Missing the Target #5: Improving AIDS Drug Access ... - CD8 T cells

ChinaBy anonymous Missing the Target teamAccess to second-line drugs and pediatric treatmentThere is still extremely limited access to second-line ARVs in China. Governmenttreatment authorities are in the process of slowly rewriting the national treatmentguidelines to include second-line treatment; a rough draft of that documentincluded lopinavir/ritonavir + tenofovir + lamivudine (LPV/r+TDF+3TC) as astandard second-line regimen. However, it is still impossible to purchase tenofovirin China because the medicine is not yet registered. The government plans tointroduce free second-line treatment in three “pilot” provinces—Anhui, Henan, andHubei—and officials have indicated that strict entry requirements will be imposed,including confirmation of drug resistance (MoH, July 2007). Treatment authoritiessay it is critical to impose such restrictions to ensure that second-line ARVs are onlyused by patients who truly need them, and so that doctors are properly trained andable to monitor patients on second-line treatment.It is unclear if any arrangements have been made to allow individual patients ordoctors outside of these three provinces to access second-line ARVs, or if they willhave to wait until the results from the pilot sites are analyzed.Access to second-line ARVs has not improved significantly since the publicationin July 2007 of the previous Missing the Target report. It is not for lack ofopportunities. Contacts within the government and among NGOs report, forexample, that one major drug company (Gilead) in August 2007 submittedan application for tenofovir to be registered in China and that the companyhas expressed its willingness to cooperate with the Chinese government onan accelerated access program while awaiting regulatory approval. Such anarrangement would include the donation of tenofovir until regulatory approval isreceived, and subsequent purchase at the already agreed price of $1 per personper day. Yet despite the urgent need for second-line treatment, governmentregulators were moving slowly (as of October 2007) to respond. The delay isespecially problematic because the government’s plan to start providing second-lineARVs on a pilot basis in three provinces cannot proceed without tenofovir.69