In HIV patients coinfected with hepatitis C virus genotype 1 or 4, rates of sustained virologic response — defined as the absence of hepatitis C RNA — at 12 weeks reached 96% with a fixed-dose combination of ledipasvir and sofosbuvir (Harvoni, Gilead Sciences), results from the ION-4 study show.
"The beauty of this therapy is the high cure rate and the lack of significant drug–drug interactions" with HIV medications, said Meena Bansal, MD, from the Icahn School of Medicine at Mount Sinai Hospital in New York City.
The combination is one of the promising new therapies that are changing the options for this patient group, Dr Bansal told Medscape Medical News. More combinations will be coming out in the next year, she added.
Ease of use is important because these patients already take multiple medications. With this combination, "you're talking one pill once a day with a very good safety profile," she said.
Study results were reported at the 8th International AIDS Society Conference in Vancouver, British Columbia, Canada, and published online in the New England Journal of Medicine to coincide with the presentation.
"This is a definitive study that shows that people who are coinfected do extremely well on these newer combination hep C drugs," said Stacey Rizza, MD, from the Mayo Clinic in Rochester in Minnesota. "In fact, they do as well as people who are monoinfected."
The benefits of these drugs have been known for those with hepatitis C alone, as have the barriers presented by the cost, which can be more than $1000 a pill, she said.
In the past 5 years, it's gone from a flip of a coin that a patient would respond "to virtually universal cure for the vast majority of people. They're only pills, it's a shorter course, but it's radically changed hep C therapy," she explained. However, "they are so ridiculously expensive that the majority who have hep C and need it can't get the drug."
As more of these combinations get approved, the free market will eventually bring the cost down, she pointed out.
Participants Recruited From 60 Sites
Adults were recruited for the study from 60 sites in Canada, New Zealand, Puerto Rico, and the United States. Of the 335 patients enrolled, 34% were black, 55% had previously been treated for hepatitis C, and 20% had cirrhosis.
All had been receiving a stable, protocol-approved antiretroviral regimen for HIV for at least 8 weeks before screening, and all had evidence of HIV viral suppression, report Susanna Naggie, MD, from the Duke Clinical Research Institute in Durham, North Carolina, and colleagues.
Study participants received an antiretroviral regimen of tenofovir and emtricitabine with efavirenz, rilpivirine, or raltegravir. In addition, all received the fixed-dose combination of ledipasvir, an NS5A inhibitor, and sofosbuvir, a nucleotide polymerase inhibitor.
A sustained response was achieved by 322 of the 335 patients.
Table. Sustained Virologic Response at 12 Weeks
|Patient Group||Percent||95% Confidence Interval|
|Hepatitis C genotype 1a||96||93–98|
|Hepatitis C genotype 1b||96||89–99|
|Hepatitis C genotype 4||100||63–100|
Response rates were similar, regardless of previous treatment or whether the patients had cirrhosis. The most common adverse events were headache (25%), fatigue (21%), and diarrhea (11%). There were no discontinuations because of adverse events.
Tolerability is huge for this population; older treatments with interferon historically have not been well tolerated, Dr Naggie told Medscape Medical News.
"Not a single one of the 335 patients — not a single one — discontinued therapy," she emphasized.
From the perspective of the patient, these findings are critically important. "There's been bias for patients and providers to not view HIV patients as candidates for treatment because they never did as well," she explained.
Around the world, there are about 4 million to 5 million people coinfected with HIV and hepatitis C. These patients have higher rates of cirrhosis, hepatocellular carcinoma, and liver decompensation than patients with hepatitis C alone.
All Who Had Relapses Were Black
All 10 of the patients who had hepatitis C relapses — meaning they completed treatment and then relapsed — were black, which the researchers could not explain.
"This is the first and only study to show this in any regimen, regardless of HIV infection," Dr Naggie reported. It needs to be addressed because black patients are often under-represented in clinical trials, she added.
In this country, black patients "carry the significant burden of this disease, yet they are always a minority population in every clinical trial done on this disease. That is an issue," she said.
The study was funded by Gilead Sciences. Dr Bansal was a site investigator for this study at Mount Sinai. Dr Naggie reports receiving support and personal fees from Gilead Sciences and personal fees from AbbVie, Bristol-Myers Squibb, Janssen, and Merck. Some of her coauthors report receiving support and/or fees from Gilead Sciences, the National Institute of Allergy and Infectious Diseases, the National Institute on Drug Abuse, Vertex Pharmaceuticals, UpToDate, Bristol-Myers Squibb, AbbVie, Janssen, Merck, Achillion, GlaxoSmithKline/ViiV, Pfizer, Boehringer Ingelheim, Inovio, and Sangamo.
8th International AIDS Society (IAS) Conference. Presented July 21, 2015.
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Cite this: Single-Pill Hep C Treatment Effective in Patients With HIV - Medscape - Jul 22, 2015.