HCV Treatment for HIV-Coinfected Patients — Getting Better All the Time

August 10, 2015

HCV Treatment for HIV-Coinfected Patients — Getting Better All the Time

  1. Helmut Albrecht, MD

Two open-label studies confirm that a once-daily combination of sofosbuvir plus either ledipasvir or daclatasvir cures hepatitis C virus infection in most such patients.

  1. Helmut Albrecht, MD

Due to shared transmission routes, hepatitis C virus (HCV) affects many people living with HIV infection. Despite better HIV treatment options, HCV continues to be a major cause of morbidity and mortality in such individuals. The newer HCV treatment regimens have been proven efficacious and well tolerated in HIV-uninfected patients, but more data are needed regarding coinfected individuals, given the significant drug interactions between antiretrovirals and anti-HCV medications.

Now, in two manufacturer-supported, open-label trials, researchers have examined the efficacy of once-daily combination regimens involving the nucleotide analog inhibitor sofosbuvir plus one of two FDA-approved NS5A inhibitors — ledipasvir (S/L; n=335; 55% treatment-experienced and 20% with compensated cirrhosis) or daclatasvir (S/D; n=203; 25% treatment-experienced and 14% with cirrhosis).

Cure rates (i.e., rates of sustained virologic response at posttreatment week 12) were 96.1% overall for the 12-week S/L regimen, 97.0% for treatment-naive patients with 12 weeks of S/D, 76.0% for treatment-naive patients with 8 weeks of S/D, and 98.1% for treatment-experienced patients with 12 weeks of S/D. Side effects were generally mild, and not a single patient stopped therapy because of adverse events.

Comment

Although some of the subgroups were too small to allow firm conclusions, S/L and S/D resulted in extraordinarily high HCV cure rates in HIV-coinfected patients in a variety of circumstances (HCV of various genotypes; participants with cirrhosis or early infection, pretreated or naive). Daclatasvir, despite its seeming efficacy, suffers a major competitive disadvantage, given that the S/D combination costs significantly more than S/L coformulated single-tablet regimen. And although S/D has previously demonstrated good efficacy in patients with genotype 3 monoinfection, this study did not include enough such patients to allow evaluation of efficacy. Another hope — that the addition of daclatasvir would allow shortening therapy duration in treatment-naive patients and thereby decrease treatment cost — was tempered by the much-poorer response rate in the 8-week arm.

It is encouraging to see that we have a growing arsenal of interferon- and ribavirin-free once-daily options to treat HIV/HCV-coinfected patients. Dosage adjustment for concomitant antiretroviral medications, as occurred in the S/D trial, now allows successful treatment of more of these individuals. The unmet need is a more affordable option that would allow us not only to treat coinfected patients with advanced disease, but also to address HCV at the population level without bankrupting the healthcare system.

Editor Disclosures at Time of Publication

  • Disclosures for Helmut Albrecht, MD at time of publication Grant / Research support Health Resources and Services Administration; Centers for Disease Control and Prevention Leadership positions in professional societies Columbia Medical Society; South Carolina Infectious Diseases Society

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