Recommendations and guidance on hepatitis C virus self-testing

Domizia Salusest |

The World Health Organization (WHO) has recommended that self-testing for hepatitis C virus (HCV) should be made available as an option for HCV testing, to improve rates of hepatitis C diagnosis.

Only 21% of people with hepatitis C have been diagnosed, WHO estimates, and innovations that can expand the availability of testing and improve uptake are urgently needed to reach the WHO target of 80% of eligible people with hepatitis C treated  by 2030.

Although no direct evidence of the effectiveness of hepatitis C self-testing has been published, WHO said that studies of HIV self-testing shows that self-testing can improve the uptake of testing, results in a higher rate of diagnosis than facility-based testing and achieves similar levels of linkage to care when compared to facility-based testing.

Studies of the feasibility of hepatitis C self-testing show that most people carry out the self-test successfully and find self-testing acceptable. Self-testing has the potential to reach people who might otherwise not be tested. WHO says that although the cost per test is higher, more cases can be diagnosed through self-testing.

To implement hepatitis C self-testing, national health systems will need to look at laws and regulations on who can carry out tests, as well as ensure that quality-assured test kits are approved and procured for national programmes.

Community engagement in the development and implementation of HCV self-testing campaigns will be critical for acceptance of self-testing, as well as for generating demand. Peers will also play a key role in the distribution of self-test kits and a wide range of distribution methods must be evaluated. Information for test users and referral pathways also need to be developed.

“HIV self-testing has been an effective tool in accelerating progress towards achieving global goals, and many country programmes have benefited from the availability of HIV self-testing to support continuity of essential services in the COVID-19 context,” said Dr Meg Doherty, Director of the WHO Global HIV, Hepatitis and STI Programmes. “We encourage countries and national programmes to start planning for introduction of HCV self-testing as well, especially for priority populations and regions with the greatest gaps in testing coverage.”

US CDC recommends third dose of Moderna or Pfizer COVID-19 vaccines for organ transplant recipients

Marco Verch. Creative Commons licence.

People who have undergone a solid organ transplant and who received the Pfizer or Moderna COVID-19 vaccines should receive a third dose, the US Centers for Disease Control and Prevention (CDC) recommended this month.

The recommendation also applies to people who are receiving treatment for liver cancer and to people with HIV with low CD4 counts.

The decision follows approval of third doses of the Pfizer and Moderna vaccines by the US Food and Drug Administration. French and British health authorities have already issued recommendations for third booster doses for immunocompromised people and transplant recipients respectively.

The recommendation does not apply to recipients of the Johnson & Johnson single-dose vaccine. CDC said that there are not sufficient data to make a recommendation yet.

Immunocompromised people have weaker responses to vaccination with many types of vaccine.

Immunocompromised people are those who have:

  • been receiving active cancer treatment for tumors or cancers of the blood.
  • received an organ transplant and are taking medicine to suppress the immune system.
  • received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system.
  • moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome).
  • advanced or untreated HIV infection.
  • active treatment with high-dose corticosteroids or other drugs that may suppress your immune response.

Hepatitis C virtually eliminated in people with HIV in the Netherlands

Graph showing the decline in prevalence from Dr Cas Isfordink's IAS 2021 presentation.

Hepatitis C has been almost eliminated as a health problem for people living with HIV in the Netherlands due to direct-acting antiviral treatment, researchers reported last month at the 11th International AIDS Society Conference on HIV Science (IAS 2021) .

In the Dutch national HIV cohort, 25,059 people were eligible for inclusion in the analysis. Chronic hepatitis C prevalence was stable between 2000 and 2014, in the range of 4 to 5%. By 2016, prevalence had fallen to 1.6% after rapid uptake of treatment and fell to 0.6% by 2019.

Turning to treatment uptake, the researchers identified 979 people with chronic hepatitis C infection who had attended an HIV clinic at least once from October 2015 and had at least six months of follow-up data, to allow for the opportunity to start and complete treatment. Just under 8% (72) remained untreated.

By the end of 2020, only 29 people in the Dutch national HIV cohort still had chronic hepatitis C infection. Although all could potentially transmit hepatitis C to others, doctors considered a possible risk existed in only three cases. Their findings suggest that the potential for onward transmission of hepatitis C from people with hepatitis C and HIV co-infection in the Netherlands has been virtually eliminated after very high uptake of treatment.

High hepatitis C cure rate in Thai study of community-based treatment

Wiraporn Srisuwanwattana, USAID. Creative Commons licence.

Community-based testing and treatment for HIV and hepatitis C achieved high hepatitis C cure rates in Thailand, results from the Thai C-FREE study show.

Tanyapom Wansom presented results from the C-FREE cohort study of community-based HIV and hepatitis C testing and treatment in Thailand, at the 11th International AIDS Society Conference on HIV Science (IAS 2021) last month.

The C-FREE study was designed to evaluate the uptake of HIV and viral hepatitis testing and treatment in people who use drugs and their sexual partners in Thailand. Testing and treatment were delivered in community settings offering harm reduction services in four cities in Thailand. The model of care is designed to eliminate barriers to treatment and provide services in settings that people who use drugs feel comfortable to visit.

C-FREE is a prospective cohort study that offers testing for HIV, hepatitis B and hepatitis C every three months. An open-label treatment study provides 12 weeks of treatment with the pangenotypic regimen of generic sofosbuvir/velpatasvir for anyone diagnosed with hepatitis C apart from people with decompensated cirrhosis or liver cancer.

The C-FREE cohort has enrolled 1322 people since May 2019, mainly referred by community outreach. The hepatitis C treatment sub-study enrolled 667 people, of whom ten died or were lost to follow-up before completing treatment and follow-up testing. Of the 667 people who started treatment, 549 completed treatment, 445 were evaluated for sustained virologic response and 424 achieved a sustained virologic response.

Japanese study shows benefits of treating hepatitis C early

Curing hepatitis C in people with mild fibrosis by the age of 50 reduces their risk of death to the same level as the rest of the population, Japanese researchers report in the Journal of Viral Hepatitis.

Dr Takashi Kumada of Gifu Kyoritsu University, Japan, and colleagues investigated the long-term outcomes of 1243 people with hepatitis C diagnosed between 1995 and 2017 who had at least three years of follow-up, no history of liver cancer and a FIB-4 score of 1.45 or less, indicating mild fibrosis.

In the study population, 657 people were cured of hepatitis C: 337 on an interferon-based regimen and 320 on a direct-acting antiviral regimen (the clearance group). The remaining 586 had not started treatment by December 2017 (the no clearance group).

Clearance of hepatitis C (presence of HCV RNA) reduced the risk of hepatocellular carcinoma by 73%, of all-cause mortality by 65% and of liver-related mortality by 75%.

When the mortality rate was compared by age group, people who achieved hepatitis C clearance before the age of 50 did not have a significantly higher all-cause mortality rate compared to the general population (1.7% vs 0% at 20 years). Nor did people who achieved clearance after the age of 70 (3.1% vs 1%).

The findings underscore the importance of early detection and treatment of hepatitis C to maximise the health gains of curing hepatitis C with direct-acting antiviral treatment.

Food insecurity raises the risk of death in people with fatty liver disease

Ani Kardashian at the EASL International Liver Congress 2021.

Food insecurity – limited or unreliable food supplies due to poverty – was associated with an increased risk of death in US adults with non-alcoholic fatty liver disease (NAFLD) or advanced fibrosis caused by NAFLD, an analysis of a large US cohort study has shown.

Dr Ani Kardashian, Assistant Professor of Clinical Medicine at the University of Southern California, presenting the findings to the International Liver Congress in June, said that one in five deaths in adults with advanced fibrosis living in poverty could be prevented if food insecurity were eliminated.

Food insecurity is defined by nutritional researchers as the limited or uncertain availability of nutritionally adequate foods or the inability to acquire food in socially acceptable ways. It disproportionally affects low-income and socially marginalised adults. Food insecurity tends to be accompanied by a reduction in the quality and variety of foods, followed by a reduction in food intake.

Approximately 35 million adults in 18 million households in the US were experiencing some degree of food insecurity before the COVID-19 pandemic. Job losses during the pandemic may have pushed the number of people who are food insecure towards 50 million over the past year, Prof. Kardashian said.

To investigate the long-term outcomes of people with fatty liver disease and food insecurity, Prof. Kardashian and colleagues carried out a retrospective cohort study of participants in the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2014.

During a median follow-up period of 85 months, food-insecure participants had a higher rate of all-cause mortality (p < 0.001) and multivariate analysis adjusted for gender, ethnicity, other socio-demographic and metabolic risk factors, showed that food insecurity was associated with a 46% higher risk of death in adults with NAFLD.

Food insecurity was also associated with an increased risk of death in participants with advanced fibrosis during a median follow-up period of 56 months (p = 0.04). Multivariate analysis adjusted for gender, ethnicity, other socio-demographic and metabolic risk factors showed that food insecurity was associated with a 37% higher risk of death in adults with advanced fibrosis.

The researchers also calculated the population-attributable risk percentage, or the percentage of deaths that would be averted if food insecurity were eliminated. Three per cent of deaths would be averted if food insecurity were eliminated in participants with NAFLD, rising to 7% of deaths in participants with advanced fibrosis and more than one in five deaths in participants with advanced fibrosis living in poverty.

Speaking to a press briefing on the study, Prof. Kardashian said that the impact on mortality of interventions to reduce food insecurity should be investigated. Screening for food insecurity, referral to food counselling and linkage to food assistance should be considered in any clinical practice treating patients with NAFLD, she suggested. Partnering with food banks to improve nutrition for people with NAFLD should also be explored. “It’s important that we expand food assistance for our at-risk patients,” Prof. Kardashian concluded.

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