Minimal monitoring of hepatitis C treatment is safe and effective

Hepatitis C treatment with no monitoring visits during treatment is safe and leads to a high cure rate, an international study reported on Monday at the online AASLD Liver Meeting.

The study was designed to investigate how treatment might be delivered in lower-income settings as countries attempt to scale up access to direct-acting antiviral treatment for hepatitis C.

Apart from cost, there are several barriers to expanding hepatitis C treatment in lower-income settings. Genotyping and monitoring tests may cost more than a course of direct-acting antiviral treatment and require laboratory capacity that may not exist in some regions. Frequent monitoring also places a burden on the healthcare infrastructure and on patients who may need to pay transport costs to attend, missing work while they do so.

A "simple and safe" model of hepatitis C treatment that cuts monitoring and clinic visits to a minimum has the potential to expand the number of people who can be treated. To test whether minimum monitoring is safe and delivers cure rates equivalent to standard monitoring, the AIDS Clinical Trials Group designed the MINMON study (ACTG 5360), a single-arm, non-randomised study.

Dr Sunil Solomon of Johns Hopkins University School of Medicine reported results from the MINMON study in an online late-breaker presentation on Monday.

The MINMON study recruited 400 participants at 38 sites in five countries (Brazil, South Africa, Thailand, Uganda and the United States). The study excluded people with a previous history of hepatitis C treatment, pregnant women, people with decompensated cirrhosis and people co-infected with hepatitis B. Most study participants were recruited in the United States (132), Brazil (131) or Thailand (110).

Study participants received a fixed-dose regimen of sofosbuvir/velpatasvir once daily for 12 weeks and attended the clinic twice: once to collect all study medication and give blood for laboratory tests and once to undergo viral load monitoring 12 weeks after completing treatment. Participants were contacted by phone at week 4 to check on adherence and possible side effects and once at week 22 to remind them of the post-treatment monitoring visit.

The study population had a median age of 47 years, 35% were female and 6% transgender. Forty-two per cent were White, 28% Asian and 18% Black. Almost half the study population (42%) was co-infected with HIV and all but two had a fully suppressed viral load on antiretroviral treatment. Approximately one-third (31%) had a history of injecting drugs and 6% were currently injecting drugs.

During the study period, healthcare staff were able to contact 99% of participants at week 4 and 84% at week 22. Two participants discontinued treatment, one due to side effects and one due to loss of medication. Fifteen participants needed to make unscheduled clinic visits during the study, three of these due to adverse events.

Ninety-five per cent of study participants achieved a sustained virologic response, or cure. Of the remainder, two were lost to follow-up, one attended outside the study visit window and 17 had detectable HCV RNA at the follow-up visit. Among those with detectable HCV RNA, 12 reported 100% adherence to treatment and samples are being evaluated to determine whether these participants experienced reinfection rather than virologic non-response.

There was no significant difference in response by sub-group except for an inferior response in people aged 20-29 years (8% of participants), in whom the cure rate fell to 85%.

Treatment was well tolerated; no serious adverse events were attributable to study drugs and only eight adverse events of any type were reported during treatment (diarrhoea, headache, fatigue and abdominal distension) although one adverse event led to treatment discontinuation.