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Sovaldi-based HCV therapy safe for patients with cancer, linked to NHL remission

Sovaldi-based therapy was safe and effective in as short as 8 weeks for treating hepatitis C in patients with cancer and may induce remission of non-Hodgkin’s lymphoma, according to a recently published study.

“No recommendations are yet available for HCV-infected patients with cancer,” Harrys A. Torres, MD, from the University of Texas MD Anderson Cancer Center, and colleagues wrote. “Our results show that [Sovaldi]-based therapy is safe and effective in HCV-infected patients with various malignancies and it may be administered for short duration.”

Torres and colleagues initially enrolled 153 patients with HCV and cancer, with 12 later excluded due to discontinuation of HCV therapy. The most common cancers included hepatocellular carcinoma (18%), multiple myeloma (9%) and diffuse large B-cell lymphoma (7%). They were treated with one of the following medications or combinations: Sovaldi (sofosbuvir, Gilead Sciences), Daklinza (daclatasvir, Bristol-Myers Squibb) with sofosbuvir, Olysio with sofosbuvir, Harvoni (sofosbuvir/ledipasvir, Gilead Sciences) or Epclusa (sofosbuvir/velpatasvir, Gilead Sciences).

At 12 weeks, the overall sustained virologic response rate was 91% (95% CI, 85-95). Of the 110 patients with genotype 1, the overall SVR rate was 91%. All 17 patients with genotype 1 who received sofosbuvir/ledipasvir for 8 weeks achieved SVR. The SVR rate was 67% (95% CI, 39-86) in the 12 patients with genotype 3.

Twenty-seven of 32 patients who were previously excluded from early-phase cancer clinical trials due to HCV at enrollment were granted access to investigational cancer treatments after starting DAA therapy, 19 of whom did not have an HCV-related malignancy.

At 6 months posttherapy, two patients with indolent B-cell NHL achieved SVR12 and complete NHL remission, two others achieved SVR with stable NHL, one achieved SVR with stable NHL and later achieved partial remission after cancer therapy, and one patient achieved SVR but developed NHL recurrence.

Adverse events were similar in type and prevalence to the general population. All seven patients who experienced a serious adverse event achieved SVR and had no cancer progression or relapse at 6 months posttherapy.

“We observed SVR12 rates over 90%, nearly matching the response rates in the general population, including patients receiving ledipasvir/sofosbuvir therapy for short duration,” Torres and colleagues wrote. “We also found that sofosbuvir-based therapy was generally safe and well tolerated, opening access to investigational cancer treatment for many patients and improving oncologic outcomes of patients with selected HCV-associated NHLs.” – by Talitha Bennett

Disclosure: Torres reports he is or has been a paid scientific advisor for Gilead Sciences, Dynavax Technologies, Janssen Pharmaceuticals, Merck, Genentech and Vertex Pharmaceuticals. The other authors report no relevant financial disclosures.