Combo Drug Shows High Hepatitis C Cure Rates in Patients Coinfected with HIV

An interferon/ribavirin-free pill that combines two drugs to treat patients with certain genotypes of hepatitis C who are also infected with HIV was found to be highly effective in a 12-week trial, clearing the hepatitis C virus from almost all the patients involved, according to results released at the 2015 Conference on Retroviruses and Opportunistic Infections in Seattle, WA.

It is estimated that 7 million people around the world are infected with both HIV and hepatitis C. Historically patients who were infected with the hepatitis C virus and HIV did not respond well to treatments with interferon and ribavirin. With sofosbuvir-based regimens, coinfected patients have obtained similar sustained virologic response (SVR) rates as those infected only with hepatitis C, according to the study abstract presented by Susanna Naggie, MD, MHS, Duke Clinical Research Institute, in Durham, NC.

A once-daily combination pill of 400 mg of sofosbuvir, a nucleotide analog polymerase inhibitor, and 90 mg of the NS5A inhibitor ledipasvir was given to patients who were coinfected with hepatitis C and HIV. The patients had not been treated for hepatitis C but were on stable, approved antiretroviral regimens for HIV treatment.

Patients with compensated cirrhosis were allowed to enroll in the trial. Antiretroviral regimens of tenofovir and emtricitabine with raltegravir, efavirenz, or rilpivirine were permitted. Patients were monitored for adverse events, standard laboratory measurements, enhanced renal toxicity, CD4 count, and HIV-1 RNA levels.

The study’s primary efficacy endpoint was SVR at 12 weeks.

Out of the 335 patients enrolled in the study, 75 percent had genotype 1a hepatitis C, 23 percent had genotype 1b, and 2 percent had genotype 4, according to the study abstract. Most were men (82 percent), white (61 percent) and ranged in ages from 26 to 72 years old with an average age of 52.

Study results indicate that overall the SVR12 rate was 96 percent (320 out of 335 patients). There were two patients who had on-treatment virologic failure and 10 patients who had virologic relapse after discontinuing treatment, according to the abstract. Among non-cirrhotic and cirrhotic patients the SVR12 was similar (96 percent and 94 percent, respectively). It also was similar among treatment-naïve and treatment-experienced patients (94 percent and 97 percent respectively).

No patient had confirmed HIV virologic rebound. None stopped taking study drug as a result of an adverse event. The most common adverse events were headache, fatigue, and diarrhea.

The study authors concluded that the single-tablet, interferon- and ribavirin-free regimen of ledipasvir and sofosbuvir administered daily for 12 weeks was highly effective and well tolerated in treatment-naïve and treatment-experienced patients with genotype 1 or 4 hepatitis C also infected with HIV-1, including patients with cirrhosis.