The Week 12 Early-Stopping Rule

Although treatment discontinuations occur for other reasons—usually side effects
and adverse events—many clinicians and their coinfected patients may decide to stop treatment at Week 12 if the patient does not have an early virological response (EVR), defined as achieving a 2-log drop in HCV RNA or undetectable HCV RNA after 12 weeks of treatment. As with HCV monoinfection, the likelihood of SVR in the absence of EVR is extremely low. Clinical trials of HCV treatment in HIV/HCV-coinfected patients have reported that 94 to 100 percent of participants who did not have EVR also did not achieve SVR.96,128,129 Some clinicians and patients may prefer to continue HCV treatment in the absence of an EVR because some patients may have a delayed response to treatment. The Week 12 “early-stopping rule,” however, spares nonresponders from the side effects and expense of HCV treatment.