Access to hepatitis C medicines

Abstract

Hepatitis C is a global epidemic. Worldwide, 185 million people are estimated to be infected, most of whom live in low- and middle-income countries. Recent advances in the development of antiviral drugs have produced therapies that are more effective, safer and better tolerated than existing treatments for the disease. These therapies present an opportunity to curb the epidemic, provided that they are affordable, that generic production of these medicines is scaled up and that awareness and screening programmes are strengthened. Pharmaceutical companies have a central role to play. We examined the marketed products, pipelines and access to medicine strategies of 20 of the world’s largest pharmaceutical companies. Six of these companies are developing medicines for hepatitis C: AbbVie, Bristol-Myers Squibb, Gilead, Johnson & Johnson, Merck & Co. and Roche. These companies employ a range of approaches to supporting hepatitis C treatment, including pricing strategies, voluntary licensing, capacity building and drug donations. We give an overview of the engagement of these companies in addressing access to hepatitis C products. We suggest actions companies can take to play a greater role in curbing this epidemic: (i) prioritizing affordability assessments; (ii) developing access strategies early in the product lifecycle; and (iii) licensing to manufacturers of generic medicines.

Impaired Gastric Cancer Survival in Patients with Inflammatory Bowel Disease

“…Furthermore, telaprevir and boceprevir are first generation DAAs that have lost market share in view of the advent of more effective and better tolerable new generation DAAs. However, these drugs continue to be used in economically deprived countries that use PegIFN as a backbone for CHC therapy [46,47].…”

Proteases and protease inhibitors in infectious diseases

“…The high dose burden, reduced efficacy due to development of resistance, narrow spectrum of genotype activity, and intolerable side effects of the first‐generation HCV protease inhibitors necessitated the search for better molecules, as a result the second‐generation drugs were developed. Subsequently, the poor demand for the first‐generation drugs due to the availability of newer hepatitis C drugs with superior efficacy and side effect profiles coupled with the fact that they are no longer recommended by the World Health Organization (WHO) has caused the developers of both drugs to discontinue their production …”

“…Subsequently, the poor demand for the firstgeneration drugs due to the availability of newer hepatitis C drugs with superior efficacy and side effect profiles coupled with the fact that they are no longer recommended by the World Health Organization (WHO) has caused the developers of both drugs to discontinue their production. 201,202…”

Predictable threats to public health through delaying universal access to innovative medicines for hepatitis C: a pharmaceutical standpoint

“…In the absence of strong national programmes based on universal healthcare coverage and/or of major externally funded programs, most treatment providers in LMICs are private for profit: a market that is highly fragmented, difficult to monitor, and undemanding in terms of quality assurance. Some of the existing generic DAAs are or will be manufactured under the unilateral voluntary license agreement of Gilead for sofosbuvir and ledipasvir , which to our knowledge does not include mandatory WHO Prequalification or SRA registration . Bristol‐Myers Squibb's daclatasvir will be manufactured under voluntary license agreements negotiated through the Medicines Patent Pools (MPP) which requires WHO Prequalification or SRA approval .…”