Dutch Association of HIV-Treating Physician guidelines: update following ‘revolutionary’ new hepatitis C drugs

 

Treatment of hepatitis C (HCV) has changed dramatically during the past year with the arrival of a number of revolutionary drugs. These drugs now offer short and effective HCV treatment, with very few side effects. In response to these changes, the Dutch Association of HIV-Treating Physicians (Nederlandse Vereniging HIV Behandelaren, NVHB)  has recently amended their guidelines for the treatment of HIV/HCV co-infections. We spoke to the NVHB chair, Dr Marc van der Valk, and infectious disease specialist, Dr Clemens Richter, about these changes and the impact of these new drugs on the HIV/HCV co-infected population.

Improved drug therapy

Two new HCV drugs, sofosbuvir and simeprevir, became available in the Netherlands at the end of 2014, followed by daclatasvir in March this year. The availability of these revolutionary drugs means that a large number of HCV patients could now be successfully cured of their HCV infection within just 12 or 24 weeks. Both HIV-treating physicians are extremely pleased with the arrival of these new HCV drugs. Not only is the duration of HCV treatment far shorter, but side effects are also minimal, explains Dr Richter: “You can’t compare the side effects with those seen with interferon-based combinations. I’m not just hearing this from my patients – the whole country is talking about it.” Dr van der Valk adds: “What we are seeing now is truly revolutionary and it’s fantastic to be part of it all. We have people who, after various failed treatments, have been waiting 10 years for a treatment that really works. We  also know from Stichting HIV Monitoring’s research that around 60% of people with an HIV/HCV co-infection have already had prior treatment on at least one occasion. It’s great that we can now offer these people a solution with barely any side effects!”.

However, the new drugs are not yet available for everyone. “Currently, interferon-free treatment is only available for patients with severe liver fibrosis. Liver fibrosis is measured using a fibroscan, which is a very elegant solution. People who do not yet have liver fibrosis cannot be prescribed sofosbuvir. And since sofosbuvir is included in all the treatment combinations, there are few options for people without liver fibrosis,” explains Dr van der Valk. “We are also limited in terms of HIV patients who are co-infected with HCV genotype 3 and who have liver fibrosis”, continues Dr Richter. “Hopefully the recently-registered drug daclatasvir in combination with sofosbuvir will offer more options for genotype 3, but for now this combination is not reimbursed by health insurers”, says Dr van der Valk.  He goes on to say: “As HIV-treating physicians, we feel treatment should be made more broadly available. In particular, in the group of HIV/HCV co-infected patients, HCV can be sexually transmitted and progression to liver fibrosis takes place more quickly. Therefore, timely treatment is of great importance in these patients. But whether the drugs will be made more widely available is up to the government”.

Changes to the guidelines

New drugs mean new guidelines. As such, the NVHB’s guidelines for HIV/HCV co-infections are a living document and have been updated on the basis of the American guidelines, but with local adjustments such as the inclusion of notes on the reimbursement status in the Netherlands. According to Dr van der Valk “the most important difference is that daclatasvir has not yet been approved in America, while it has been approved in the Netherlands. We have therefore added daclatasvir to our guidelines. On the other hand, the sofosbuvir and ledipasvir combination and the Abbvie 3D combination are reimbursed in the US, but not yet in the Netherlands. We hope this will change after the summer.”

HCV drugs and cART

Although the HCV drugs are very effective, they do interact with other medication. “They all have interactions with one or more HIV inhibitors, but also with drugs such as those that lower blood pressure or treat prostate problems. It is therefore highly important that we know what drugs patients are taking alongside their HIV inhibitors”, explains Dr van der Valk. Dr Richter goes on to add: “Luckily the appropriate dose-adjustments for particular drugs have been clearly described. In a worst case scenario, given the short treatment duration for these new HCV drugs, you could even choose to leave out certain drugs known to be likely to interact”. In HIV-infected individuals, information on drug interactions and treatment results are closely monitored by Stichting HIV Monitoring.

Eradicating HCV

With these improved drug therapies, the obvious question is whether eradication of HCV is possible in the Netherlands. Although both doctors remain cautious, there’s also a hint of hope in their voices. “Eradication requires a very active approach in which people who are as yet unaware of their HCV status are identified. Although we know the HCV status of most HIV patients, there remain cases of HCV infections outside this group, for example in ex-drug users. It also depends greatly on a broadening of the indication of these new HCV drugs. If this happens, eradication would become a more realistic possibility”, says Dr Richter. “Moreover, you need to take into account that in people with HIV, HCV can also be sexually transmitted. So you also need to treat those people with whom HIV/HCV co-infected people have been in contact. This means that, besides identifying and treating these people, it is very important to focus on increasing awareness of HCV. If you don’t treat everyone immediately, there will always be a risk of reintroduction”, adds Dr van der Valk.

 

The NVHB guidelines on the preferred treatment for HIV/HCV co-infected patients can be consulted by clicking on this link.