Hepatitis B treatment

Treatment of hepatitis B is recommended for people who are showing signs of an active infection and progressive liver damage. Current therapies can suppress viral load, improve liver inflammation and reduce the risk of developing cirrhosis and liver cancer. Unlike hepatitis C, hepatitis B cannot be cured with current treatments in the vast majority of cases. Instead, people with hepatitis B may need to take treatment with an antiviral drug for an indefinite period.

Tenofovir continues to suppress hepatitis B virus for eight years

At the recent American Association for the Study of Liver Diseases (AASLD) Liver Meeting, in Boston, researchers reported on the results of eight years of treatment with tenofovir, a nucleotide analogue. The study found that of those who joined the trial, 75% of HBeAg-negative participants and 58% of HBeAg-positive participants had viral suppression after eight years of follow-up, with no evidence of long-term side-effects.

Entecavir and tenofovir in drug-resistant hepatitis B virus

If the hepatitis B virus is not fully suppressed during antiviral treatment, it is prone to develop resistance to the antiviral drug being used, especially in the case of lamivudine. Since lamivudine is used frequently as the first-line treatment for hepatitis B in settings where resources are limited, it is important to have evidence of the effectiveness of second-line treatment. The ENTEBE trial evaluated the safety and efficacy of entecavir plus tenofovir combination therapy for 144 people with chronic hepatitis B who had experienced previous nucleoside/nucleotide treatment failure. The study found that 85% of those who joined the study had fully suppressed hepatitis B viral load after 96 weeks of treatment.

Adding pegylated interferon to tenofovir

The most favourable response to hepatitis B treatment is loss of hepatitis B surface antigen (HBsAg). Loss of HBsAg occurs in a very small proportion of people taking currently available treatment. The likelihood of antigen loss is improved by adding a course of treatment with pegylated interferon for people taking tenofovir. A 740-person study comparing various durations of additional treatment with pegylated interferon in people receiving standard treatment with tenofovir found that people who received a 48-week course of pegylated interferon and tenofovir were more likely to experience HBsAg loss after 72 weeks of follow-up. Nine per cent of patients in this arm of the study experienced HBsAg loss, compared to approximately 2% in those who received either 16 weeks of pegylated interferon plus tenofovir, or pegylated interferon alone.

In seven cases HBsAg reappeared after having been cleared, indicating that it may be premature to consider HBsAg loss as evidence of a ‘cure’ for hepatitis B without lengthy follow up. A cure is considered more likely when there is a full HBsAg seroconversion, with HBsAg loss and the development of protective anti-HBs antibodies.

New antiviral treatments which might enable a large proportion of people with hepatitis B to be cured of infection are being developed by at least five companies.

Cost of hepatitis C treatment

An earnings statement from Gilead Sciences and a deal struck in Portugal show that the price of hepatitis C treatment is beginning to fall – contradicting predictions from financial analysts prior to the launch of Harvoni and Viekira Pak in the United States. Gilead Sciences revealed last week that it anticipates an average discount of 46% on the list price set for Harvoni at the time of launch.

Meanwhile the Portuguese Ministry of Health has negotiated one of the largest discounts yet disclosed on the European price of sofosbuvir (Sovaldi). Gilead Sciences has agreed to sell sofosbuvir to the Portuguese government at a price of 25,000 euros to treat 13,000 patients over the next three years – a discount of over 50% on the European list price. A similar price has been agreed in Spain. Unspecified discounts have been negotiated with German insurers too.

However, the cost of hepatitis C treatment will leave a cure out of reach for millions of people with hepatitis C. A study previously presented at international conferences, and published this month in the journal Hepatology, estimates that direct-acting antivirals for hepatitis C could be produced by generic manufacturers for as little as $122 for a course of treatment. A petition from the Hep Coalition calling on Gilead Sciences to expand the number of countries able to benefit from lower-priced generic versions of its hepatitis C drugs is online at PetitionBuzz.

Activist guide to treatment access

Activist Strategies for Increasing Access to HCV Treatment in Low- and Middle-Income Countries is a new guide published by Treatment Action Group. It presents a number of key strategies through real-world case studies and shows how strategies used to combat the HIV epidemic can be – and have been – adapted to increase hepatitis C treatment access. In three sections it covers: laying the groundwork through community organising; overcoming cost barriers to hepatitis C treatment access; and collaborating with researchers to build the case for hepatitis C treatment access.

UNITAID guide to detection and monitoring of hepatitis C

UNITAID, the international fund for purchase of drugs and diagnostics for HIV, tuberculosis (TB) and malaria, is exploring how it can use its purchasing power to incentivise the development of new tests for hepatitis C virus (HCV). A new guide to tests for the detection and monitoring of hepatitis C finds that, although current diagnosis and screening options for the disease remain too complex and expensive for widespread scale up, there are some emerging technologies which could change this situation.

In the longer term, identification of people with hepatitis C is also important to help build the market intelligence that will be necessary to encourage new drug manufacturers to enter the market and enable treatment options to be made more affordable and accessible, especially for the newly developed highly effective medicines. UNITAID has already started investing to make some of these new medicines more affordable for those in need.

The report also describes some of the challenges associated with implementing HCV testing in low-resource settings, where factors like cost, infrastructure requirements and the need for trained laboratory technicians limit tests’ availability.

Merck delay

Merck has been told by the US Food and Drug Administration (FDA) that it will not receive an accelerated review of its two-drug, interferon-free hepatitis C combination. FDA rescinded the ‘breakthrough’ status for grazoprevir and elbasvir because, meanwhile, other efficient and safe hepatitis C antivirals are available. The decision could delay US approval of the combination treatment by two to three months, until early 2016.

24th International Harm Reduction Conference – call for papers

The 24th International Harm Reduction Conference will take place in Kuala Lumpur, Malaysia, in October 2015.

The online process for submitting papers is now open, and will remain open until 27th March 2015.

Hepatitis C treatment factsheets

We have recently published a new factsheet on daclatasvir (Daklinza), an addition to the four other hepatitis C treatment factsheets.

Each factsheet focuses on one direct-acting antiviral drug and gives an overview of how it works, who can use it, how it is taken, what trial results tell us about how effective it is, known side-effects and drug interactions.

The factsheets are available to read online, and are also designed to be printed and shared.

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