Article: Non-adherence is the most important risk factor for ledipasvir/sofosbuvir HCV treatment failure in the real world – Author/Source: Dost Sarpel / Abstract # 1978
Aim/Results: Ledipasvir plus sofosbuvir fixed-dose combination (Harvoni-one pill once-a-day) is approved to treat hepatitis C virus (HCV) genotypes 1, 4, 5, and 6 with very high cure rates—up to 98%. This includes treatment naïve and experienced genotype 1 HCV-infected patients with or without cirrhosis in clinical trials and importantly 91-97% in ‘real world settings’. The authors wanted to understand what factors influenced the small number of treatment failures.
The authors collected demographic, virologic and clinical data through 24 week-post treatment on people who were treated with Harvoni between November 2014 and March 2016 at Mount Sinai but who were not cured. Patients self-reported their medication adherence to their medical provider. Non-adherence in this study was defined as missing at least 7 doses of Harvoni.
Conclusions: 43 patients did not achieve a sustained virological response (SVR/cure). Eighty-six percent (n=37) were male, the average age was 59 yo (range 34-80), mostly Black (53.5%). Thirty-eight patients had genotype 1 HCV (26 had genotype 1a, 12 had genotype 1b, and one had genotype 1l), eleven patients were HIV/HCV co-infected patients (26%) and 21 (49%) patients had liver cirrhosis. Intended treatment duration was 12 weeks in 33 (77%) patients, 24 weeks in 5 (12%) patients, and 8 weeks in 5 (12%) patients. During therapy, 38 (87%) had undetectable HCV viral load, while 4 never became viral load negative, despite a ≥ 4-log reduction. No patients had HCV viral breakthrough.
Ten patients (26%) missed 7 or more doses—due to not taking medication as prescribed (number =4 patients), hospitalization (number =3 patients), loss of medication (number=1 patient), failure to refill medication (number =1 patient), and side effects (number=1 patient). Treatment failure was mostly associated with non-adherence.
Conclusion: Harvoni has a very high cure rate, but a number of patients have not been cured. Missing 7 or more doses (non-adherence) was the single most important risk factor for treatment failure in the current study. The authors stated that providers need to communicate the importance of adherence to HCV medications to their patients.
Editorial Comments: We now have medications that can cure almost everyone. But there is a need to support people with various strategies to help them to take their medications 100% of the time. Medication adherence is one of the most difficult issues facing treatment of any disease. It requires the collaboration of the person taking the medication, their loved ones and their medical team to coordinate the treatment and care. It’s not about just popping a pill.
For help with adherence check out our two fact sheets on adherence:
Easy C Facts: Taking HCV Meds – Adherence – click here
HCSP Fact Sheet: Adherence to HCV Medications – click here