Treatment with tesamorelin, a synthetic growth hormone-releasing hormone, reduced liver fat content and reduced the progression of liver fibrosis in people with HIV who had non-alcoholic fatty liver disease, researchers report in the journal The Lancet HIV this month.

Non-alcoholic fatty liver disease (NAFLD) – the accumulation of fat in the liver – is a growing cause of liver disease in people living with HIV. The authors of the study published this week say that NAFLD will soon become the greatest cause of liver-related ill health and deaths in people living with HIV, as more people are cured of hepatitis C.

By stimulating the production of growth hormone, tesamorelin also promotes an increase in levels of insulin-line growth factor (IGF-1), which promotes lipolysis (the breakdown of fats).

A previous study showed that tesamorelin reduced liver fat content over six months of follow-up.

In this study, 60 people were randomised to receive tesamorelin or placebo for 12 months.

Tesamorelin treatment was associated with a 37% reduction in liver fat. Just over a third of people in the tesamorelin group (35%) experienced a reduction of hepatic fat below 5% by 12 months, so that they were no longer classified as having NAFLD, compared to 4% of the placebo group.

Tesamorelin recipients were significantly less likely to experience progression of fibrosis (10% vs 37% in the placebo group).

The investigators say that further studies are needed to find out if the effects on liver fat and fibrosis persist after discontinuation of treatment, and when to initiate treatment with tesamorelin.

In July we reported that the London Joint Working Group on Substance Use and Hepatitis C had called on the government to allow pharmacist prescribing of direct-acting antivirals, after a pilot study of testing for chronic hepatitis C virus (HCV) infection at community pharmacies.

Full results of the pilot study have now been published.

The pilot found that 78% of people using needle and syringe programmes in community pharmacies in London who opted to test for hepatitis C would prefer to receive their hepatitis C treatment from the pharmacy.

The second phase of the study tested the use of a point-of-care HCV RNA assay to diagnose chronic HCV infection without the need for referral to a hospital for further testing.

Sixty of the 66 people who tested positive for HCV RNA in the study were referred for secondary care, of whom 21 attended appointments and 18 started treatment.

The researchers are unable to explain the low attendance at secondary care appointments by people diagnosed with chronic HCV infection, but say that pharmacies might have been able to persuade people to attend appointments if there had been better communication between secondary care and pharmacies about who had attended and who had missed appointments.

The study also found that almost 30% of people who tested for hepatitis C were unaware of new interferon-free oral treatment for hepatitis C. The researchers recommend that an information campaign targeting people who inject drugs should convey the message that highly effective oral interferon-free treatment for hepatitis C is now available, to improve uptake of testing.

Sci-B-Vac, an investigational vaccine that contains three different hepatitis B virus (HBV) proteins, may offer more protection, especially for older adults, than widely used existing vaccine options, according to late-breaking study results presented at the recent IDWeek 2019 conference in Washington, DC.

Some adults who receive the standard three-dose HBV vaccine series do not achieve full protection, meaning they do not produce adequate levels of antibodies against the virus. This is more likely among older individuals and people with weakened immune systems. Further, the titre of protective anti-HBs antibodies has been shown to wane over time. Most experts assume that protection against hepatitis B is still present even in these cases, and revaccination is not universally recommended any more. However, it is not entirely certain whether low antibody titres could still make some people at high risk vulnerable to HBV infection years after they were immunised.

Sci-B-Vac, from VBI Vaccines, is a trivalent vaccine containing three HBV antigens: small S plus two larger viral surface proteins known as pre-S1 and pre-S2. Studies to date have shown that the combination induces more rapid and more complete protection, especially for people at risk for poor response to monovalent vaccines, and it may do so at a lower dose.

An experimental two-part vaccine was not able to prevent chronic hepatitis C virus (HCV) infection in a mid-stage study, according to a presentation at the recent IDWeek 2019 conference in Washington, DC. (Preliminary results were reported in the infohep bulletin in June 2019).

The study included 455 participants age 18 to 45 who were at risk for HCV through injection drug use.

The overall incidence of HCV infection after six months of follow-up was 13 cases per 100 person-years. Incidence was lower than expected, likely because study participants in both arms received counselling and referral to syringe programmes, addiction treatment and other harm reduction services.

However, the study found no difference between vaccine and placebo arms in the likelihood of developing chronic infection, with 14 cases in both groups.

The results are disappointing and underline how much still needs to be learnt about how to achieve immunity to hepatitis C. For example, although up to 25% of people who are exposed to hepatitis C will clear the virus within the first few months of infection and form antibodies, these antibodies do not protect against subsequent infection. Similarly, people who are cured of hepatitis C retain antibodies to the virus but are not protected against reinfection.

Although the study did not show effectiveness, it did show that it is possible to conduct a large hepatitis C vaccine study in people who inject drugs, the population at highest risk of hepatitis C infection and priority candidates for any vaccine that might be developed in the future. Learning how to retain people who are using drugs in vaccine trials for hepatitis C will be an important part of the search for an HCV vaccine.

The US Centers for Disease Control and Prevention (CDC) report that the prevalence of hepatitis C in pregnant women in the United States increased by 400% between 2000 and 2015, with the highest prevalence of hepatitis C in women with opioid use disorder.

Research in Louisville, Kentucky – an area seriously affected by the explosion in opioid abuse in the US – also reported this month, shows that almost half of those who tested positive for hepatitis C virus (HCV) antibodies in 2018 were under 40 years of age, compared to 33% in 2016. Without interventions to reduce HCV transmission through injecting drug use, this demographic shift is likely to continue say the investigators. Whereas physicians think of the typical person with hepatitis C as an older male, they may be overlooking a growing number of young men who need screening and treatment for hepatitis C in the United States.

An early-stage safety study of a new hepatitis B drug was halted after two healthy volunteers developed acute hepatitis, Fierce Biotech reports. The further development of the drug, an oral capsid inhibitor called AB-506, was stopped. Drug developer Arbutus Biopharma says it has more compounds active against hepatitis B in development and plans to press on with further trials.

Brazil’s Public Defender has asked the Brazilian competition regulator to investigate Gilead Sciences over a huge increase in the price of its hepatitis C drug sofosbuvir following a patent grant in January, Folha de São Paulo reports. Gilead has increased the price of sofosbuvir from $16 to $240, after fighting a patent case last year to prevent the Brazilian government from buying a generic version of sofosbuvir.

In November, infohep will be providing news coverage from The Liver Meeting 2019, organised by the American Association for the Study of Liver Diseases (AASLD). The conference is taking place in Boston, USA from 8-12 November.

We will be publishing news online and the November infohep bulletin will be dedicated to news from the conference.

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