Treatment for hepatitis C in sub-Saharan Africa can
produce cure rates as high as those seen in industrialised countries, with high
adherence and minimal side-effects, according to a presentation yesterday at the 9th International AIDS Society Conference on HIV Science (IAS
2017) in Paris, France.
These findings support scaling
up hepatitis C virus (HCV) screening and access to treatment in
resource-limited countries, said presenter Karine Lacombe of Saint-Antoine Hospital and Inserm in Paris.
Direct-acting antivirals (DAAs) used in
interferon-free regimens have changed the treatment paradigm for hepatitis C.
Studies conducted in Europe and North America have shown cure rates exceeding 90%,
even for difficult-to-treat patient populations such as those with liver
- decompensated cirrhosis
The later stage of
cirrhosis, during which the liver cannot perform some vital functions and
complications occur. See also ‘cirrhosis’ and ‘compensated cirrhosis’.
To date, there has been little research on hepatitis C therapy
in resource-limited settings, and access to care and treatment is limited. However, the
World Health Organization has committed to expanding HCV screening and treatment worldwide, aiming to test
90% and treat 80% of people living with hepatitis B or C by 2030.
Lacombe and colleagues conducted the TAC ANRS 12311 trial, sponsored by
the French National Agency for Research on AIDS and Viral Hepatitis
(ANRS), to assess
the feasibility, efficacy and safety of interferon-free DAA treatment in
Cameroon and Ivory Coast.
in October 2015, this open-label study enrolled 120 adults who had not
previously been treated for hepatitis C; 110 of them were included in this
over half were men and the median age was 55 years. A third each had HCV
genotypes 1, 2 and 4. About 30% had HIV and HCV co-infection. Of these, 84% had HIV
RNA below 50 copies/ml and the median CD4 count was 624 cells/mmm3. One
in ten had compensated liver cirrhosis. People with hepatitis B or severe
decompensated cirrhosis were excluded.
Participants with genotype 1 or
4 were treated with sofosbuvir/ledipasvir (Harvoni)
for 12 weeks, while those with genotype 2 received sofosbuvir plus weight-based
After 12 weeks of
post-treatment follow-up, 89% achieved sustained virological response (SVR12),
or continued undetectable HCV RNA, considered a cure. Cure rates were 88% for genotype 1, 90% for
genotype 2 and 89% for genotype 4. The SVR12 rate was a bit lower for those
with cirrhosis, at 78%. HIV co-infection had no impact on efficacy, adherence
Treatment was safe and well
tolerated, with no severe adverse events or deaths. No one was lost to
follow-up, and all but one completed the 12-week treatment course. The
remaining participant discontinued treatment after 8 weeks due to travelling
abroad, but still achieved SVR12. Four participants developed anaemia (haemoglobin below
100 g/l) and reduced their ribavirin dose.
Based on these
findings, "It is time to scale up HCV screening and advocate for treatment
access for those in need
in resource-limited countries,
to make global HCV
elimination a reality for all," the researchers concluded.
The cure rates in this study
are in line with those seen in Europe and North America, with excellent
tolerability and no safety issues, according to Dr Lacombe.
"This is very good proof that when treatment is available, patients
are adherent and keen on taking treatment – this is the time to advocate for
larger access to DAAs in Africa," she said. She added that the infrastructure
developed for HIV can also be used for hepatitis C.
However, the high cost of DAAs remains a barrier and advocacy is needed
to get more generic drugs on the market, Dr Lacombe said. Even at a cost of
US$100 per treatment course, many people will not be able to pay and lower-income
countries will require assistance from international funders. Expanded
screening is also critical, as a majority of people living with HCV worldwide
do not know they have HCV.
"The first results of the ANRS TAC trial now argue strongly that
access to DAAs should be extended without delay to HCV-infected patients in
Africa and, more generally, in all resource-limited countries," ANRS
director François Dabis said in a press release.