WHO Issues Guidelines on HCV Amid Drug Cost Controversy
Authors: Anita Slomski
Journal: JAMA (2014)

In April, the World Health Organization (WHO) issued its first guidelines for diagnosingandtreatinghepatitisCvirus(HCV) infection. Given that the disease affects 130 million to 150 million people worldwide and results in350 000to500 000deathseach year,somehealthpolicyexpertssaytheguidelines are long overdue. Yet until recently, increasingaccesstotreatmentwasn’tahighpriority in many lowand middle-income countries because the available therapies posed somany problems. “Interferon-based medications are very complicated to administer, theyhavehightoxicity,andsuccessrates aren’t great, so it was hard to push for more treatment,”saidStefanWiktor,MD,teamlead of theWHO’s Global Hepatitis Program. However,newdirect-actingantiviralssofosbuvirandsimeprevir,aswellasproteaseinhibitorsboceprevirandtelaprevir,andadozen promising drugs in development have dramaticallyalteredattitudesabouttreatingHCV infection. Cure rates are now greater than 90%for peoplewith somegenotypes of the disease. “Advances are moving forward at lightning speed, andclearlywehavemedications that are very effective, very safe,” said Wiktor. ItwastimefortheWHOtoissueguidelines “to help countries think more strategicallyabouthepatitisCandtoplanthemostappropriate prevention and therapeutic interventions for their epidemics,” he said. Althoughtheguidelinesaretargetedprimarilytowardpolicymakersandphysicians in low-andmiddle-incomecountries, theymay alsoproveuseful inwealthiercountriessuchas theUnitedStates.“Currentlytherearenoother guidelines that take into account the new medications simeprevir and sofosbuvir and werecreatedwiththesamerigorousmethodologiesWHOused,”saidYngveFalck-Ytter,MD, co-chair of theWHOguideline development group,associateprofessorofmedicineatCase Western Reserve University, and director of hepatology and gastroenterology at Louis StokesClevelandVAMedical Center. Although the WHO guidelines make cost-effective recommendations for some aspects of HCV care, they also strongly recommendtreatmentusingsofosbuvir for4of the 6 genotypes of the disease in regimens that either eliminate or reduce the need for pegylated interferon.Sofosbuvir,whichwas approved by the US Food and Drug Administration in December 2013, is priced at $84 000 for a 12-week treatment—$1000 per pill—in the United States. In Egypt, the total cost of sofosbuvir treatment is $900, “which is still tooexpensive,” saidWiktor,but the 99%price reduction demonstrates the power of a government negotiating directly with sofosbuvir drugmaker Gilead. CitingastudyatLiverpoolUniversitythat showsthata12-weekcourseofsofosbuvircan beproducedforas lowas$68,DoctorsWithoutBorders/MedecinsSansFrontieres (MSF) isadvocatingfora$500pricetodiagnoseand treatan individualwithHCVusingsofosbuvir. Sofosbuvirandsimeprevircouldbeproduced generically in India andmarketed at very affordable prices, just like HIV antiretrovirals, saidRohitMalpani, directorofpolicy andadvocacy forMSF’sAccessCampaign.First-line treatmentforHIVtodaycosts less than$200 perpersonperyear—ahugedecreasefromthe $10 000priceofadecadeago.“Thisyear,oppositiontoGilead’ssofosbuvirpatentwasfiled in India, andwe think it has a goodchanceof succeeding,whichmeansthere is realpotential for sofosbuvir tobeavailable as ageneric in developing countries,” said Malpani. “But governments also have to step forward and eitherdemand lowerpricesor take thesteps available to themunder global trade rules to bring down the costs of thesemedicines.” Theexorbitantpriceofmedication isnot the only barrier to HCV treatment in many lowand middle-income countries. “Clearly for theseguidelines tohavean impact, there needs to be a significant increase in resources for HCV screening, laboratory diagnosis, and health care infrastructure,” says Wiktor.Andthat’swhere theguidelineshave politicalvalue.“Groupsthatareadvocatingfor resources in these countries can point to theseguidelinesasanadditional tool tomove countries forwardandputmoreemphasison hepatitis prevention and control,” he said. National governments will also have a greater responsibility to fund HCV treatmentprogramsthanthey’vetakenwithother diseases such asHIV, notedMalpani. “Unlike HIV, hepatitis C is primarily a disease of middle-income countries, and the Global