimen to dolutegravir-based regimens, may do so.

TB and HIV

Tuberculosis (TB) is not only the most common opportunistic infection among people living with HIV but also a major cause of death. That is why TB prevention needs to be centre-stage of TB response as well as of HIV programmes.

TB preventive therapy protects people who have latent TB (not active TB disease) from progressing towards active TB disease. But people with HIV (some of them may have hepatitis co-infection too) need to be fully aware of the importance to take TB preventive therapy when offered. This is another area where Nalinikanta feels he has been able to impact change.

“Bedaquiline and Delamanid stocks are available under the National TB Elimination Programme of government of India, but instead of giving these medicines they are giving the injectable medicine, Kanamycin, for those who require treatment for drug-resistant TB. The WHO has already recommended moving away from Kanamycin to non-injectable medicines-based regimen, but the National TB Elimination Programme is still giving out injectables-based therapy for those with multidrug-resistant TB,” rues Nalinikanta.

Making integrated care accessible

In light of the scientific evidence for "same-day test and treat" model for hepatitis care, it is paramount for the National Viral Hepatitis Control Programme to not delay scaling this up so that same-day test and treat care is available everywhere in India. Not doing this will be counter-productive for the oft-chanted slogan of 'Health For All' as well as for sustainable development.