Direct acting agents used against hepatitis C infection are clinically effective and reliable.
EATG, the pan-European network of communities of people living with and affected by hepatitis C (HCV) and HIV point out that current direct acting agent (DAA) treatment options against hepatitis C infection, which provide a cure to 95-97% of patients carrying HCV, are effective and useful from an epidemiological and public health perspective. The patient community is alarmed by the reception and interpretation of the recent Cochrane review of these treatment options, and sees these interpretations as harmful, single-sided and misleading.
Brussels, 15 June 2017 – EATG as the issuer of this statement, representing communities of people living with and affected by HCV and HIV, doctors and scientists addressing HIV and co-infections in Europe, are extremely concerned about the reception and interpretation of the recent Cochrane review of direct acting agent (DAA) treatment options against HCV infection. A recent article published in the Guardian suggests that these treatment options are not clinically effective and do not provide an economically viable option against HCV.
A follow-up open letter from leading clinicians in the field, also published in the Guardian, points out some of the arguments that the patient community supports. We would like to express the patient community’s gratitude to the authors of this letter for standing up for their patients and the fight against the HCV epidemic.
We agree that the methodology of the Cochrane review is not suitable for determining the effectiveness of DAA treatment, and it moreover ignores some key factors such as the survival and improved quality of life of patients cured from chronic HCV infection. It also ignores epidemiological aspects, notably that DAA treatments provide a cure for HCV infection; this offers the possibility of stopping the HCV epidemic and even of eliminating it by reducing the number of patients living with the virus, a desirable possibility raised by several international organisations including the WHO.
We recognise that the Cochrane review observes the methodological traditions that contribute to the consistency and reliability of their findings across longer time periods. What we find especially concerning is the simplistic interpretation of the findings as it happened in the Guardian. Monitoring the reception of the review in the public and the patient communities, we find that these interpretations not only may deter patients from seeking life-saving and effective treatment, but also provide arguments for health policy decision-makers against funding and reimbursing these effective and proven treatment options on the basis of misinterpreted and flawed results.
Our main objections to the recent development are based on several arguments:
- There is scientific evidence that sustained virological response (SVR) reduces mortality almost four-fold;
- In a prospective clinical trial of patients with HCV-CV, DAA-based therapy restored disturbances in peripheral B- and T-cell homeostasis.
- Antiviral treatment for F0F1 patients at baseline should be considered due to (i) an evolution to severe fibrosis in at least 15%, (ii) a better response to treatment (SVR achieved in 48%), (iii) an improved survival in patients with SVR compared to those without SVR demonstrated in both F0F1 and F≥2 groups.
- The Cochrane review refers to the lack of evidence for clinical effectiveness. However, the lack of evidence does not mean that there is a lack of effect.
- Most of the studies included in the review were not originally designed to measure improved mortality and quality of life after achieving SVR, so a review of these studies could never show such clinical efficacy.
- A large proportion of the studies included in the review were studies of DAAs that never entered the market.
In many countries, the current prices of DAA treatment regimens are unreasonably and unjustifiably high. Patient communities have invested years of work and advocacy into making sure that treatment regimens are accessible and become available to as many patients as possible. In countries like Portugal and Australia, concentrated efforts have led to price agreements that are sustainable in the long run. It is painfully detrimental and ill-advised if scientific evidence is misunderstood, skewed and misinterpreted to support policy and economic arguments that ultimately harm the patient community and public health.
As so far, the signatories of this statement and patient communities around the world will do all we can to stop and reverse the HCV epidemic. Most of us either lived or are living with hepatitis C, and our lived experience of survival, better quality of life, lower mortality and better general health is ignored by the methodology used in the Cochrane review and the public interpretations thereof.
We also hope that better access to DAA treatment options can be ascertained through methods other than dissuading patients, clinicians and health policy makers from a treatment that has been proven effective, easy and reliable, albeit incomprehensibly expensive. People living with or affected by hepatitis C deserve better.
Read or download the full statement here: Patient statement on DAA Cochrane report