Background: The once-daily fixed-dose combination (FDC) tablet of sofosbuvir/velpatasvir
(SOF/VEL) administered for 12 weeks, has demonstrated high efficacy in genotypes 1-6 HCV-infected patients. A prospective clinical trial was performed to evaluate the safety and efficacy of SOF/VEL in patients co-infected with HCV and HIV-1.
Methods: This single arm, open label study enrolled treatment naïve- and -experienced HCV/HIV co-infected patients of all HCV genotypes with or without cirrhosis. Patients on stable antiretroviral (ARV) regimens with fully suppressed HIV RNA received SOF/VEL (400 mg/100 mg daily) for 12 weeks. ARV regimens included emtricitabine/tenofovir disoproxil fumarate or abacavir/lamivudine with raltegravir, cobicistat/elvitegravir, rilpivirine, ritonavir-boosted atazanavir, darunavir or lopinavir. Safety evaluations included adverse event (AE) and standard laboratory parameter monitoring including renal function monitoring, CD4 count, and HIV-1 RNA levels. The primary endpoint was sustained virologic response 12 weeks after treatment (SVR12).
Results: 106 patients were enrolled and treated with SOF/VEL for 12 weeks. 86% were male, 45% were black, 77% had IL28B non CC genotypes, 29% had prior treatment failure (primarily PegIFN/RBV), and 16% had compensated cirrhosis. The genotype distribution was 62% GT1a, 11% GT1b, 10% GT2, 11% GT3, and 5% GT4. Median baseline CD4 count was 548 cells/uL (range: 183-1513 cells/uL) with a median estimated glomerular filtration rate of 97 mL/min (range 57- 198 mL/min). Boosted protease inhibitor (PI) regimens were the most commonly used regimen (Table 1). In this interim analysis with 95% of patients beyond treatment week 4 time point, the most common AEs were fatigue (19%), headache (14%), and nausea (7%). One patient experienced a serious adverse event (toe infection), considered unrelated to study drugs. No patient experienced confirmed HIV virologic rebound (HIV-1 RNA ≥400 copies/mL). No significant changes in lab abnormalities including renal function were observed. Efficacy and safety outcomes including complete SVR12, HIV parameters, and the impact of HCV resistance variants on outcomes will be presented.
Conclusions: The single tablet regimen of SOF/VEL administered for 12 weeks was well tolerated in HCV/HIV co-infected patients with GT 1-4, regardless of past treatment experience or presence of cirrhosis.

ARV regimen at enrollmentPI + NRTIIntegrase + NRTINNRTI + NRTICombination (at least 2 of the following classes: PI, NNRTI or integrase)
Number n (%)50 (47%)36 (34%)13 (12%)7 (7%)
[PI: protease inhibitor, NRTI: nucleoside reverse transcriptase inhibitor, NNRTI: Non- nucleoside reverse transcriptase inhibitor]